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CompletedNCT04663867RESTOR-1Updated Feb 12, 2026Results posted

AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)

An interventional study of AngioSafe Peripheral CTO Crossing System in Peripheral Artery Occlusion and Peripheral Arterial Disease, sponsored by AngioSafe, Inc.. Completed at 18 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by AngioSafe, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
79
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study summary

The study is designed to evaluate the safety and efficacy of the AngioSafe Peripheral CTO Crossing System.

Read the detailed description

The purpose of the study is to demonstrate the safety and effectiveness of the AngioSafe Peripheral CTO Crossing System. The system facilitates the crossing of chronic total occlusions (CTOs) in the peripheral arteries of lower limbs. A minimum of 70 subjects will be treated across selected study enters within the U.S. and followed for 30 days.

02

Conditions studied

  • Peripheral Artery Occlusion
  • Peripheral Arterial Disease
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 79 is close to the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

This is the only study on the registry with AngioSafe, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Able and willing to comply with protocol requirements and sign informed consent form
  • ≥ 22 years of age
  • Peripheral arterial disease defined by Rutherford Clinical Classification (Category 2-5)
  • Peripheral artery disease in target extremity is confirmed by imaging (catheter angiography, computed tomographic angiography (CTA), and/or magnetic resonance angiography (MRA))

Angiographic Inclusion Criteria:

  • Target lesion in native de novo common femoral artery (CFA), superficial femoral artery (SFA), and/or popliteal artery
  • Vessel diameter(s) for target lesion is ≥ 3.0mm and ≤ 10mm
  • Subject's target lesion is a severely stenosed segment of ≤ 300 mm that involves the CTO(s)
  • Subject's target lesion involves at least one CTO that is 99-100% stenosed
  • Subject has at least one vessel with run-off to the foot

Exclusion criteria

Exclusion Criteria:

  • Systemic infection or an infection in extremity of target lesion
  • Target lesion within native vein or synthetic vessel grafts or in stent occlusion
  • Planned intervention in the contralateral limb during the study
  • Planned intervention in the target limb of the inflow vessels during the study
  • Planned intervention of lower extremities after study procedure within 30-day follow-up visit
  • Coagulopathy or bleeding diatheses, thrombocytopenia with platelet count less than 50,000/μl, or INR > 1.7
  • Antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated
  • Allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated
  • Allergy to nickel, titanium, urethane, nylon, or silicone
  • History of myocardial infarction within 30 days prior to enrollment/consent
  • History of stroke within 30 days prior to enrollment/consent
  • Chronic kidney disease (CKD) of stage 4 or greater based on an Estimated Glomerular Filtration Rate (eGFR) \<30ml/Min, unless the subject is on chronic renal replacement therapy
  • Hemoglobin levels \<10g/dL verified by a lab test no older than 14 days prior to enrollment, unless the subject has a history of chronic anemia at a stable level, no recent bleeding diathesis or history of blood transfusion in the last six weeks
  • Pregnant or nursing, for females of child-bearing potential (\< 50 years of age)
  • Participating in another interventional research study that may interfere with study endpoints
  • Prior major amputation (above ankle) in target extremity
  • Acute limb ischemia (ALI)
  • Prior unsuccessful attempt to cross the target lesion
  • Subject has had a procedure on the target limb or contralateral limb within 7 days
  • Subject has had a procedure on the target limb or contralateral limb within the past 30 days and is unstable
05

Study design

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

Study arms

  • Experimental
    AngioSafe Peripheral CTO Crossing System Procedure

    Use of AngioSafe Peripheral CTO Crossing System to facilitate the intraluminal placement of guidewires beyond Chronic Total Occlusions (CTOs) in the peripheral vasculature.

    Device: AngioSafe Peripheral CTO Crossing System

Interventions

  • DeviceAngioSafe Peripheral CTO Crossing System

    The AngioSafe Peripheral CTO Crossing System is intended to facilitate the intraluminal placement of guidewires beyond stenotic lesions, including chronic total occlusions (CTOs) in the peripheral vasculature.

06

What researchers measure

Primary outcomes

  1. Clinical Success of AngioSafe Peripheral CTO Crossing System

    Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner.

    Time frame: 24 Hours

Secondary outcomes

  1. Technical Success of AngioSafe Peripheral CTO Crossing System

    Technical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen.

    Time frame: Procedure, evaluated directly after performing the investigational procedure

  2. Procedural Success of AngioSafe Peripheral CTO Crossing System

    Procedural Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen without a procedural complication within 30 days after the procedure. Procedural complication is defined as the need for open or repeat endovascular surgical repair in the treated limb, or a major bleeding event.

