Randomized Controlled Trial of the Auryon Atherectomy System Used in Combination With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia
Angiodynamics, Inc.
Summary
The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages. The main question it aims to answer is: Is treatment with Auryon Atherectomy System more effective than angioplasty alone in preventing death, amputation, revascularization and improving patency? Researchers will compare the Auryon Atherectomy System with balloon angioplasty to balloon angioplasty alone.
Description
Up to 1500 subjects who do not meet the inclusion/exclusion criteria for the randomized study may satisfy the eligibility criteria for, and be enrolled in, the observational study.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age of subject is ≥ 18. * Estimated life expectancy ≥1 year. * Subject is able and willing to comply with all assessments in the study. * Subject has been informed of the nature of the study, agrees to participate, and has signed the approved consent form. * Rutherford Category classification of 4 or 5 of the target limb. * Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guidelines. Angiographic Inclusion Criteria * Target lesion that is located in a native, de novo infra-popliteal artery…
Interventions
- DeviceAuryon Atherectomy System
Auryon Atherectomy System is composed of a laser and catheter
- DeviceBalloon Angioplasty
Balloon Angioplasty alone
Locations (9)
- Abrazo Arizona Heart HospitalPhoenix, Arizona
- Kaiser PermanenteSan Diego, California
- CIS Grey ASCGray, Louisiana
- MedStar Health Research InstituteBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- The Washington UniversitySt Louis, Missouri