CompletedNCT01937351VISIONUpdated Mar 25, 2021Results posted

Evaluation of the Pantheris Atherectomy System

An interventional study of Pantheris System in Peripheral Arterial Disease, sponsored by Avinger, Inc.. Completed at 21 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-25.

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

Phase: Not applicable
Study type: Interventional
Enrollment: 162
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries.

Read the detailed description

The trial will enroll up to 173 subjects diagnosed with peripheral arterial disease of the lower extremities at up to 20 sites (up to 3 international sites), including 133 Intention to Treat subjects and up to 2 additional Roll-In subjects at each site (up to 40 Roll-In subjects total). The primary disease must be located in reference vessel diameters ≥ 2.5 mm and ≤ 7.0 mm. Trial success is focused on safety including rates of major adverse events through 6 months as adjudicated by a Clinical Events Committee. Effectiveness will be evaluated using technical success, defined as the percent of target lesions that have a residual diameter stenosis \<50% post-treatment with the Pantheris device alone as assessed by Angiographic Core Lab.

Conditions studied

Peripheral Arterial Disease

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Keywords

Atherectomy
Optical Coherence Tomography
Lumivascular

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria:

Age ≥ 18 years old;
Subject is a candidate for percutaneous intervention for peripheral arterial disease in the legs;
Subject is willing and able to give informed consent;
Documented symptomatic atherosclerotic peripheral arterial disease Rutherford Classification 2-5;
Reference vessel lumen proximal to target lesion ≥ 2.5 mm and ≤ 7.0 mm in diameter by visual estimation;
Subject has de novo target lesion(s) with stenosis >70% by visual estimation distal to the profunda femoral artery. No more than 2 lesions may be treated with the Pantheris device;
Target lesion length ≤ 15 cm (may be two tandem lesions that do not exceed 15cm in total length);
Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days and 6 months;
At least one patent tibial run-off vessel at baseline.

Inclusion Criteria for the 24-month follow up:

Completed the 6-month follow-up visit
Re-consented prior to the 24-month follow-up visit

Exclusion Criteria:

Subject is pregnant or breast feeding;
Rutherford Class 0 to 1 (asymptomatic and mild claudication);
Rutherford Class 6 (critical limb ischemia);
Moderate to severe calcification of the target lesion;
Acute ischemia and/or acute thrombosis of the Superficial Femoral Artery (SFA)-Popliteal segment;
In-stent restenosis within the target lesion;
Target lesion with any type of stent or graft;
Target lesion in the iliac artery;
Target lesion stenosis \<70%;
Subjects with significant (≥70%) occlusive lesions proximal to the target lesion not successfully treated during the index procedure (upstream disease) and prior to treatment of the target lesion;
Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure;
Planned endovascular or surgical procedure 30 days after the index procedure;
Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure;
Subjects with active systemic infections whether they are being currently treated or not;
Subjects on chronic hemodialysis or creatinine level >2.0mg/dL;
Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months;
Evidence or history of aneurysmal target vessel within the past 2 months;
History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days;
Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated;
Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated;
History of heparin-induced thrombocytopenia (HIT);
Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/mm2, known coagulopathy, or International Normalized Ratio (INR) >1.5;
Any thrombolytic therapy within 2 weeks of the index procedure;
Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the study device into the subject;
Subjects or their legal guardians who have not or will not sign the Informed Consent;
Subjects who are unwilling or unable to comply with the follow-up study requirements;
Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 162 participants (actual)

Study arms

Experimental
Pantheris Treatment Arm
Intervention: Atherectomy using the Pantheris system.
Device: Pantheris System

Interventions

DevicePantheris System
Atherectomy using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries.

