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NCT02730234 · ClinicalTrials.gov registry record · NA
JetStream Atherectomy for the Treatment of In-stent Restenosis
A NA study, sponsored by Midwest Cardiovascular Research Foundation.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT02730234 is a NA study that has completed, run by Midwest Cardiovascular Research Foundation. The registered enrollment target is 60 participants.
The verdict
NCT02730234, a NA study, has completed, sponsored by Midwest Cardiovascular Research Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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.
Interventions
- DEVICE JetStream XC with balloon angioplasty
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2016-04 |
| Est. Completion | 2020-09-24 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02730234
The ClinicalTrials.gov registry entry for NCT02730234 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Midwest Cardiovascular Research Foundation, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which JetStream XC with balloon angioplasty is the first listed.
NCT02730234 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02730234 about?
NCT02730234 is a clinical study titled "JetStream Atherectomy for the Treatment of In-stent Restenosis". 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 ...
What is the current status of trial NCT02730234?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2016-04. Estimated completion is 2020-09-24.
What interventions are being tested in trial NCT02730234?
The interventions under investigation include: JetStream XC with balloon angioplasty (DEVICE).
Who is sponsoring clinical trial NCT02730234?
This trial is sponsored by Midwest Cardiovascular Research Foundation, which has 5 total clinical trials registered on ClinicalTrials.gov.
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