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CompletedNCT04130737TORUS2Updated Jul 10, 2026Results posted

The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study

An interventional study of TORUS Stent Graft System in Peripheral Arterial Disease, sponsored by Endologix. Completed at 32 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Endologix · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
188
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The primary objective of the TORUS 2 IDE Clinical Study is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the native SFA or the superficial femoral and/or proximal popliteal arteries.

Read the detailed description

Peripheral Arterial Disease, specifically in the superficial femoral arteries (SFA) and proximal popliteal arteries, are treated by a range of alternative practices and procedures for the patient population identified in the indications for use statement. Non-invasive approaches include exercise and drug therapy.

Minimally-invasive approaches include endovascular intervention using percutaneous transluminal angioplasty using a plain or drug-coated balloon, stents (bare metal, drug-eluting and covered) and various modalities of atherectomy.

SFA Stent Graft Systems have a clinical history that demonstrates that this device type is well understood, and the benefits and risks are well-characterized, i.e. mature technology.

Endologix believes that the clinical performance of the TORUS stent would be comparable to marketed SFA Stent Graft System. The TORUS 2 IDE Clinical Study will confirm this and is designed to demonstrate the safety and effectiveness of the TORUS Stent Graft System in patients with SFA and/or proximal popliteal artery disease

02

Conditions studied

  • Peripheral Arterial Disease

Keywords

  • Peripheral Artery Disease
  • Superficial Femoral Artery
  • Popliteal Artery
  • Stent Graft
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient is male or female, with age > 18 and ≤ 90 years at date of enrollment.
  2. Patient provides written informed consent before any study-specific investigations or procedures.
  3. Patient is willing to undergo all follow-up assessments according to the specified schedule over 36 months.
  4. Patient is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
  5. Patient has symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion or restenosis of the native femoropopliteal artery.
  6. Patient has PAD classified as Rutherford classification 2, 3 or 4.
  7. Patient has documented PAD by either (i) a resting ankle-brachial index (ABI) of ≤ 0.90 (or ≤ 0.75 after exercise of the target limb). Resting toe brachial index (TBI) is performed only if unable to reliably assess ABI. TBI must be \<0.70; or (ii) Normal ABI with angiographic, ultrasound, MRA, or CT evidence of ≥ 60% diameter stenosis.
  8. Patient has single or multiple stenotic, restenotic or occlusive lesions within the native femoropopliteal artery ("target lesions") that can be crossed with a guidewire and fully dilated.
  9. Single target lesion must be covered by a single stent. Tandem target lesions are considered a single continuous lesion if the gap between lesions is ≤ 5 cm and > 30% diameter stenosis between the lesion(s).
  10. Target lesion(s) eligible for treatment under the protocol are at least least 3 cm above the bottom of the femur.
  11. Target lesion(s) reference vessel diameter is between 5.0 mm and 6.7 mm by operator's visual estimate.
  12. Target lesion measures ≥ 80 mm to ≤ 180 mm in overall length, with ≥ 60% diameter stenosis by operator's visual estimate. Tandem target lesions are considered a single continuous lesion if the gap between lesions is ≤ 5 cm and > 30% diameter stenosis between the lesion(s).
  13. Patient has a patent popliteal artery (no stenosis ≥ 50%) distal to the treated segment.
  14. Patient has at least one patent infrapopliteal vessel (\< 50% stenosis) with run-off to the ankle.

Exclusion criteria

Exclusion Criteria:

  1. Patient is unable or is unwilling to comply with the procedural requirements of the study protocol or will have difficulty in complying with the requirements for attending follow-up visits.
  2. Patient has a comorbidity that in the investigator's opinion would limit life expectancy to less than 24 months.
  3. Patient has any planned major surgical procedure (including any amputation of the target limb) within 30 days after the index procedure for this study.
  4. Patient has a target vessel that has been treated with any type of surgical procedure prior to enrollment.
  5. Patient has a target vessel that has been treated with bypass surgery.
  6. Patient has PAD classified as Rutherford classification 0, 1, 5 or 6.
  7. Patient has known or suspected active systemic infection at the time of enrollment.
  8. Patient has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR (international normalized ratio) >1.8.
  9. Patient has a stroke diagnosis within three months prior to enrollment.
  10. Patient has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
  11. Patient has a contraindication to antiplatelet, anticoagulant or thrombolytic therapies.
  12. Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-medicated.
  13. Patient has known allergy to titanium, nickel or tantalum (does not include mild contact dermatitis due to nickel allergy).
  14. Patient has received thrombolysis within 72 hours prior to the index procedure.
  15. Patient has acute or chronic renal disease (e.g., as measured by a serum creatinine of > 2.5 mg/dL or > 220 μmol/L or GFR \< 30 ml/min), or on peritoneal or hemodialysis.
  16. Patient requiring coronary intervention within seven days prior to enrollment.
  17. Patient is pregnant or breast-feeding.
  18. Patient is participating in another research study involving an investigational product (pharmaceutical, biologic or medical device).
  19. Patient has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
  20. Patient has significant disease or obstruction (≥ 50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤ 30% residual stenosis, without complication).
  21. Patient has no patent (≥ 50% stenosis) outflow vessel providing run-off to the ankle.
  22. There is a lack of full expansion in the predilatation balloon.
  23. Evidence of aneurysm or acute thrombus in target vessel.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
188 participants (actual)

