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Bioresorbable Scaffold
Sirolimus-Eluting Scaffold for Critical Limb Ischemia
N/A
Recruiting
Led By Ehrin Armstrong, MD
Research Sponsored by REVA Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Target lesion(s) must be at least 4 cm above the ankle joint
Target vessel(s) reconstitute(s) at or above the ankle or displays normal terminal branching with inline flow to at least one patent (<50% diameter stenosis by visual assessment) outflow vessel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing a new scaffold to treat infrapopliteal lesions.
Who is the study for?
Adults with symptomatic critical limb ischemia classified as Rutherford category 4 or 5 can join this trial. They must have specific artery blockages in the leg that are treatable with up to four scaffolds and agree to all study procedures. Excluded are those with severe allergies, recent major amputations, other ongoing clinical studies, certain heart conditions, untreated vessel issues, pregnancy, or a life expectancy of less than one year.Check my eligibility
What is being tested?
The MOTIV BTK Trial is testing a new type of scaffold for treating narrow blood vessels below the knee compared to standard balloon angioplasty. The scaffold releases a drug called Sirolimus and dissolves over time aiming to improve blood flow without leaving permanent material behind.See study design
What are the potential side effects?
Possible side effects include allergic reactions to scaffold materials or drugs used during the procedure, bleeding complications due to antiplatelet therapy required after implantation, infection risks from surgery and potential re-narrowing or blockage of treated arteries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My target lesion is higher than 4 cm above my ankle.
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My blood vessels in the leg are open and flow well to my foot.
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My artery leading to the target area is open and mostly clear, confirmed by an imaging test.
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I have severe leg pain at rest due to poor blood flow.
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I have severe narrowing in one or two arteries below my knees.
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My cancer can be treated with up to 4 scaffolds in total.
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I am 18 years old or older.
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The total length of my target lesions does not exceed 120 mm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency
Primary Safety Endpoint: Freedom from Major Adverse Limb Events (MALE) and All-Cause Peri-Operative Death (POD)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MOTIV Sirolimus-Eluting Bioresorbable ScaffoldExperimental Treatment1 Intervention
Participants who receive the MOTIV device will be included in this arm
Group II: Percutaneous Transluminal Angioplasty (PTA)Active Control1 Intervention
Participants who receive PTA treatment will be included in this arm
Find a Location
Who is running the clinical trial?
REVA Medical, Inc.Lead Sponsor
6 Previous Clinical Trials
1,915 Total Patients Enrolled
Ehrin Armstrong, MDPrincipal InvestigatorAdventist Health
1 Previous Clinical Trials
155 Total Patients Enrolled
Andrej Schmidt, PD Dr.Principal InvestigatorUniversity Leipzig
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My target lesion is higher than 4 cm above my ankle.My target lesion can be treated with a stent without blocking major blood vessels.I had a major amputation less than a year ago and cannot walk on my own.My blood vessels in the leg are open and flow well to my foot.My artery leading to the target area is open and mostly clear, confirmed by an imaging test.I had a stroke within the last 3 months.I have severe leg pain at rest due to poor blood flow.I am scheduled for additional primary treatments like radiation or stents in my leg's lower part, but methods like atherectomy are allowed.My cancer is in blood vessels that are very twisted.My artery narrowing has not been successfully treated.I have severe narrowing in one or two arteries below my knees.My kidney function is severely reduced.I have had or need surgery to improve blood flow in a specific blood vessel.I have a significant blockage in a blood vessel that is not being specifically treated.You have a previously treated target lesion with a stent.I am scheduled for a major leg amputation.The target area has severe calcification, as defined by PARC.The blood vessel that needs treatment is between 2.5 mm and 3.75 mm wide, and the available devices can be used to treat it.There is visible evidence of blood clots in the limb being studied.My cancer can be treated with up to 4 scaffolds in total.My condition is classified as severe leg ischemia with tissue loss.I have a blood clotting disorder or cannot take blood thinners.I had a heart attack less than 30 days before my planned procedure.My major artery blockages have been treated successfully.I have had sudden leg pain and weakness or numbness for less than 14 days.My cancer affects areas that move or compress a lot.I am 18 years old or older.You have had a type II heparin-induced thrombocytopenia (HIT) in the past.I have an infection or a condition that weakens my immune system.You have an allergy to the scaffold or its parts.My target vessel was treated less than 3 months ago.My blood vessel blockage is not due to hardening of the arteries.The total length of my target lesions does not exceed 120 mm.
Research Study Groups:
This trial has the following groups:- Group 1: MOTIV Sirolimus-Eluting Bioresorbable Scaffold
- Group 2: Percutaneous Transluminal Angioplasty (PTA)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate count of participants in this clinical research?
"Affirmative. On clinicaltrials.gov, it is evidenced that this medical study - originally posted on June 10th 2022- is actively seeking participants. It requires 292 patients from a single trial site to be enrolled in the experiment."
Answered by AI
Are there any vacancies still open for enrollment in this trial?
"Per the information accessible on clinicaltrials.gov, this research is currently looking for participants. The trial was initially shared in June 2022 and revised as recently as October 19th of that same year."
Answered by AI
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