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Stent
Bare Temporary Spur Stent System for Peripheral Arterial Disease (DEEPER REVEAL Trial)
N/A
Recruiting
Research Sponsored by ReFlow Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Target vessel(s) reconstitute(s) at or above the ankle, with the target treated segment ending at least 10 mm above the ankle joint
If the peroneal artery is treated, there must be at least one collateral supplying the foot
Must not have
Symptomatic acute heart failure NYHA class III or greater
Inability to tolerate dual antiplatelet and/or anticoagulation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post procedure
Awards & highlights
No Placebo-Only Group
Summary
This triallooks at the safety and effectiveness of a new medical device for treating narrowed arteries.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, similar procedures may include risks like bleeding at the access site, infection, allergic reactions to materials or medications used (like nitinol), artery damage, or blockage due to clotting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My treatment area is above the ankle and ends more than 10mm from the ankle joint.
Select...
If treated for a leg artery issue, I have at least one working artery to my foot.
Select...
My heart's narrowed artery was successfully widened without complications.
Select...
Blood flows normally to my foot after treatment on specific leg arteries.
Select...
My foot arteries are mostly unblocked.
Select...
My leg artery blockage can be crossed with a wire without going through the vessel wall.
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My previous treatment for narrowed blood vessels was successful, without major issues.
Select...
I am at least 18 years old and not pregnant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe heart failure symptoms.
Select...
I cannot tolerate blood thinning medications.
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I have a major blockage (50% or more) in the arteries leading to my heart or previous treatments for this were unsuccessful.
Select...
My heart's stented artery has narrowed again.
Select...
I have a blood clot in the limb that doctors are focusing on.
Select...
My target lesion is near an aneurysm but the blood flow area is normal.
Select...
I have a damaged stent in my heart or the vessel leading to it.
Select...
I currently have an uncontrolled infection in my body.
Select...
My wound is on my foot, but not on my heel.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the end of the index procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of the index procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Co-Primary Safety Endpoint: Freedom from the occurrence of major adverse limb events (MALE)
Primary Efficacy Endpoint: Technical Success of the Bare Temporary Spur Stent
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Bare Temporary Spur Stent SystemExperimental Treatment1 Intervention
Treatment with the Temporary Bare Spur Stent System (Spur Stent System).
Find a Location
Who is running the clinical trial?
ReFlow Medical, Inc.Lead Sponsor
7 Previous Clinical Trials
910 Total Patients Enrolled
2 Trials studying Peripheral Arterial Disease
126 Patients Enrolled for Peripheral Arterial Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced a specific type of dissection during a procedure called CTO crossing.My treatment area is above the ankle and ends more than 10mm from the ankle joint.I had treatment for inflow lesions within the last 7 days.The healthy part of my vessel near the lesion is longer than 30 mm and doesn't have major narrowing or bulging.I have severe heart failure symptoms.I cannot tolerate blood thinning medications.My non-target lesion treatment was successful without major issues.I have a major blockage (50% or more) in the arteries leading to my heart or previous treatments for this were unsuccessful.My treatment may involve a special technique for reaching blockages in my leg arteries, but the device used must be inserted from above the knee.If treated for a leg artery issue, I have at least one working artery to my foot.My upper leg blockages were treated before considering lower leg treatment.You are allergic to heparin, antiplatelet drugs, or other blood thinners that cannot be replaced, or you are allergic to contrast dye and cannot be treated before a medical procedure.My heart's stented artery has narrowed again.I have a bone infection above the fingers or toes but it may include my digits.I have a blood clot in the limb that doctors are focusing on.The distance from the access point to the treatment area is too far for the stent system's catheter to reach.I have long-term leg pain or minor tissue loss not improved by standard treatments.If I have issues in both limbs, my treatment for the other limb is scheduled around the main procedure by at least 3 days before or 7 days after.My heart's narrowed artery was successfully widened without complications.Blood flows normally to my foot after treatment on specific leg arteries.My target lesion is in the tibial arteries, possibly extending to the distal popliteal segment.My foot arteries are mostly unblocked.I have had or will have treatment for artery blockages in my hip, thigh, or knee area.I have not had any treatments on the target vessel in the last 90 days.My severe artery calcification cannot be treated with balloon angioplasty.My blood vessel's size fits the required range after a successful procedure.I can enroll one limb and one blood vessel in the study, with a possible second treatment for another vessel if needed.My cancer lesion is 210mm or shorter in length.My target lesion is near an aneurysm but the blood flow area is normal.My leg artery blockage can be crossed with a wire without going through the vessel wall.My previous treatment for narrowed blood vessels was successful, without major issues.My treatment plan includes measures to prevent blood clots during atherectomy.My kidney function is very low or I am on dialysis.I have a damaged stent in my heart or the vessel leading to it.I am at least 18 years old and not pregnant.I currently have an uncontrolled infection in my body.My wound is on my foot, but not on my heel.The doctor thinks you will live for at least one more year.I had a specific scan of my blood vessels within the last year, so I don't need another one during my procedure.I am scheduled for or have had a major amputation above the ankle, but minor amputations like toe removals are okay.I have not had a heart attack or stroke in the last 90 days.I have had bypass surgery above my lower leg arteries.I've had treatment for narrowed vessels within a stent, but my stents are not damaged.
Research Study Groups:
This trial has the following groups:- Group 1: Bare Temporary Spur Stent System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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