What researchers measure

Primary outcomes

Primary Safety Endpoint
The primary safety endpoint is defined as freedom from a composite of major adverse events (MAE) through 6-Month follow-up as adjudicated by an independent Clinical Events Committee (CEC). Individual MAEs include: 1. Cardiovascular related death 2. Unplanned, major index limb amputation 3. Clinically driven target lesion revascularization (TLR) 4. Myocardial infarction 5. Device related events: 1. Clinically significant perforation 2. Clinically significant dissection 3. Clinically significant embolus 4. Pseudoaneurysm
Time frame: Day 0 through 6 Months
Primary Effectiveness Endpoint: Technical Success
The primary efficacy endpoint of technical success is defined as the percent of target lesions that have a residual diameter stenosis \<50% post the Pantheris device alone, as assessed by an independent Angiographic Core Laboratory.
Time frame: Day 0

Secondary outcomes

Secondary Safety Endpoint
Freedom from MAEs as defined above, through 30 days (or hospital discharge, whichever is longer) as adjudicated by an independent CEC.
Time frame: Day 0 through Day 30
Secondary Safety Endpoint
Freedom from procedural emboli, defined as a change in any visualized runoff vessel (other than vasospasm and dissection) at any time during the procedure.
Time frame: Day 0 through 30 days
Secondary Safety Endpoint
Freedom from clinically driven Target Vessel Revascularization (TVR) through 6 months, as adjudicated by an independent CEC.
Time frame: Day 0 through 6 Months
Secondary Effectiveness Endpoint: Procedural Success
Procedural success defined as the percent of target lesions that have residual diameter stenosis \< 30% post-Pantheris and any other adjunctive therapy, determined by independent Angiographic Core Laboratory.
Time frame: Day 0
Secondary Effectiveness Endpoint: ABI
Ankle-Brachial Index (ABI) at 30 days. ABI is the ratio of blood pressure in the lower legs to the blood pressure in the arms. ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease).
Time frame: Day 30
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification at 30 days. Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: asymptomatic, to Class 6: major tissue loss.
Time frame: Day 30
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Change in Quality of Life measures between Baseline and 30 days using 12-Item Short Form Survey (SF-12). There are two components of the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).
Time frame: Day 30
Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
Change in Quality of Life measures between Baseline and 30 days using Vascular Quality of Life Questionnaire (VascuQoL). The VascuQoL is a disease-specific questionnaire developed to assess chronic limb ischemia. VascuQol uses a seven-point scale, with 1 representing the worst score and 7 representing the best score.
Time frame: Day 30
Secondary Effectiveness Endpoint: ABI
Ankle-Brachial Index (ABI) at 6 months. ABI is the ratio of blood pressure in the lower legs to the blood pressure in the arms. ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease).
Time frame: 6 Month
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification at 6 months. Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: asymptomatic, to Class 6: major tissue loss.
Time frame: 6 Month
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Change in Quality of Life measures between Baseline and 6 Months using 12-Item Short Form Survey (SF-12). There are two components of the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).
Time frame: 6 Month
Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
Change in Quality of Life measures between Baseline and 6 months using Vascular Quality of Life Questionnaire (VascuQoL). The VascuQoL is a disease-specific questionnaire developed to assess chronic limb ischemia. VascuQol uses a seven-point scale, with 1 representing the worst score and 7 representing the best score.
Time frame: 6 Month

Results

Posted May 12, 2017

Participant flow

Participant flow — Overall Study
Milestone	Primary Cohort	Roll-in Cohort
Started	134	28
Treated w study device	130	28
30-day follow-up	128	27
6-month follow-up	125	26
Completed	125	26
Not completed	9	2
Withdrew: Withdrawal by subject	4	2
Withdrew: Death	1	0
Withdrew: Not treated w device, per protocol fail	4	0

Outcome measures

PrimaryPrimary Safety Endpoint

The primary safety endpoint is defined as freedom from a composite of major adverse events (MAE) through 6-Month follow-up as adjudicated by an independent Clinical Events Committee (CEC). Individual MAEs include: 1. Cardiovascular related death 2. Unplanned, major index limb amputation 3. Clinically driven target lesion revascularization (TLR) 4. Myocardial infarction 5. Device related events: 1. Clinically significant perforation 2. Clinically significant dissection 3. Clinically significant embolus 4. Pseudoaneurysm

Time frame:: Day 0 through 6 Months
Reported as:: Number · percentage of subjects

Primary Safety Endpoint
percentage of subjects	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Primary Safety Endpoint	82.4	82.4

PrimaryPrimary Effectiveness Endpoint: Technical Success

The primary efficacy endpoint of technical success is defined as the percent of target lesions that have a residual diameter stenosis \<50% post the Pantheris device alone, as assessed by an independent Angiographic Core Laboratory.

