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NCT03192696 · ClinicalTrials.gov registry record · NA
Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries
A NA study, sponsored by Avinger.
- Completed
- Registry status
- NA
- Development phase
- 127
- Enrollment target
NCT03192696: Completed NA study, sponsored by Avinger.
NCT03192696 is a NA study that has completed, run by Avinger. The registered enrollment target is 127 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03192696, a NA study, has completed, sponsored by Avinger.
- COMPLETED
- Registry status
- NA
- Development phase
- 127 participants
- Enrollment target
Study Summary
A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.
Primary Outcome
The primary safety endpoint is freedom from a composite of major adverse events (MAEs) through 30-day follow-up, as adjudicated by an independent CEC. Individual MAEs include: 1. Cardiovascular-related death; 2. Unplanned, major index limb amputation; 3. Clinically driven target lesion revascularization (TLR); 4. Myocardial infarction; or 5. Device-associated events: 1. Clinically significant perforation, 2. Clinically significant dissection, 3. Clinically significant embolus, or
Interventions
- DEVICE Atherectomy Catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2017-10-19 |
| Est. Completion | 2021-12-01 |
| Phase | NA |
What the finished NCT03192696 record still lists
NCT03192696 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Atherectomy Catheter is the first listed.
NCT03192696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03192696 about?
NCT03192696 is a clinical study titled "Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries". A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.
What is the current status of trial NCT03192696?
This trial is currently completed. It is a NA study. The enrollment target is 127 participants. The study started on 2017-10-19. Estimated completion is 2021-12-01.
What interventions are being tested in trial NCT03192696?
The interventions under investigation include: Atherectomy Catheter (DEVICE).
Who is sponsoring clinical trial NCT03192696?
This trial is sponsored by Avinger, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03192696's enrollment target sits among peer trials
127 749th of 2000 higher than 1,252 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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