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NCT01722877 · ClinicalTrials.gov registry record · NA
JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions
A NA study of Peripheral Vascular Disease and Restenosis, sponsored by Midwest Cardiovascular Research Foundation.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
- 2
- Study locations
NCT01722877: Completed NA study of Peripheral Vascular Disease and Restenosis, sponsored by Midwest Cardiovascular Research Foundation.
NCT01722877 is a NA study of Peripheral Vascular Disease and Restenosis that has completed, run by Midwest Cardiovascular Research Foundation. The registered enrollment target is 29 participants, below the 281-participant average among 25 other Peripheral Vascular Disease trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01722877, a NA study of Peripheral Vascular Disease and Restenosis, has completed, sponsored by Midwest Cardiovascular Research Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
- 2
- Study locations
Study Summary
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Treatment of these in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue is frequently seen. Several methods have been proposed to treat in-stent restenosis in the lower leg arteries but mixed results have been noted. In this study we hypothesize that simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can lead to a high rate of acute procedural success with low intraprocedural complications and an acceptable recurrence rate of restenosis at 6-month follow-up.
Primary Outcome
Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.
Conditions Studied
Interventions
- DEVICE JetStream Navitus
Study Locations (2)
Iowa
- Trinity Bettendorf Medical Center - Bettendorf
Texas
- VA Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2012-10 |
| Est. Completion | 2015-09 |
| Phase | NA |
What the finished NCT01722877 record still lists
NCT01722877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 281-participant average among 25 other Peripheral Vascular Disease trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Peripheral Vascular Disease appearing as the primary indexed condition, and to 1 intervention - of which JetStream Navitus is the first listed.
NCT01722877 reports a single indexed study location in Iowa, Texas.
Frequently Asked Questions
What is clinical trial NCT01722877 about?
NCT01722877 is a clinical study titled "JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions". Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Treatment of these in-stent restenotic lesions ha...
What is the current status of trial NCT01722877?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2012-10. Estimated completion is 2015-09.
What conditions does trial NCT01722877 study?
This clinical trial studies the following conditions: Peripheral Vascular Disease, Restenosis.
What interventions are being tested in trial NCT01722877?
The interventions under investigation include: JetStream Navitus (DEVICE).
Who is sponsoring clinical trial NCT01722877?
This trial is sponsored by Midwest Cardiovascular Research Foundation, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01722877 being conducted?
This trial has 2 study locations across Iowa, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01722877's enrollment target sits among peer trials
29 22nd of 25 higher than 4 of 25 other Peripheral Vascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Vascular Disease 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.
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