    Time frame: 30 Days

  3. Evaluation of Intraluminal CTO Crossing Facilitated by the Peripheral CTO Crossing System, as Assessed by an Intravascular Ultrasound (IVUS).

    Post-procedure IVUS evaluation of Technical Success cases to determine if crossing was performed intraluminally.

    Time frame: Procedure, evaluated directly after performing the investigational procedure

  4. The Primary Endpoint (Clinical Success) in the Subgroups by the Degree of Calcification (None/Focal/Mild, and Moderate/Severe).

    Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner, analyzed by degree of calcification in two subgroups: None/Focal/Mild calcification, or Moderate/Severe calcification.

    Time frame: 24-hours

Other outcomes

  1. Lesion Crossing Time, Mean

    Lesion crossing time is defined as time starting from the placement of the Peripheral CTO Crossing System at the proximal cap to the time the guidewire is placed in the distal true vessel lumen.

    Time frame: Procedure, evaluated during the investigational procedure

  2. Lesion Crossing Time, Median

    Lesion crossing time is defined as time starting from the placement of the Peripheral CTO Crossing System at the proximal cap to the time the guidewire is placed in the distal true vessel lumen.

    Time frame: Procedure, evaluated during the investigational procedure

  3. Rutherford Clinical Classification (RCC) Assessment

    The mean change in the Rutherford Clinical Classification (RCC) assessment at 30 days versus baseline. The Rutherford Clinical Classification (RCC) Scale identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. The RCC Scale Categories and associated Clinical Descriptions are as follows: 0 - Asymptomatic, 1 - Mild claudication, 2- Moderate claudication, 3 - Severe claudication, 4 - Ischemic rest pain, 5 - Minor tissue loss, 6 - Ulceration or gangrene.

    Time frame: Baseline, 30-days

  4. Pain Numeric Rating Scale (NRS) Assessment

    The mean change in Pain Numeric Rating Scale (NRS) assessment at 30-days versus baseline. The Pain Numeric Rating Scale (Pain NRS) is a unidimensional measure of pain intensity in adults. The NRS is anchored by terms describing pain severity extremes, where 0 represents no pain and 10 represents the worst pain possible. The NRS Ratings and associated Clinical Descriptions are as follows: 0 - No Pain, 1-3 - Mild Pain, 4-6 - Moderate Pain, 7-9 - Severe Pain, 10 - Worst Pain Possible.

    Time frame: Baseline, 30-days

07

Results

Posted Feb 12, 2026

Participant flow

Participant flow — Overall Study
MilestoneFull Analysis Set (FAS), All Study Participants With Reported Outcome MeasuresExcluded Participants: Earlier Iteration of the Investigational DeviceExcluded Participant: Roll-In Subject
Started7441
Completed7441
Not completed000

Outcome measures

PrimaryClinical Success of AngioSafe Peripheral CTO Crossing System

Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner.

Time frame:
24 Hours
Reported as:
Count of participants · Participants
Clinical Success of AngioSafe Peripheral CTO Crossing System
ParticipantsFull Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Clinical Success of AngioSafe Peripheral CTO Crossing System65
SecondaryTechnical Success of AngioSafe Peripheral CTO Crossing System

Technical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen.

Time frame:
Procedure, evaluated directly after performing the investigational procedure
Reported as:
Count of participants · Participants
Technical Success of AngioSafe Peripheral CTO Crossing System
ParticipantsFull Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Technical Success of AngioSafe Peripheral CTO Crossing System65
SecondaryProcedural Success of AngioSafe Peripheral CTO Crossing System

Procedural Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen without a procedural complication within 30 days after the procedure. Procedural complication is defined as the need for open or repeat endovascular surgical repair in the treated limb, or a major bleeding event.

Time frame:
30 Days
Reported as:
Count of participants · Participants
Procedural Success of AngioSafe Peripheral CTO Crossing System
ParticipantsFull Analysis Set (FAS)
Procedural Success of AngioSafe Peripheral CTO Crossing System65
SecondaryEvaluation of Intraluminal CTO Crossing Facilitated by the Peripheral CTO Crossing System, as Assessed by an Intravascular Ultrasound (IVUS).

Post-procedure IVUS evaluation of Technical Success cases to determine if crossing was performed intraluminally.

