Bare Temporary Spur Stent System for Peripheral Arterial Disease

(DEEPER REVEAL Trial)

Recruiting at50 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: ReFlow Medical, Inc.

No Placebo Group

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).

Research Team

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.

Treatment Details

Interventions

• Bare Temporary Spur Stent System (Stent)

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+