Time frame:: Day 0
Reported as:: Number · percentage of lesions

Primary Effectiveness Endpoint: Technical Success
percentage of lesions	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Primary Effectiveness Endpoint: Technical Success	96.3	94.0

SecondarySecondary Safety Endpoint

Freedom from MAEs as defined above, through 30 days (or hospital discharge, whichever is longer) as adjudicated by an independent CEC.

Time frame:: Day 0 through Day 30
Reported as:: Number · percentage of subjects

Secondary Safety Endpoint
percentage of subjects	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Secondary Safety Endpoint	93.1	93.3

SecondarySecondary Safety Endpoint

Freedom from procedural emboli, defined as a change in any visualized runoff vessel (other than vasospasm and dissection) at any time during the procedure.

Time frame:: Day 0 through 30 days
Reported as:: Number · Percentage of subjects

Secondary Safety Endpoint
Percentage of subjects	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Secondary Safety Endpoint	97.7 (93.4 to 99.5)	97.8 (93.6 to 99.5)

SecondarySecondary Safety Endpoint

Freedom from clinically driven Target Vessel Revascularization (TVR) through 6 months, as adjudicated by an independent CEC.

Time frame:: Day 0 through 6 Months
Reported as:: Number · Percentage of subjects

Secondary Safety Endpoint
Percentage of subjects	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Secondary Safety Endpoint	91.2 (84.8 to 95.5)	91.2 (84.8 to 95.5)

SecondarySecondary Effectiveness Endpoint: Procedural Success

Procedural success defined as the percent of target lesions that have residual diameter stenosis \< 30% post-Pantheris and any other adjunctive therapy, determined by independent Angiographic Core Laboratory.

Time frame:: Day 0
Reported as:: Number · percentage of lesions

Secondary Effectiveness Endpoint: Procedural Success
percentage of lesions	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Secondary Effectiveness Endpoint: Procedural Success	78.7	79.0

SecondarySecondary Effectiveness Endpoint: ABI

Ankle-Brachial Index (ABI) at 30 days. ABI is the ratio of blood pressure in the lower legs to the blood pressure in the arms. ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease).

Time frame:: Day 30
Reported as:: Mean · Index

Secondary Effectiveness Endpoint: ABI
Index	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Secondary Effectiveness Endpoint: ABI	0.95 ± 0.16	0.95 ± 0.16

SecondarySecondary Effectiveness Endpoint: Rutherford Classification

Rutherford Classification at 30 days. Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: asymptomatic, to Class 6: major tissue loss.

Time frame:: Day 30
Reported as:: Number · Percentage of subjects

Secondary Effectiveness Endpoint: Rutherford Classification
Percentage of subjects	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Rutherford Classification: 0 - Asymptomatic	52.9	52.8
Rutherford Classification: 1 - Mild Claudication	31.4	31.2
Rutherford Classification: 2 - Moderate Claudication	10.7	10.4
Rutherford Classification: 3 - Severe Claudication	4.1	4.8
Rutherford Classification: 4 - Ischemic Rest Pain	0	0
Rutherford Classification: 5 - Minor Tissue Loss	0.8	0.8
Rutherford Classification: 6 - Major Tissue Loss	0	0

SecondarySecondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)

Change in Quality of Life measures between Baseline and 30 days using 12-Item Short Form Survey (SF-12). There are two components of the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).

Time frame:: Day 30
Reported as:: Mean · Score on a scale

Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Score on a scale	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Mean SF-12 Mental Component Score: Baseline	50.0 ± 10.3	50.3 ± 10.3
Mean SF-12 Mental Component Score: 30-Day	52.1 ± 9.3	52.4 ± 9.3
Mean SF-12 Physical Component Score: Baseline	35.6 ± 8.7	35.5 ± 8.6
Mean SF-12 Physical Component Score: 30-Day	41.5 ± 10.5	41.5 ± 10.4

SecondarySecondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)

Change in Quality of Life measures between Baseline and 30 days using Vascular Quality of Life Questionnaire (VascuQoL). The VascuQoL is a disease-specific questionnaire developed to assess chronic limb ischemia. VascuQol uses a seven-point scale, with 1 representing the worst score and 7 representing the best score.