Time frame:
Procedure, evaluated directly after performing the investigational procedure
Reported as:
Count of participants · Participants
Evaluation of Intraluminal CTO Crossing Facilitated by the Peripheral CTO Crossing System, as Assessed by an Intravascular Ultrasound (IVUS).
ParticipantsFull Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Total Intraluminal44
Partial Intraluminal with ≥50% of IVUS image frames Intraplaque7
Partial Intraluminal with <50% of IVUS image frames Intraplaque or Extraluminal3
Not Evaluable1
SecondaryThe Primary Endpoint (Clinical Success) in the Subgroups by the Degree of Calcification (None/Focal/Mild, and Moderate/Severe).

Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner, analyzed by degree of calcification in two subgroups: None/Focal/Mild calcification, or Moderate/Severe calcification.

Time frame:
24-hours
Reported as:
Count of participants · Participants
The Primary Endpoint (Clinical Success) in the Subgroups by the Degree of Calcification (None/Focal/Mild, and Moderate/Severe).
ParticipantsFull Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Moderate to Severe Calcification — Clinical Success46
Moderate to Severe Calcification — Failure7
None to Mild Calcification — Clinical Success19
None to Mild Calcification — Failure2
Other pre-specifiedLesion Crossing Time, Mean

Lesion crossing time is defined as time starting from the placement of the Peripheral CTO Crossing System at the proximal cap to the time the guidewire is placed in the distal true vessel lumen.

Time frame:
Procedure, evaluated during the investigational procedure
Reported as:
Mean · min
Lesion Crossing Time, Mean
minFull Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Lesion Crossing Time, Mean25 ± 4
Other pre-specifiedLesion Crossing Time, Median

Lesion crossing time is defined as time starting from the placement of the Peripheral CTO Crossing System at the proximal cap to the time the guidewire is placed in the distal true vessel lumen.

Time frame:
Procedure, evaluated during the investigational procedure
Reported as:
Median · min
Lesion Crossing Time, Median
minFull Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Lesion Crossing Time, Median9 (6 to 16)
Other pre-specifiedRutherford Clinical Classification (RCC) Assessment

The mean change in the Rutherford Clinical Classification (RCC) assessment at 30 days versus baseline. The Rutherford Clinical Classification (RCC) Scale identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. The RCC Scale Categories and associated Clinical Descriptions are as follows: 0 - Asymptomatic, 1 - Mild claudication, 2- Moderate claudication, 3 - Severe claudication, 4 - Ischemic rest pain, 5 - Minor tissue loss, 6 - Ulceration or gangrene.

Time frame:
Baseline, 30-days
Reported as:
Mean · RCC Scores on a scale
Rutherford Clinical Classification (RCC) Assessment
RCC Scores on a scaleFull Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Mean change in RCC Score-2.14 ± 0.17
Mean RCC Score at Baseline3.40 ± 0.09
Mean RCC Score at 30-Days1.25 ± 0.20
Post-hocPost-CTO-Crossing Track Dimensions: Width

Angiographic images were post-processed and analyzed to demonstrate angiographic visibility of intraplaque channel formation and to quantify the track width.

Time frame:
Procedure, evaluated directly after performing the investigational procedure
Reported as:
Mean · mm
Post-CTO-Crossing Track Dimensions: Width
mmFull Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Post-CTO-Crossing Track Dimensions: Width2.87 ± 0.74
Post-hocPost-CTO-Crossing Track Dimensions: Diameter

Intravascular Ultrasounds (IVUS) images were post-processed and analyzed to demonstrate IVUS-confirmation of intraplaque channel formation and to quantify the track diameter.

Time frame:
Procedure, evaluated directly after performing the investigational procedure
Reported as:
Mean · mm
Post-CTO-Crossing Track Dimensions: Diameter
mmFull Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Post-CTO-Crossing Track Dimensions: Diameter2.78 ± 0.73
Post-hocPost-CTO-Crossing Track Dimensions: Cross Sectional Area

Intravascular Ultrasounds (IVUS) images were post-processed and analyzed to demonstrate IVUS-confirmation of intraplaque channel formation, and to quantify the track dimensions.

Time frame:
Procedure, evaluated directly after performing the investigational procedure
Reported as:
Mean · mm^2
Post-CTO-Crossing Track Dimensions: Cross Sectional Area
mm^2Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Post-CTO-Crossing Track Dimensions: Cross Sectional Area6.71 ± 3.7
Other pre-specifiedPain Numeric Rating Scale (NRS) Assessment

The mean change in Pain Numeric Rating Scale (NRS) assessment at 30-days versus baseline. The Pain Numeric Rating Scale (Pain NRS) is a unidimensional measure of pain intensity in adults. The NRS is anchored by terms describing pain severity extremes, where 0 represents no pain and 10 represents the worst pain possible. The NRS Ratings and associated Clinical Descriptions are as follows: 0 - No Pain, 1-3 - Mild Pain, 4-6 - Moderate Pain, 7-9 - Severe Pain, 10 - Worst Pain Possible.

