Bare Temporary Spur Stent System for Peripheral Arterial Disease

(DEEPER REVEAL Trial)

Recruiting at 50 trial locations

Overseen By Ian Cawich

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ReFlow Medical, Inc.

Must not be taking: Antiplatelets, Anticoagulants, Heparin

Disqualifiers: Pregnancy, Infection, Heart failure, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: During the index procedure

130 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be able to tolerate dual antiplatelet and/or anticoagulation therapy, and you should not have allergies to these medications that cannot be managed.

What data supports the effectiveness of the Bare Temporary Spur Stent System treatment for Peripheral Arterial Disease?

Research shows that bare metal stents, which are similar to the Bare Temporary Spur Stent System, have improved outcomes for patients with peripheral artery disease, particularly in the iliac arteries. These stents help keep arteries open and maintain blood flow, which is crucial for treating this condition. ^{1 2 3 4 5}

Is the Bare Temporary Spur Stent System generally safe for humans?

The safety of bare metal stents, which are similar to the Bare Temporary Spur Stent System, has been studied in various conditions. While they are generally considered safe, there can be risks like restenosis (re-narrowing of the artery) and complications such as thrombus (blood clot) formation, which can lead to serious heart issues. ^{3 6 7 8 9}

How is the Bare Temporary Spur Stent System treatment different from other treatments for peripheral arterial disease?

The Bare Temporary Spur Stent System is unique because it is designed to be a temporary stent, which may reduce the risk of long-term complications associated with permanent stents. This approach could potentially offer a novel solution for maintaining blood flow in peripheral arteries without the need for a permanent implant. ^{1 4 10 11 12}

Eligibility Criteria

Adults over 18 with critical limb ischemia or peripheral vascular disease affecting the legs, specifically below the knee. Participants must have symptoms not improved by standard treatments and be able to consent and follow study procedures. They should expect to live at least another year and can't be on dialysis, pregnant, or planning pregnancy during the trial.

Inclusion Criteria

My treatment area is above the ankle and ends more than 10mm from the ankle joint.

The healthy part of my vessel near the lesion is longer than 30 mm and doesn't have major narrowing or bulging.

My non-target lesion treatment was successful without major issues.

Exclusion Criteria

You have experienced a specific type of dissection during a procedure called CTO crossing.

I had treatment for inflow lesions within the last 7 days.

I have severe heart failure symptoms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Temporary Bare Spur Stent System

During the index procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at 30 days post procedure

Treatment Details

Interventions

• Bare Temporary Spur Stent System

Trial Overview The safety and effectiveness of a new Bare Temporary Spur Stent System for treating blood vessel blockages in the lower leg are being tested. This single-arm study involves placing this stent system into affected arteries to improve blood flow.

Participant Groups

Group I: Bare Temporary Spur Stent System Experimental Treatment 1 Intervention

Treatment with the Temporary Bare Spur Stent System (Spur Stent System).

Who Is Running the Clinical Trial?

ReFlow Medical, Inc.

Lead Sponsor

Trials

8

Recruited

1,000+

References

1. Italy pubmed.ncbi.nlm.nih.gov

Bare metal stenting of the iliac arteries. [2016]

2. Ireland pubmed.ncbi.nlm.nih.gov

Outcome after percutaneous coronary intervention with contemporary stents in patients with concomitant peripheral arterial disease: A patient-level pooled analysis of four randomized trials. [2022]

3. England pubmed.ncbi.nlm.nih.gov

One-year clinical outcome after primary stenting for Trans-Atlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions (the STELLA "STEnting Long de L'Artère fémorale superficielle" cohort). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Outcomes of polytetrafluoroethylene-covered stent versus bare-metal stent in the primary treatment of severe iliac artery obstructive lesions. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Indications and results of arterial stents for occlusive disease. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A history of prior bare metal stent restenosis is associated with major adverse cardiac events in subsequent bare metal stenting of de novo coronary lesions. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Italian Multicenter Registry of Bare Metal Stent Use in Modern Percutaneous Coronary Intervention Era (AMARCORD): A multicenter observational study. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of small thrombus formation in restenotic bare-metal stent lesions associated with acute coronary syndrome: identification by optical coherence tomography. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Five-year follow-up of the Sirolimus-Eluting Stents vs Vascular Brachytherapy for Bare Metal In-Stent Restenosis (SISR) trial. [2016]

10. Canada pubmed.ncbi.nlm.nih.gov

Paclitaxel Drug-Eluting Stents in Peripheral Arterial Disease: A Health Technology Assessment. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Day-Case Treatment of Peripheral Arterial Disease: Results from a Multi-Center European Study. [2022]

12. Italy pubmed.ncbi.nlm.nih.gov

Non-randomized, prospective, multi-centre evaluation of the ABSOLUTE .035 peripheral self-expanding stent system for occluded or stenotic superficial femoral or proximal popliteal arteries (ASSESS Trial): acute and 30-day results. [2019]