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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: Completed NA study, sponsored by Midwest Cardiovascular Research Foundation.
NCT02730234 is a NA study that has completed, run by Midwest Cardiovascular Research Foundation. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 6 months. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis)
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 |
What the finished NCT02730234 record still lists
NCT02730234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which JetStream XC with balloon angioplasty is the first listed.
NCT02730234 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02730234's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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