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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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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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.
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I have a systemic infection or a known immune system problem.
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I have a blood clotting disorder or my platelet count is below 80,000.
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I cannot tolerate dual antiplatelet therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6, 12, 24, 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, 12, 24, 36 months for reporting.

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 more
Secondary study objectives
Amputation-free survival
Ankle brachial index (ABI)
Any TLR
+26 more

Awards & 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

SELUTION SLR™ 018 DEB (Drug Eluting Balloon) Clinical Trial Eligibility Overview. Trial Name: NCT05132361 — N/A
Peripheral Arterial Disease Research Study Groups: SELUTION SLR™ 018 DEB, Plain (Uncoated) Balloon Angioplasty (PTA)
Peripheral Arterial Disease Clinical Trial 2023: SELUTION SLR™ 018 DEB Highlights & Side Effects. Trial Name: NCT05132361 — N/A
SELUTION SLR™ 018 DEB (Drug Eluting Balloon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05132361 — N/A
~0 spots leftby Dec 2024
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