Evaluation of the Pantheris Atherectomy System

Peripheral Arterial Disease Clinical Trial

— VISION  

Official title:

Evaluation of the Pantheris Optical Coherence Tomography Imaging Atherectomy System for Use in the Peripheral Vasculature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937351
• Other study ID #: P0555
• Status: Completed
• Phase: N/A
• Start date: June 25, 2013
• Est. completion date: September 20, 2015

Study information

• Verified date: March 2021
• Source: Avinger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: September 20, 2015
• Est. primary completion date: July 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	Muenster Hospital	Muenster
United States	Austin Heart	Austin	Texas
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	Hatton Institute for Research and Education, Good Samaritan Hospital - Bethesda North	Cincinnati	Ohio
United States	Dayton Heart Center/Good Samaritan Hospital	Dayton	Ohio
United States	Detroit Medical Center Cardiovascular Institute Harper-Hutzel Hospital	Detroit	Michigan
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	Alexian Brothers Medical Center, Cardiovascular Associates	Elk Grove Village	Illinois
United States	St. Joseph's Hospital	Fort Wayne	Indiana
United States	St. Dominic Hospital	Jackson	Mississippi
United States	St. Bernard's Medical Center	Jonesboro	Arkansas
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Methodist Hospital	Memphis	Tennessee
United States	St. Peters University Hospital	New Brunswick	New Jersey
United States	Advocate Christ Hospital and Medical Center	Oak Lawn	Illinois
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Coastal Vascular and Interventional	Pensacola	Florida
United States	Einstein Medical Center	Philadelphia	Pennsylvania
United States	Jobst Vascular Center	Toledo	Ohio
United States	Medstar Washington Hospital	Washington	District of Columbia
United States	Cedars Sinai Medical Center/Cardiovascular Research Foundation of Southern California	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
Avinger, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Cardiovascular related death; Unplanned, major index limb amputation; Clinically driven target lesion revascularization (TLR); Myocardial infarction; Device related events: Clinically significant perforation; Clinically significant dissection; Clinically significant embolus; Pseudoaneurysm	Day 0 through 6 Months
Primary	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.	Day 0
Secondary	Secondary Safety Endpoint	Freedom from MAEs as defined above, through 30 days (or hospital discharge, whichever is longer) as adjudicated by an independent CEC.	Day 0 through Day 30
Secondary	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.	Day 0 through 30 days
Secondary	Secondary Safety Endpoint	Freedom from clinically driven Target Vessel Revascularization (TVR) through 6 months, as adjudicated by an independent CEC.	Day 0 through 6 Months
Secondary	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.	Day 0
Secondary	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).	Day 30
Secondary	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.	Day 30
Secondary	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).	Day 30
Secondary	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.	Day 30
Secondary	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).	6 Month
Secondary	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.	6 Month
Secondary	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).	6 Month
Secondary	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.	6 Month