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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
Must not have
Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents, such as contrast agent, which are required for the procedure and which cannot be adequately pre-treated
Symptom onset less than 14 days prior to index procedure (acute limb ischemia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6, 12, 24, 36 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Select...
My leg arteries are open enough for blood flow, as shown by an angiogram.
Select...
My target lesion is in the superficial femoral or popliteal artery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to Sirolimus or certain required medications for the procedure.
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My limb symptoms started less than 14 days ago.
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My cancer needs treatment other than standard options.
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My treatment needs to be delivered through an artery in my arm.
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I have long-term kidney problems.
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I have not had a stroke or heart attack in the last 3 months.
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I need treatment for a lesion that can be accessed through my foot.
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I have had surgery on the main artery in my abdomen or on the arteries in my legs.
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My limb condition is not due to clogged arteries.
Select...
I have a systemic infection or a known immune system problem.
Select...
I have a blood clotting disorder or my platelet count is below 80,000.
Select...
I cannot tolerate dual antiplatelet therapy.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PK Sub-Study Primary Endpoint MRT(last)
PK Sub-Study Primary Endpoint: AUC(last)
PK Sub-Study Primary Endpoint: C(max)
+3 moreSecondary study objectives
Amputation-free survival
Ankle brachial index (ABI)
Any TLR
+26 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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?
Cordis CorporationIndustry Sponsor
95 Previous Clinical Trials
125,412 Total Patients Enrolled
8 Trials studying Peripheral Arterial Disease
1,649 Patients Enrolled for Peripheral Arterial Disease
M.A. Med Alliance S.A.Lead Sponsor
8 Previous Clinical Trials
5,991 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
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.
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