JetStream Atherectomy for the Treatment of In-stent Restenosis

Completed · Not applicable

Conditions studied: Femoropopliteal In-stent Restenosis

In brief

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.

Key facts

Study ID: NCT02730234
Run by: Midwest Cardiovascular Research Foundation
People needed: 60
Starts: 2016-04-01
Expected to finish: 2020-09-24
Last updated by the study team: 2021-08-11

Who can join

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

You may qualify if…

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.
There is no exclusion based on how the prior treatment was done including if drug eluting balloons or stents have been used. Covered stents cannot be included
There is no limit on the length of the target lesion as long as only one target lesion is treated and enrolled

You may not qualify if…

Subjects must meet all of the following criteria to be eligible to participate in this study:
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.
The main target vessel reference diameter must be > or = 5 mm and ≤ 7 mm
One patent distal run-off vessel with <70% disease and with brisk flow is required.
Intraluminal crossing of the lesion. If this is not certain, IVUS may be used to verify this per operator's discretion
Patient has signed approved informed consent.
Patient is willing to comply with the follow-up evaluations at specified times.

Where it is running

Eastern Colorado Healthcare System — Denver, Colorado, United States
Florida Hospital Heartland Medical Center — Sebring, Florida, United States
Advocate Health — Downers Grove, Illinois, United States
Midwest Cardiovascular Research Foundation/Trinity Medical Center — Bettendorf, Iowa, United States
Midwest Cardiovascular Research Foundation/Genesis Medical Center — Davenport, Iowa, United States
Endovascular Technologies, LLC — Shreveport, Louisiana, United States
Atlantic Medical Imaging — Galloway, New Jersey, United States
New Mexico Heart Institute — Albuquerque, New Mexico, United States
Promedica Toledo Hospital — Toledo, Ohio, United States
University of Oklahoma Health Science Center — Oklahoma City, Oklahoma, United States
US Departmetn of Veterans Affairs, Oklahoma VA Medical Center — Oklahoma City, Oklahoma, United States
Medical University of South Carolina — Charleston, South Carolina, United States
VA North Texas Health Care System: Dallas VA Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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