Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT05358353 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ReFlow Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05358353 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05358353?
The interventions under investigation include: Bare Temporary Spur Stent System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05358353?
This trial is sponsored by ReFlow Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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