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NCT05358353 · ClinicalTrials.gov registry record · NA
A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)
A NA study of Peripheral Arterial Disease and Critical Limb Ischemia, sponsored by ReFlow Medical.
- Completed
- Registry status
- NA
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT05358353: Completed NA study of Peripheral Arterial Disease and Critical Limb Ischemia, sponsored by ReFlow Medical.
NCT05358353 is a NA study of Peripheral Arterial Disease and Critical Limb Ischemia that has completed, run by ReFlow Medical. The registered enrollment target is 130 participants, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05358353, a NA study of Peripheral Arterial Disease and Critical Limb Ischemia, has completed, sponsored by ReFlow Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).
Primary Outcome
Technical Success is defined as \<30% residual stenosis in subjects treated with the Bare Temporary Spur Stent System
Conditions Studied
Interventions
- DEVICE Bare Temporary Spur Stent System
Study Locations (20)
Florida
- Palm Beach Heart and Vascular - Boynton Beach
- Bradenton Cardiology - Bradenton
- Delray Medical Center - Delray Beach
- First Coast Cardiovascular Institute - Fleming Island
- Baptist Hospital of Miami - Miami
- Surgical Specialists of Ocala - Ocala
- Ansaarie Cardiac & Endovascular Center of Excellence - Palatka
- Coastal Vascular and Interventional Center - Pensacola
- Guardian Research - Winter Park
Arkansas
- St. Bernards Heart and Vascular - Jonesboro
- Arkansas Heart Hospital - Little Rock
California
- University of California, Irvine Health - Orange
- Vascular & Interventional Specialist of Orange County - Orange
Connecticut
- Vascular Care Connecticut (site) / Vascular Breakthroughs (research support) - Darien
- Southern CT Vascular Center - Shelton
Illinois
- Rush University - Chicago
- Midwest Cardiovascular Institute - Naperville
Colorado
- Rocky Mountain Regional VA Medical Center - Aurora
Indiana
- Community Healthcare Systems - Munster
Iowa
- UnityPoint Health Trinity Bettendorf Hospital - Bettendorf
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2022-10-18 |
| Est. Completion | 2025-05-23 |
| Phase | NA |
What the finished NCT05358353 record still lists
NCT05358353 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 1 intervention - of which Bare Temporary Spur Stent System is the first listed.
NCT05358353 names 20 study sites across 8 states, led by Florida, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT05358353 about?
NCT05358353 is a clinical study titled "A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)". This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).
What is the current status of trial NCT05358353?
This trial is currently completed. It is a NA study. The enrollment target is 130 participants. The study started on 2022-10-18. Estimated completion is 2025-05-23.
What conditions does trial NCT05358353 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Critical Limb Ischemia.
What interventions are being tested in trial NCT05358353?
The interventions under investigation include: Bare Temporary Spur Stent System (DEVICE).
Who is sponsoring clinical trial NCT05358353?
This trial is sponsored by ReFlow Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05358353 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05358353's enrollment target sits among peer trials
130 33rd of 79 higher than 47 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial 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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