JetStream Atherectomy for the Treatment of In-stent Restenosis (NCT02730234) | Clinical Trial Compass
CompletedNot Applicable
JetStream Atherectomy for the Treatment of In-stent Restenosis
United States60 participantsStarted 2016-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with symptomatic peripheral arterial disease (Rutherford Becker Class II to IV)
✓. Previously treated with stenting in the femoropopliteal segment
✓. No limit on how many times the target in-stent restenotic lesion has been previously treated.
Exclusion criteria
✕. There is no limit on the length of the target lesion as long as only one target lesion is treated and enrolled
✕. Subject is 18 years of age or older.
✕. Subject presents with clinical evidence of peripheral arterial disease with ISR in the femoropopliteal segment (includes common femoral, superficial femoral and popliteal)
✕. Subject presents with a Rutherford Classification of 2-4 and has symptoms of rest limb pain or claudication.
✕. Target lesion(s) must be viewed angiographically and have ≥50% stenosis.
✕. The atherectomy wire must be placed entirely across all lesions to be treated with no visible evidence of clear or suspected subintimal/substent wire passage.
What they're measuring
1
Percentage of Participants With Target Lesion Revascularization (TLR)