Evaluation of the Pantheris Atherectomy System

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT01937351

Run by

Avinger, Inc.

People needed

162

Starts

2013-06-25

Expected to finish

2015-09-20

Last updated by the study team

2021-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

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

Full record on ClinicalTrials.gov

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