Study arms

  • Experimental
    TORUS Stent Graft System

    The TORUS Stent Graft System (SGS) is comprised of a Stent Graft (SG) and a Stent Graft Delivery System (SGDS).

    Device: TORUS Stent Graft System

Interventions

  • DeviceTORUS Stent Graft System

    The TORUS Stent Graft is an intravascular prosthesis intended to improve blood flow in the area in which it is implanted and the TORUS Stent Graft Delivery System is a standard pin-and-pull delivery system used to implant the SG in the desired area. Use of the TORUS Stent Graft allows for improving blood flow in the peripheral vasculature.

    Also known as: TORUS Stent Graft, PQ Bypass™ Stent Graft System

05

What researchers measure

Primary outcomes

  1. Freedom From a Major Adverse Event (MAE)

    An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR)

    Time frame: 30 days

  2. Primary Patency

    Primary patency is defined as the absence of clinically-driven target lesion revascularization (CD-TLR) and absence of recurrent target lesion diameter stenosis \>50% by duplex ultrasound with a peak systolic velocity ratio of \>2.5.

    Time frame: 12 months

Secondary outcomes

  1. Technical Success

    Technical success is defined as the ability to cross and dilate the lesion to achieve residual stenosis of ≤30%

    Time frame: At the time of the index procedure

  2. Procedural Success

    Procedural Success is defined as technical success with out any MAEs.

    Time frame: Within 24 hours of the procedure

  3. Major Adverse Event (MAE) Rate

    Composite rate of all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR).

    Time frame: 12 months

  4. Major Amputation on Target Limb

    Major Amputation on Target Limb were adjudicated by the Clinical Event Committee (CEC), and rates were tabulated through 30 days, 6 months, 12 months, 24 months, and 36 months

    Time frame: Through 36 months

  5. Patency Rate

    Absence of CD-TLR and absence of recurrent target lesion diameter stenosis \>50% by duplex ultrasound with a peak systolic velocity ratio of \>2.5.

    Time frame: Through 12 months

  6. Clinically Driven Target Lesion Revascularization

    Clinically Driven Target Lesion Revascularization were adjudicated by the Clinical Event Committee (CEC), and rates were tabulated through 30 days, 6 months, 12 months, 24 months, and 36 months

    Time frame: Through 36 months

  7. Walking Improvement Questionnaire (WIQ) Assessment

    Walking Impairment Questionnaire (WIQ) - The WIQ is a patient-reported outcome measure that assesses self-reported walking ability in individuals with peripheral arterial disease (PAD). It evaluates perceived difficulty performing walking tasks related to walking distance, walking speed, and stair climbing, which reflect functional limitations caused by PAD. Scale Structure and Scoring: The WIQ consists of three subscales: Walking Distance Walking Speed Stair Climbing Each subscale is scored from 0 to 100, where higher scores indicate better walking function. The Composite PAD Score (PADSCORE) is calculated by averaging the three subscale scores, resulting in a total composite score ranging from 0 to 100. Scale Ranges and Interpretation: WIQ Subscale Scores: 0 (worst function) to 100 (best function) WIQ Composite PAD Score: 0 (worst walking impairment) to 100 (no walking impairment) Direction of Outcome: For all WIQ scores, higher values represent a better outcome

    Time frame: Change from baseline to 12-Month follow-up (Collected at 1M,6M, and 12M)

