At a glance
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JetStream Atherectomy for the Treatment of In-stent Restenosis of the Femoropopliteal Artery
In Brief
A clinical study evaluating JetStream XC with balloon angioplasty for Femoropopliteal In-stent Restenosis. Completed, enrolled 60 participants across 13 sites.
Detailed Summary
The purpose of this study is to test the hypothesis that Jetstream atherectomy (JS) and adjunctive balloon angioplasty (PTA) (JS +PTA) improves target lesion revascularization (TLR) at 6 months follow-up when compared to historic data from PTA alone in the treatment of femoropopliteal (FP) arterial In-stent restenotic (ISR) disease. This is a prospective, multicenter, single arm study evaluating the investigational use of Jetstream Atherectomy (JS) and adjunctive balloon angioplasty (JS +PTA) in the treatment of FP ISR lesions in subjects with claudication or limb ischemia (Rutherford clinical category (RCC) of 2-4) (lesion length ≥ 4 cm). The comparator arm is historic data from plain old balloon angioplasty derived from a Meta-analysis of the 3 published randomized trials in the field.
Study Details
Timeline
Interventions
JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.