A Prospectice, Multicenter, Randomized Study Evaluating the Use of Jetstream Atherectomy (JS) Followed by DCB in Comparison to the Use of Plain Old Balloon Angioplasty (POBA) Followed by DCB Alone in the Treatment of Complex Lesions

Grants and Contracts Details

Description

HUMAN CLINICAL TRIAL The purpose of this study is to test the hypothesis that Jetstream atherectomy followed by Ranger or IN.PACT Paclitaxel Drug Coated Balloon (DCB) improves target lesion revascularization at 1 year follow-up when compared to balloon angioplasty followed by Ranger or IN.PACT in the treatment of femoropopliteal arterial denovo disease. A prospective, multicenter, randomized study evaluating the use of Jetstream Atherectomy (JS) followed by DCB in comparison to the use of balloon angioplasty (PTA) followed by DCB alone in the treatment of complex lesions in femoropopliteal arteries in subjects with claudication (Rutherford Clinical Category (RCC) of 2-4) (complex lesions are defined as long (. 10 cm) lesions, or moderately or highly calcified lesions, or chronic total occlusions irrespective of length)
StatusFinished
Effective start/end date7/2/192/4/20

Funding

  • Midwest Cardiovascular Research Foundation: $8,702.00

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