  8. Quality of Life Assessment by the EQ5D VAS

    EuroQol Visual Analog Scale (EQ-5D-VAS) - The EQ-5D-VAS is a patient-reported outcome measure that assesses overall self-rated health-related quality of life. Participants rate their current health status using a visual analog scale anchored by the best and worst imaginable health states. Scale Structure and Scoring: Participants mark their perceived health status on a vertical visual analog scale. Scale Range and Interpretation: EQ-5D-VAS Score Range: 0 to 100 0: Worst imaginable health state (minimum) 100: Best imaginable health state (maximum) Direction of Outcome: Higher EQ-5D-VAS scores represent a better outcome, reflecting better perceived health-related quality of life. Lower scores indicate worse perceived health status. Unit of Measure: EQ-5D-VAS (scores on a scale)

    Time frame: Change from baseline to 12-Month follow-up (Collected at 1M, 6M, and 12M)

  9. Stent Fracture Rate

    Stent fracture rate using VIVA definitions

    Time frame: 12 months

  10. Change in Ankle-Brachial Index

    Change in Ankle-Brachial Index (ABI) in study subjects from baseline to each study interval through follow-up. Scale Structure and Scoring: Change in ABI was calculated as the difference between post-baseline ABI and baseline ABI for each participant for the target limb. ABI is a unitless ratio and does not have a fixed theoretical minimum or maximum value. Therefore, interpretation is based on clinically established thresholds rather than absolute scale limits: ABI ≤ 0.90: Consistent with peripheral arterial disease ABI 0.91-1.29: Generally considered normal arterial perfusion ABI ≥ 1.30: Suggestive of non-compressible arteries (e.g., arterial calcification) Change in ABI: Positive change (increase): Improvement in lower-extremity perfusion Negative change (decrease): Worsening arterial perfusion Direction of Outcome: For Change in ABI, higher (more positive) values represent a better outcome

    Time frame: Change from Baseline through 36 months

  11. Change in Toe Pressures

    Change in Toe-Brachial Index (TBI) in study subjects from baseline to each study interval through follow-up for the target limb. If ABI could not be assessed the TBI was assessed. Scale Structure and Scoring: TBI is calculated as: TBI = Toe systolic blood pressure ÷ Brachial systolic blood pressure Change in TBI was calculated as the difference between post-baseline TBI and baseline TBI for each participant. Scale Range and Clinical Interpretation: TBI is a unitless ratio and does not have a fixed theoretical minimum or maximum value. Interpretation is therefore based on clinically established thresholds rather than absolute scale limits: TBI \< 0.70: Consistent with peripheral arterial disease TBI ≥ 0.70: Generally considered normal digital perfusion For Change in TBI: A positive change (increase) indicates improvement in distal (digital) perfusion A negative change (decrease) indicates worsening arterial perfusion

    Time frame: Change from Baseline through 36 months

  12. Change in Rutherford Clinical Classification

    Clinical success: improvement in ≥ 1 Rutherford class

    Time frame: From procedure through 36 months

06

Results

Posted Jul 10, 2026

Participant flow

Participant flow — Overall Study
MilestoneTORUS Stent Graft System
Started188
Completed120
Not completed68

Outcome measures

PrimaryFreedom From a Major Adverse Event (MAE)

An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR)

Time frame:
30 days
Reported as:
Count of participants · Participants
Freedom From a Major Adverse Event (MAE)
ParticipantsTORUS Stent Graft System
Freedom From a Major Adverse Event (MAE)184
PrimaryPrimary Patency

Primary patency is defined as the absence of clinically-driven target lesion revascularization (CD-TLR) and absence of recurrent target lesion diameter stenosis \>50% by duplex ultrasound with a peak systolic velocity ratio of \>2.5.

Time frame:
12 months
Reported as:
Count of participants · Participants
Primary Patency
ParticipantsTORUS Stent Graft System
Primary Patency91
SecondaryTechnical Success

Technical success is defined as the ability to cross and dilate the lesion to achieve residual stenosis of ≤30%

Time frame:
At the time of the index procedure
Reported as:
Count of participants · Participants
Technical Success
ParticipantsTORUS Stent Graft System
Technical Success188
SecondaryProcedural Success

Procedural Success is defined as technical success with out any MAEs.

Time frame:
Within 24 hours of the procedure
Reported as:
Count of participants · Participants
Procedural Success
ParticipantsTORUS Stent Graft System
Procedural Success188
SecondaryMajor Adverse Event (MAE) Rate

Composite rate of all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR).

