Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.

Key facts

Study ID

NCT03192696

Run by

Avinger, Inc.

People needed

127

Starts

2017-10-19

Expected to finish

2021-12-01

Last updated by the study team

2023-03-28

Who can join

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

You may qualify if…

• Subject is >18 years old;
• Subject is willing and able to give informed consent;
• Subject has Rutherford Classification of I-V;
• Subject presenting with a single Class I, II or III ISR lesion as per Tosaka's Classification criteria in the lower leg extremities;
• Target lesion must be >70% stenosed and within a stented segment by angiographic visual estimation;
• Reference vessel lumen acceptable for treatment with Pantheris catheter size as per visual angiographic estimation;
• Target lesions must be within the stented segment and no more than 3 cm past the proximal or distal portions of the stent;
• Target lesion is ≤30 cm in length;
• Intraluminal crossing of totally occluded lesions prior to atherectomy;
• At least one patent tibial run-off vessel at baseline; and
• Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days, 6 months and 12 months.

You may not qualify if…

• Subject is pregnant or breast feeding;
• Rutherford Class 0 or VI;
• Severe calcification of the target lesion;
• Acute ischemia and/or acute thrombosis of the target lesion segment;
• Target lesion with a covered stent;
• Target lesion in the iliac artery;
• Target lesion stenosis <70%;
• Target lesion >30 cm in length;
• Subjects with totally occluded stented segments that are not successfully crossed intraluminally prior to atherectomy treatment;
• Grade 4 or 5 stent fracture affecting target stent, or where evidence of stent protrusion into the lumen is noted on angiography in two orthogonal views;
• Subjects on chronic hemodialysis or creatinine level >2.5 mg/dL;
• CVA or stroke within 60 days prior to the index procedure;
• 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;
• Known allergy to contrast agents or medications used to perform endovascular
• intervention that cannot be adequately pre-treated;
• Subjects in whom anti-platelet, aspirin, anticoagulant, or thrombolytic therapy is contraindicated;
• 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 during the index procedure;
• 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; or
• 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.

Where it is running

• St. Bernards Medical Center — Jonesboro, Arkansas, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• University of California San Diego (UCSD) — San Diego, California, United States
• Advocate Christ Hospital and Medical Center — Oak Lawn, Illinois, United States
• Baton Rouge General Medical Center — Baton Rouge, Louisiana, United States
• University of Missouri — Columbia, Missouri, United States
• Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
• TriHealth-Hatton Research Institute — Cincinnati, Ohio, United States
• Dayton Heart Center — Dayton, Ohio, United States
• Einstein Medical Center — Philadelphia, Pennsylvania, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States
• Cardiovascular Associates of East Texas — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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