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NCT02961894 · ClinicalTrials.gov registry record · NA
Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization
A NA study, sponsored by Rex Medical.
- Completed
- Registry status
- NA
- Development phase
- 121
- Enrollment target
NCT02961894: Completed NA study, sponsored by Rex Medical.
NCT02961894 is a NA study that has completed, run by Rex Medical. The registered enrollment target is 121 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
NCT02961894, a NA study, has completed, sponsored by Rex Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 121 participants
- Enrollment target
Study Summary
To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease. This Atherectomy system will be used on eligible patients with stenosis of at least 70% diameter reduction to evaluate the change in stenosis after the procedure (effectiveness) and the presence of any major adverse events (safety) for up to 30 days after the procedure.
Primary Outcome
Freedom from Major Adverse Events is defined as the composite of all-cause mortality, clinically-driven target lesion revascularization (TLR), major target limb amputation, major target vessel perforation requiring surgical or endovascular repair, and clinically-significant distal embolization in the target limb; as adjudicated by an independent Clinical Events Committee The primary safety endpoint is freedom from 30-day Major Adverse Events (MAE), defined as the composite of all-cause mortality
Interventions
- DEVICE Revolution™ Peripheral Atherectomy System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2017-06-07 |
| Est. Completion | 2019-09-20 |
| Phase | NA |
What the finished NCT02961894 record still lists
NCT02961894 is an interventional study that assigns participants to a tested intervention. The registered 121 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 Revolution™ Peripheral Atherectomy System is the first listed.
NCT02961894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02961894 about?
NCT02961894 is a clinical study titled "Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization". To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease. This Atherectomy system will be used on eligible patients with stenosis of at least 70% diameter reduction to evaluate t...
What is the current status of trial NCT02961894?
This trial is currently completed. It is a NA study. The enrollment target is 121 participants. The study started on 2017-06-07. Estimated completion is 2019-09-20.
What interventions are being tested in trial NCT02961894?
The interventions under investigation include: Revolution™ Peripheral Atherectomy System (DEVICE).
Who is sponsoring clinical trial NCT02961894?
This trial is sponsored by Rex Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02961894's enrollment target sits among peer trials
121 762nd of 2000 higher than 1,239 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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