Time frame:
12 months
Reported as:
Count of participants · Participants
Major Adverse Event (MAE) Rate
ParticipantsTORUS Stent Graft System
Major Adverse Event (MAE) Rate45
SecondaryMajor Amputation on Target Limb

Major Amputation on Target Limb were adjudicated by the Clinical Event Committee (CEC), and rates were tabulated through 30 days, 6 months, 12 months, 24 months, and 36 months

Time frame:
Through 36 months
Reported as:
Count of participants · Participants
Major Amputation on Target Limb
ParticipantsTORUS Stent Graft System
Cumulative Complications within 30 days0
Cumulative Complications within 6 Months0
Cumulative Complications within 12 Months2
Cumulative Complications within 24 Months3
Cumulative Complications within 36 Months5
SecondaryPatency Rate

Absence of CD-TLR and absence of recurrent target lesion diameter stenosis \>50% by duplex ultrasound with a peak systolic velocity ratio of \>2.5.

Time frame:
Through 12 months
Reported as:
Count of participants · Participants
Patency Rate
ParticipantsTORUS Stent Graft System
Patency Rate91
SecondaryClinically Driven Target Lesion Revascularization

Clinically Driven Target Lesion Revascularization were adjudicated by the Clinical Event Committee (CEC), and rates were tabulated through 30 days, 6 months, 12 months, 24 months, and 36 months

Time frame:
Through 36 months
Reported as:
Count of participants · Participants
Clinically Driven Target Lesion Revascularization
ParticipantsTORUS Stent Graft System
Cumulative Complications within 30 days4
Cumulative Complications within 6 Months17
Cumulative Complications within 12 Months41
Cumulative Complications within 24 Months57
Cumulative Complications within 36 Months64
SecondaryWalking Improvement Questionnaire (WIQ) Assessment

Walking Impairment Questionnaire (WIQ) - The WIQ is a patient-reported outcome measure that assesses self-reported walking ability in individuals with peripheral arterial disease (PAD). It evaluates perceived difficulty performing walking tasks related to walking distance, walking speed, and stair climbing, which reflect functional limitations caused by PAD. Scale Structure and Scoring: The WIQ consists of three subscales: Walking Distance Walking Speed Stair Climbing Each subscale is scored from 0 to 100, where higher scores indicate better walking function. The Composite PAD Score (PADSCORE) is calculated by averaging the three subscale scores, resulting in a total composite score ranging from 0 to 100. Scale Ranges and Interpretation: WIQ Subscale Scores: 0 (worst function) to 100 (best function) WIQ Composite PAD Score: 0 (worst walking impairment) to 100 (no walking impairment) Direction of Outcome: For all WIQ scores, higher values represent a better outcome

Time frame:
Change from baseline to 12-Month follow-up (Collected at 1M,6M, and 12M)
Reported as:
Mean · PADSCORE
Walking Improvement Questionnaire (WIQ) Assessment
PADSCORETORUS Stent Graft System
Walking Impairment Change from Baseline 1M24.7 ± 41
Walking Impairment Change from Baseline 6M28.9 ± 42.2
Walking Impairment Change from Baseline 12M18.3 ± 43.2
SecondaryQuality of Life Assessment by the EQ5D VAS

EuroQol Visual Analog Scale (EQ-5D-VAS) - The EQ-5D-VAS is a patient-reported outcome measure that assesses overall self-rated health-related quality of life. Participants rate their current health status using a visual analog scale anchored by the best and worst imaginable health states. Scale Structure and Scoring: Participants mark their perceived health status on a vertical visual analog scale. Scale Range and Interpretation: EQ-5D-VAS Score Range: 0 to 100 0: Worst imaginable health state (minimum) 100: Best imaginable health state (maximum) Direction of Outcome: Higher EQ-5D-VAS scores represent a better outcome, reflecting better perceived health-related quality of life. Lower scores indicate worse perceived health status. Unit of Measure: EQ-5D-VAS (scores on a scale)

Time frame:
Change from baseline to 12-Month follow-up (Collected at 1M, 6M, and 12M)
Reported as:
Mean · score on a scale
Quality of Life Assessment by the EQ5D VAS
score on a scaleTORUS Stent Graft System
Change from baseline to 1-Month6.6 ± 16.3
Change from baseline to 6-Month5.5 ± 19.1
Change from baseline to 12-Month7.4 ± 20.3
SecondaryStent Fracture Rate