Time frame:: Day 30
Reported as:: Mean · score on a scale

Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
score on a scale	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Mean VascuQoL Score at Baseline	4.1 ± 1.2	4.1 ± 1.2
Mean VascuQoL Score at 30 Days	5.4 ± 1.5	5.4 ± 1.5

SecondarySecondary Effectiveness Endpoint: ABI

Ankle-Brachial Index (ABI) at 6 months. ABI is the ratio of blood pressure in the lower legs to the blood pressure in the arms. ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease).

Time frame:: 6 Month
Reported as:: Mean · Index

Secondary Effectiveness Endpoint: ABI
Index	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Secondary Effectiveness Endpoint: ABI	0.85 ± 0.23	0.85 ± 0.23

SecondarySecondary Effectiveness Endpoint: Rutherford Classification

Rutherford Classification at 6 months. Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: asymptomatic, to Class 6: major tissue loss.

Time frame:: 6 Month
Reported as:: Number · Percentage of subjects

Secondary Effectiveness Endpoint: Rutherford Classification
Percentage of subjects	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Rutherford Classification: 0 - Asymptomatic	41.7	41.7
Rutherford Classification: 1 - Mild Claudication	29.2	29.2
Rutherford Classification: 2 - Moderate Claudication	14.2	14.2
Rutherford Classification: 3 - Severe Claudication	11.7	11.7
Rutherford Classification: 4 - Ischemic Rest Pain	1.7	1.7
Rutherford Classification: 5 - Minor Tissue Loss	1.7	1.7
Rutherford Classification: 6 - Major Tissue Loss	0	0

SecondarySecondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)

Change in Quality of Life measures between Baseline and 6 Months using 12-Item Short Form Survey (SF-12). There are two components of the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).

Time frame:: 6 Month
Reported as:: Mean · score on a scale

Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
score on a scale	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Mean SF-12 Mental Component Score: Baseline	50.0 ± 10.3	50.3 ± 10.3
Mean SF-12 Mental Component Score: 6-Month	51.0 ± 11.0	51.0 ± 11.0
Mean SF-12 Physical Component Score: Baseline	35.6 ± 8.7	35.5 ± 8.6
Mean SF-12 Physical Component Score: 6-Month	39.3 ± 9.7	39.3 ± 9.7

SecondarySecondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)

Change in Quality of Life measures between Baseline and 6 months using Vascular Quality of Life Questionnaire (VascuQoL). The VascuQoL is a disease-specific questionnaire developed to assess chronic limb ischemia. VascuQol uses a seven-point scale, with 1 representing the worst score and 7 representing the best score.

Time frame:: 6 Month
Reported as:: Mean · score on a scale

Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
score on a scale	Primary Cohort: Per Protocol	Primary Cohort: Intention-to-Treat
Mean VascuQoL Score at Baseline	4.1 ± 1.2	4.1 ± 1.2
Mean VascuQoL Score at 6 Months	5.0 ± 1.5	5.0 ± 1.5

Adverse events

Collected over All subjects between enrollment and 6 month follow-up.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Primary Cohort	5/134 (3.7%)	89/134 (66.4%)	22/22 (100%)

Most frequent serious events

Showing 10 of 73

Most frequent serious events
Event	Primary Cohort
Clinically Driven Target Lesion RevascularizationVascular disorders	10/134
Vessel dissection, Grade A or BSurgical and medical procedures	4/134
Myocardial InfarctionCardiac disorders	3/134
Access Site ComplicationSurgical and medical procedures	3/134
Bleeding (other than access site)Injury, poisoning and procedural complications	3/134
Pain, new onset or worsening from baselineVascular disorders	3/134
Emboli requiring intervention to resolve acutelyVascular disorders	3/134
Vessel dissection, Grade C or greaterVascular disorders	3/134
Clinically Driven Target Vessel RevascularizationVascular disorders	2/134
Pseudoaneurysm defined as device related disruption of the arterial wallVascular disorders	2/134

Most frequent other events

Most frequent other events
Event	Primary Cohort
Pain, New Onset or Worsening from BaselineGeneral disorders	14/22
Access Site ComplicationSurgical and medical procedures	8/22

Baseline characteristics

The study consisted of Roll-In Cohort and a Primary Analysis Cohort. Up to 2 Roll-In subjects could be treated at each study site prior to initiation of enrollment in the Primary Analysis Cohort.Roll-In subjects were designed to provide the Investigator an opportunity to gain experience with the Pantheris System for learning curve purposes.

