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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05358353
The ClinicalTrials.gov registry entry for NCT05358353 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (97% lower). The listed sponsor is ReFlow Medical, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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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