Stent fracture rate using VIVA definitions

Time frame:
12 months
Reported as:
Count of participants · Participants
Stent Fracture Rate
ParticipantsTORUS Stent Graft System
Stent Fracture Rate0
SecondaryChange in Ankle-Brachial Index

Change in Ankle-Brachial Index (ABI) in study subjects from baseline to each study interval through follow-up. Scale Structure and Scoring: Change in ABI was calculated as the difference between post-baseline ABI and baseline ABI for each participant for the target limb. ABI is a unitless ratio and does not have a fixed theoretical minimum or maximum value. Therefore, interpretation is based on clinically established thresholds rather than absolute scale limits: ABI ≤ 0.90: Consistent with peripheral arterial disease ABI 0.91-1.29: Generally considered normal arterial perfusion ABI ≥ 1.30: Suggestive of non-compressible arteries (e.g., arterial calcification) Change in ABI: Positive change (increase): Improvement in lower-extremity perfusion Negative change (decrease): Worsening arterial perfusion Direction of Outcome: For Change in ABI, higher (more positive) values represent a better outcome

Time frame:
Change from Baseline through 36 months
Reported as:
Mean · Ankle-Brachial Index (ABI)
Change in Ankle-Brachial Index
Ankle-Brachial Index (ABI)TORUS Stent Graft System
Change from Baseline through 30 Days.2 ± .3
Change from Baseline through 6 Months.2 ± .3
Change from Baseline through 12 Months.3 ± .3
Change from Baseline through 24 Months.3 ± .3
Change from Baseline through 36 Months.3 ± .4
SecondaryChange in Toe Pressures

Change in Toe-Brachial Index (TBI) in study subjects from baseline to each study interval through follow-up for the target limb. If ABI could not be assessed the TBI was assessed. Scale Structure and Scoring: TBI is calculated as: TBI = Toe systolic blood pressure ÷ Brachial systolic blood pressure Change in TBI was calculated as the difference between post-baseline TBI and baseline TBI for each participant. Scale Range and Clinical Interpretation: TBI is a unitless ratio and does not have a fixed theoretical minimum or maximum value. Interpretation is therefore based on clinically established thresholds rather than absolute scale limits: TBI \< 0.70: Consistent with peripheral arterial disease TBI ≥ 0.70: Generally considered normal digital perfusion For Change in TBI: A positive change (increase) indicates improvement in distal (digital) perfusion A negative change (decrease) indicates worsening arterial perfusion

Time frame:
Change from Baseline through 36 months
Reported as:
Mean · Toe-Brachial Index (TBI)
Change in Toe Pressures
Toe-Brachial Index (TBI)TORUS Stent Graft System
Change from Baseline through 30 Days.2 ± .3
Change from Baseline through 6 Months.2 ± .3
Change from Baseline through 12 Months.3 ± .3
Change from Baseline through 24 Months.3 ± .3
Change from Baseline through 36 Months.3 ± .4
SecondaryChange in Rutherford Clinical Classification

Clinical success: improvement in ≥ 1 Rutherford class

Time frame:
From procedure through 36 months
Reported as:
Count of participants · Participants
Change in Rutherford Clinical Classification
ParticipantsTORUS Stent Graft System
30 Days154
6 Months139
12 Months133
24 Months102
36 Months69

Adverse events

Collected over Adverse Events are reported through 12 months. Serious Adverse events are reported through 12 Months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TORUS Stent Graft System24/188 (12.8%)85/188 (45.2%)136/188 (72.3%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventTORUS Stent Graft System
Vascular disordersVascular disorders60/188
General disorders and administration site conditionsGeneral disorders17/188
Infections and infestationsInfections and infestations14/188
Cardiac disordersCardiac disorders9/188
Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders9/188
Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications7/188
Respiratory, thoracic, and mediastinal disordersRespiratory, thoracic and mediastinal disorders7/188
Gastrointestinal disordersGastrointestinal disorders6/188
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Neoplasms benign, malignant and unspecified (incl cysts and polyps)4/188
Nervous system disordersNervous system disorders4/188
Most frequent other events
Showing 10 of 21
Most frequent other events
EventTORUS Stent Graft System
Vascular disordersVascular disorders81/188
General disorders and administration site conditionsGeneral disorders39/188
Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders30/188
Infections and infestationsInfections and infestations29/188
Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications18/188
Cardiac disordersCardiac disorders17/188
Nervous system disordersNervous system disorders12/188
Respiratory, thoracic, and mediastinal disordersRespiratory, thoracic and mediastinal disorders9/188
Gastrointestinal disordersGastrointestinal disorders6/188
Blood and lymphatic system disordersBlood and lymphatic system disorders5/188

Baseline characteristics

A total of 188 subjects (TORUS 2: 158 and TORUS 1: 30) were enrolled.