Time frame:
Baseline, 30-days
Reported as:
Mean · Pain NRS Scores on a scale
Pain Numeric Rating Scale (NRS) Assessment
Pain NRS Scores on a scaleFull Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Mean change in Pain NRS Rating-3.17 ± 0.39
Mean Pain NRS Rating at Baseline5.24 ± 0.36
Mean Pain NRS Rating at 30-days2.06 ± 0.33

Adverse events

Collected over 30-days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Study Participants1/79 (1.3%)5/79 (6.3%)39/79 (49.4%)
Most frequent serious events
Most frequent serious events
EventAll Study Participants
Ansel sheath complicationSurgical and medical procedures1/79
AnemiaBlood and lymphatic system disorders1/79
Balloon failureSurgical and medical procedures1/79
DeathGeneral disorders1/79
HypertensionCardiac disorders1/79
InfectionInfections and infestations1/79
PainGeneral disorders1/79
PseudoaneurysmSurgical and medical procedures1/79
Most frequent other events
Showing 10 of 18
Most frequent other events
EventAll Study Participants
Arterial dissectionSurgical and medical procedures12/79
PainGeneral disorders8/79
EdemaGeneral disorders7/79
Arterial perforationSurgical and medical procedures4/79
BradycardiaCardiac disorders2/79
Rutherford DeclinesGeneral disorders2/79
HypertensionCardiac disorders2/79
InfectionInfections and infestations2/79
Acute digital ischemiaGeneral disorders1/79
Arterial blushVascular disorders1/79

Baseline characteristics

The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version. The FAS population is the primary analysis population defined in the Study Protocol and is the only population with reported Baseline Characteristics analysis as pre-specified in the study Statistical Analysis Plan (SAP).

Age, Continuous
Age, Continuous(years)Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Mean69.4 ± 9.02
Sex: Female, Male
Sex: Female, Male(Participants)Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Female26
Male48
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Black, non-Hispanic8
Hispanic3
Other, non-Hispanic1
White, non-Hispanic61
Missing1
Region of Enrollment
Region of Enrollment(participants)Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
United States74
Arterial Access Type
Arterial Access Type(Participants)Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
Primary Access — Retrograde Femoral62
Primary Access — Antegrade Femoral12
Primary Access — Pedal0
Primary Access — Popliteal0
Secondary Access — Retrograde Femoral1
Secondary Access — Antegrade Femoral2
Secondary Access — Pedal9
Secondary Access — Popliteal0
08

Study locations

18 sites
  • Dignity Health - Chandler Regional Medical Center
    Chandler, Arizona 85224, United States
  • Adventist Health St. Helena
    St. Helena, California 94754, United States
  • Vascular Care Connecticut
    Darien, Connecticut 06820, United States
  • Palm Vascular Centers
    Miami Beach, Florida 33140, United States
  • Coastal Vascular & Interventional, PLLC
    Pensacola, Florida 32504, United States
  • Piedmont Heart Institute
    Atlanta, Georgia 30309, United States
  • Midwest Cardiovascular Research Foundation
    Davenport, Iowa 52801, United States
  • Cardiovascular Institute of the South
    Houma, Louisiana 70360, United States
  • Vascular Care Group
    Wellesley, Massachusetts 06820, United States
  • Saint Luke's Hospital of Kansas City
    Kansas City, Missouri 64111, United States
  • Mercy Hospital South
    St Louis, Missouri 63128, United States
  • American Endovascular & Amputation Prevention
    West Orange, New Jersey 07052, United States
  • Vascular Solutions of North Carolina
    Cary, North Carolina 27518, United States
  • The Miriam Hospital
    Providence, Rhode Island 02906, United States
  • Wellmont Cardiology Services
    Kingsport, Tennessee 37660, United States
  • VA North Texas Medical Center
    Dallas, Texas 75216, United States
  • Baylor Scott & White, The Heart Hospital Plano
    Plano, Texas 75093, United States
  • Cardiovascular Associated of East Texas
    Tyler, Texas 75701, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 22, 2025

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

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04663867
Lead sponsor
AngioSafe, Inc.
Collaborators
Veranex, Inc.
Responsible party
Sponsor
First posted
Dec 11, 2020
Start date
Feb 3, 2021
Primary completion
Apr 25, 2023
Completion
Jun 15, 2023
Results posted
Feb 12, 2026
Last update
Feb 12, 2026

Study contacts

Subhash Banerjee, MD
principal investigator · North Texas Veterans Healthcare System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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