Bare Temporary Spur Stent System for Peripheral Arterial Disease

(DEEPER REVEAL Trial)

No longer recruiting at 52 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment method for Peripheral Arterial Disease (PAD), which causes poor blood flow in the legs. The method uses a temporary device called the Bare Temporary Spur Stent System to open blocked arteries in the legs. Individuals with chronic symptoms, such as leg pain at rest or minor tissue loss due to poor circulation unresponsive to regular treatments, might be suitable candidates. The trial will determine if this new approach can improve blood flow and reduce symptoms in affected individuals. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could lead to innovative treatments for PAD.

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 prior data suggests that the Bare Temporary Spur Stent System is safe for treating Peripheral Arterial Disease?

Research has shown that the Bare Temporary Spur Stent System is safe for treating peripheral artery disease. One study significantly reduced artery narrowing, achieving an 85.7% success rate. Another study found it safe and effective for treating artery disease below the knee over a year.

Early results from other research also suggest the device is safe, but more studies are needed to confirm this. Overall, the data so far appears promising for those considering this treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Bare Temporary Spur Stent System is unique because it offers a novel approach to treating Peripheral Arterial Disease (PAD). Unlike traditional options like drug-coated balloons or permanent stents, this system temporarily props open the artery to improve blood flow without leaving a permanent implant. This temporary design could reduce risks associated with long-term inflammation or stent-related complications. Researchers are excited about its potential to improve patient outcomes while minimizing the need for additional interventions.

What evidence suggests that the Bare Temporary Spur Stent System is effective for Peripheral Arterial Disease?

Research has shown that the Bare Temporary Spur Stent System, which participants in this trial will receive, holds promise for treating peripheral arterial disease. One study found that the stent maintained blood flow in 74.4% of treated areas after one year. It was technically successful in 85.7% of cases, reducing artery narrowing to less than 30%. Early results also suggest that this stent might help keep arteries open and improve medication delivery. While these findings are encouraging, they remain preliminary, and further research is needed to confirm long-term benefits. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. jacc.org jacc.org/doi/10.1016/j.jcin.2024.01.153

300.04 One-Year Results of the DEEPER OUS Trial 12 month outcomes Target lesion primary patency was 74.4% (61/82) overall; 75% (6/8) at the single center. CD-TLR was 89.5% (85/95) overall; 83%; (10/12) at the ...

2. reflowmedical.com reflowmedical.com/spur/

Spur US Core lab adjudicated technical success of <30% stenosis was 85.7% (120/140 lesions); 3. MALE defined as: above-the-ankle amputation of the index limb, OR major ...

3. jvascsurg.org jvascsurg.org/article/S0741-5214(24)00162-9/fulltext

One Year Results of the DEEPER LIMUS Trial Evidence suggests that the Bare Temporary Spur Stent System may be a safe and effective treatment for infrapopliteal arterial disease when used in conjunction ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05358353

Study Details | NCT05358353 | A Prospective Single-Arm ... 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).

5. tctmd.com tctmd.com/news/early-data-temporary-spur-btk-pad-show-efficacy-limited-recoil

Early Data on Temporary Spur in BTK PAD Show Efficacy ... The spiky stent may limit vessel recoil and improve drug delivery, but it's still too early for strong conclusions, says Sahil Parikh.

6. jvascsurg.org jvascsurg.org/article/S0741-5214(23)00174-X/fulltext

DEEPER LIMUS Study Update: The Bare Temporary Spur ... Preliminary results suggest that the Temporary Spur Stent System is safe for treatment of infrapopliteal artery disease. Further research must be conducted ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05358353

Study Details | NCT05358353 | A Prospective Single-Arm ... 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).

8. reflowmedical.com reflowmedical.com/reflow-medical-announces-one-year-results-of-deeper-ous-clinical-trial/

Reflow Medical Announces One-Year Results of DEEPER ... “We observed a statistically significant reduction in Rutherford class scores and wound healing at six months, with sustained improvement in ...