Age, Continuous
Age, Continuous(years)TORUS Stent Graft System
Mean69.7 ± 8.4
Sex: Female, Male
Sex: Female, Male(Participants)TORUS Stent Graft System
Female53
Male135
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)TORUS Stent Graft System
Hispanic or Latino17
Not Hispanic or Latino128
Unknown or Not Reported13
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TORUS Stent Graft System
American Indian or Alaska Native1
Asian3
Native Hawaiian or Other Pacific Islander3
Black or African American17
White130
More than one race0
Unknown or Not Reported4
Region of Enrollment
Region of Enrollment(Participants)TORUS Stent Graft System
United States158
Europe30
History of Renal Insufficiency
History of Renal Insufficiency(Participants)TORUS Stent Graft System
Count of participants32
History of Smoking
History of Smoking(Participants)TORUS Stent Graft System
Count of participants153
Diabetes Mellitus
Diabetes Mellitus(Participants)TORUS Stent Graft System
Count of participants94

7 further baseline measures are reported on the registry.

07

Study locations

32 sites
  • Southwest CVA
    Mesa, Arizona 85206, United States
  • Vascular Heart & Lung Associates
    Mesa, Arizona 85206, United States
  • Phoenix Cardiovascular Research Group
    Phoenix, Arizona 85018, United States
  • Yuma Cardiology Associates
    Yuma, Arizona 85349, United States
  • Arkansas Heart
    Little Rock, Arkansas 72211, United States
  • Bay Area Vein & Vascular Institute
    Burlingame, California 94010, United States
  • UCSF
    San Francisco, California 94143, United States
  • Rocky Mountain Regional VAMC
    Aurora, Colorado 80045, United States
  • The Vascular Experts
    Darien, Connecticut 06820, United States
  • First Coast Cardiovascular Institute
    Jacksonville, Florida 32256, United States
  • Palm Vascular Centers
    Miami Beach, Florida 33140, United States
  • Coastal Vascular & Interventional
    Pensacola, Florida 32504, United States
  • Florida Cardiology
    Winter Park, Florida 32792, United States
  • AMITA Health
    Elk Grove, Illinois 60007, United States
  • MedStar Health Research Insitute
    Hyattsville, Maryland 20782, United States
  • McLaren Bay Region
    Bay City, Michigan 48708, United States
  • Michigan Vascular Center
    Flint, Michigan 48507, United States
  • Eastlake Cardiovascular
    Roseville, Michigan 48066, United States
  • Northern Mississippi Medical Center
    Tupelo, Mississippi 38801, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Novant Health
    Charlotte, North Carolina 28204, United States
  • NC Heart & Vascular Research
    Raleigh, North Carolina 27607, United States
  • The Lindner Center for Research & Education
    Cincinnati, Ohio 45219, United States
  • Naadi
    Oklahoma City, Oklahoma 73116, United States
  • The Miriam Hospital
    Providence, Rhode Island 02906, United States
  • Prisma Health
    Greenville, South Carolina 29615, United States
  • North Central Heart
    Sioux Falls, South Dakota 57108, United States
  • Stern Cardiovascular Foundation
    Germantown, Tennessee 38138, United States
  • Texas Tech
    Lubbock, Texas 79430, United States
  • North Dallas Research Associates
    McKinney, Texas 75069, United States
  • Sentara Vascular Specialists
    Norfolk, Virginia 23507, United States
  • Bellin Hospital
    Green Bay, Wisconsin 54301, United States
08

References and documents

Study documents

  • Study protocol · Aug 1, 2020
  • Statistical analysis plan · Oct 11, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT04130737
Lead sponsor
Endologix
Collaborators
Syntactx, PQ Bypass, Inc.
Responsible party
Sponsor
First posted
Oct 17, 2019
Start date
Aug 13, 2018
Primary completion
Jan 6, 2023
Completion
Feb 14, 2025
Results posted
Jul 10, 2026
Last update
Jul 10, 2026

Study contacts

Ehrin Armstrong,, MD
principal investigator · Denver Veteran's Administration Hospital
Peter Schneider,, MD
principal investigator · University of California

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
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