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Drug Eluting Balloon
Drug-Coated Balloon Angioplasty for Peripheral Arterial Disease
N/A
Recruiting
Research Sponsored by M.A. Med Alliance S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to walk without the assistance of a walker
Documented ischemia with Rutherford classification category 2, 3 or 4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6, 12, 24, 36 months
Awards & highlights
Study Summary
This trialtests a new device to treat peripheral arterial disease in the leg arteries.
Who is the study for?
Adults with peripheral arterial disease in the superficial femoral or proximal popliteal artery, able to walk unassisted and expected to live more than a year. Women of childbearing age must test negative for pregnancy and use contraception post-treatment. Participants cannot have had recent surgeries or be scheduled for upcoming ones, nor can they have conditions like severe kidney issues, blood disorders, allergies to Sirolimus, or be breastfeeding.Check my eligibility
What is being tested?
The trial is testing SELUTION SLR™ 018 DEB's safety and effectiveness against plain balloon angioplasty for treating narrowed arteries due to PAD. It focuses on patients' legs where the blood flow has been reduced because of blockages in specific arteries.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include local reactions at the catheter insertion site such as bleeding or bruising, infection risk from invasive procedures, allergic reactions to drug components like Sirolimus or contrast agents used during angiography.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk on my own without needing a walker.
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I have moderate to severe leg pain from poor blood flow.
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My target lesion is in the superficial femoral or popliteal artery.
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My leg arteries are open enough for blood flow, as shown by an angiogram.
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My target lesion is in the superficial femoral or popliteal artery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 3, 6, 12, 24, 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6, 12, 24, 36 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
Primary Safety Endpoint
Secondary outcome measures
Amputation-free survival
Ankle brachial index (ABI)
Any TLR
+19 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SELUTION SLR™ 018 DEBExperimental Treatment1 Intervention
Treatment with Selution SLR drug eluting balloon to apply long term (>90 days) local treatment with sirolimus
Group II: Plain (Uncoated) Balloon Angioplasty (PTA)Active Control1 Intervention
Opening artery only by dilatation with an temporary inserted and inflated balloon.
Find a Location
Who is running the clinical trial?
M.A. Med Alliance S.A.Lead Sponsor
8 Previous Clinical Trials
5,941 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
1,203 Patients Enrolled for Peripheral Arterial Disease
MedAlliance, LLCLead Sponsor
1 Previous Clinical Trials
376 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
376 Patients Enrolled for Peripheral Arterial Disease
NAMSAOTHER
45 Previous Clinical Trials
16,623 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
682 Patients Enrolled for Peripheral Arterial Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman able to have children, have a recent negative pregnancy test, and will use birth control for a year after treatment.I can receive treatment for outflow disease but not with drug-eluting devices.The blood vessel being treated is between 4mm and 7mm in diameter.I am 18 years old or older.The area of concern in the blood vessels is either a new problem, a previously treated area that has narrowed again, or a combination of both.I am allergic to Sirolimus or certain required medications for the procedure.You have a stent in the artery that will be treated in this study.My limb symptoms started less than 14 days ago.My cancer needs treatment other than standard options.Your blood vessels have a blockage of at least 30% even after a procedure to widen them.My treatment needs to be delivered through an artery in my arm.I have long-term kidney problems.The doctor thinks you have at least one more year to live.I can walk on my own without needing a walker.I have not had a stroke or heart attack in the last 3 months.I need treatment for a lesion that can be accessed through my foot.I have moderate to severe leg pain from poor blood flow.I need treatment for a condition in my other leg around the time of my main procedure.The treatment did not work to shrink the main tumor.I have had surgery on the main artery in my abdomen or on the arteries in my legs.Your major arteries are free from blockages, as confirmed by a special x-ray test called angiography.My limb condition is not due to clogged arteries.The target area for the study is in the upper leg arteries.My target lesion is in the superficial femoral or popliteal artery.The blood vessel being treated is between 4 and 7 millimeters in diameter.My leg arteries are open enough for blood flow, as shown by an angiogram.I have a systemic infection or a known immune system problem.My target lesion is in the superficial femoral or popliteal artery.I haven't had or planned any surgery on the limb in question except for diagnostic angiography.I have a blood clotting disorder or my platelet count is below 80,000.I cannot tolerate dual antiplatelet therapy.
Research Study Groups:
This trial has the following groups:- Group 1: SELUTION SLR™ 018 DEB
- Group 2: Plain (Uncoated) Balloon 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.
Are there any more opportunities for volunteers to join this clinical trial?
"Clinicialtrials.gov has reported that this medical experiment is in the process of recruiting patients, with an initial posting date on December 1st 2022 and a recent update occurring on December 19th 2022."
Answered by AI
To what limit is the capacity of participants in this trial?
"Affirmative. Clinicaltrials.gov alludes to the fact that this research initiative is actively recruiting participants, which commenced on December 1st 2022 and has been recently modified on December 19th 2022. This clinical study requires 300 volunteers across a single medical institution."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Vascular Institute of the Midwest
What portion of applicants met pre-screening criteria?
Met criteria
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