Age, Continuous
Age, Continuous(years)	Primary Cohort	Roll-In Cohort	Total
Mean	67.4 ± 10.5	66.7 ± 10.5	67.3 ± 10.5

Sex: Female, Male
Sex: Female, Male(Participants)	Primary Cohort	Roll-In Cohort	Total
Female	58	13	71
Male	76	15	91

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Primary Cohort	Roll-In Cohort	Total
Caucasian	80	20	100
African American	35	8	43
Hispanic or Latino	8	0	8
Asian	1	0	1
Other	1	0	1
Unknown or Unavailable	9	0	9

Region of Enrollment
Region of Enrollment(participants)	Primary Cohort	Roll-In Cohort	Total
United States	127	28	155
Germany	7	0	7

Weight
Weight(pounds)	Primary Cohort	Roll-In Cohort	Total
Mean	179.5 ± 43.0	199.3 ± 45.3	182.9 ± 44.0

Height
Height(inches)	Primary Cohort	Roll-In Cohort	Total
Mean	66.8 ± 3.8	66.5 ± 4.1	66.7 ± 3.8

Study locations

21 sites

St. Bernard's Medical Center
Jonesboro, Arkansas 72401, United States
Arkansas Heart Hospital
Little Rock, Arkansas 72211, United States
Cedars Sinai Medical Center/Cardiovascular Research Foundation of Southern California
West Hollywood, California 90048, United States
Medstar Washington Hospital
Washington, District of Columbia 20010, United States
Coastal Vascular and Interventional
Pensacola, Florida 32501, United States
Alexian Brothers Medical Center, Cardiovascular Associates
Elk Grove Village, Illinois 60007, United States
Advocate Christ Hospital and Medical Center
Oak Lawn, Illinois 60453, United States
St. Joseph's Hospital
Fort Wayne, Indiana 46802, United States
Detroit Medical Center Cardiovascular Institute Harper-Hutzel Hospital
Detroit, Michigan 48201, United States
St. John Hospital and Medical Center
Detroit, Michigan 48236, United States
St. Dominic Hospital
Jackson, Mississippi 39216, United States
University of Nebraska Medical Center
Omaha, Nebraska 68198, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey 08015, United States
St. Peters University Hospital
New Brunswick, New Jersey 08901, United States
Hatton Institute for Research and Education, Good Samaritan Hospital - Bethesda North
Cincinnati, Ohio 45220, United States
Dayton Heart Center/Good Samaritan Hospital
Dayton, Ohio 45414, United States
Jobst Vascular Center
Toledo, Ohio 43606, United States
Einstein Medical Center
Philadelphia, Pennsylvania 19141, United States
Methodist Hospital
Memphis, Tennessee 38116, United States
Austin Heart
Austin, Texas 78756, United States
Muenster Hospital
Muenster, 48145, Germany

References and documents

Publications

Schwindt AG, Bennett JG Jr, Crowder WH, Dohad S, Janzer SF, George JC, Tedder B, Davis TP, Cawich IM, Gammon RS, Muck PE, Pigott JP, Dishmon DA, Lopez LA, Golzar JA, Chamberlin JR, Moulton MJ, Zakir RM, Kaki AK, Fishbein GJ, McDaniel HB, Hezi-Yamit A, Simpson JB, Desai A. Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study. J Endovasc Ther. 2017 Jun;24(3):355-366. doi: 10.1177/1526602817701720. Epub 2017 Apr 10. PubMed 28393673 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT01937351
Lead sponsor: Avinger, Inc.
Responsible party: Sponsor
First posted: Sep 9, 2013
Start date: Jun 25, 2013
Primary completion: Jul 15, 2015
Completion: Sep 20, 2015
Results posted: May 12, 2017
Last update: Mar 25, 2021

Study contacts

Gray Bennett, MD

principal investigator · Jackson Heart Clinic

Billy Crowder, MD

principal investigator · Jackson Heart Clinic

Arne Schwindt, MD

principal investigator · Muenster Hospital

Oversight

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

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