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Drug-Eluting Stent
SELUTION SLR DCB vs. "-limus" DES for Coronary Artery Disease
N/A
Recruiting
Led By Ron Waksman, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the safety and effectiveness of a new type of PTCA DEB for treating narrowed coronary vessels. It will involve 910 people from the US, Canada, Brazil, Japan and Europe.
Who is the study for?
This trial is for adults with small vessel coronary artery disease who need PCI and can tolerate dual antiplatelet therapy. They should not be pregnant, planning surgery within 30 days, or have severe heart failure. Participants must be willing to follow study procedures and use contraception if applicable.
What is being tested?
The SELUTION SLR DCB device is being tested against FDA-approved '-limus' DES in treating de novo lesions in small coronary vessels. This randomized controlled trial aims to enroll up to 910 subjects across multiple countries.
What are the potential side effects?
Potential side effects may include reactions related to the devices used for PCI, bleeding due to antiplatelet therapy, and typical risks associated with catheter-based cardiac procedures such as bruising or infection at the catheter insertion site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 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 1
PK Sub-study Primary Endpoint 2
PK Sub-study Primary Endpoint 3
+2 moreSecondary study objectives
Secondary Endpoint 1
Secondary Endpoint 10
Secondary Endpoint 11
+14 moreOther study objectives
PK Sub-Study Secondary Endpoint 1
PK Sub-Study Secondary Endpoint 2
PK Sub-Study Secondary Endpoint 3
+5 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 014 PTCA DEBExperimental Treatment1 Intervention
SELUTION Sustained Limus Release (SLR) 014 Percutaneous Transluminal Coronary Angioplasty (PTCA) Drug Eluting Balloon (DEB)
The SELUTION SLR 014 PTCA DEB is a minimally invasive, single use and sterile Sirolimus coated PTCA balloon catheter.
The SELUTION SLR 014 PTCA DEB is available with balloon diameters from 2.0 to 3.0 mm and lengths of 15 to 40 mm for the purpose of the De Novo IDE trial
Group II: Control TreatmentActive Control1 Intervention
any FDA approved "limus-based" Drug Eluting Stent, as per standard institutional practice
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Who is running the clinical trial?
NAMSAOTHER
52 Previous Clinical Trials
19,863 Total Patients Enrolled
Cordis CorporationIndustry Sponsor
95 Previous Clinical Trials
124,752 Total Patients Enrolled
50 Trials studying Coronary Artery Disease
78,539 Patients Enrolled for Coronary Artery Disease
M.A. Med Alliance S.A.Lead Sponsor
8 Previous Clinical Trials
5,331 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
3,326 Patients Enrolled for Coronary Artery Disease
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My target lesion is highly likely (>70%) to respond well to specific pre-treatment and DEB.I am scheduled for treatment on a lesion near the beginning of my aorta.I am allergic to Sirolimus or similar medications.I am scheduled for a procedure to open a blocked artery within 30 days after my initial treatment.I have had severe heart failure in the last 6 months.I haven't had a peptic ulcer or GI bleeding in the last 6 months.I am pregnant, breastfeeding, or might become pregnant within a year after the procedure.I tested positive for COVID-19 within 24 hours before my procedure.I am 18 years old or older.I can take aspirin and another blood thinner without issues.I am not pregnant or I am using birth control.My target lesion is in the left main artery or a graft.I have a heart condition that requires a procedure to open blocked arteries.My target lesions meet the trial's specific criteria.I have one treatable lesion in a single blood vessel, with no other lesions in that vessel.I have had successful treatment on up to 2 non-target lesions before this trial.My heart's blood flow is reduced but not completely blocked.My heart condition involves a main artery or its major branch.I have a lesion near a vessel split, but only one vessel needs treatment.I have unstable heart symptoms, including ongoing chest pain.I had a severe heart attack within the last 30 days.I am scheduled for a major surgery within 30 days after the initial procedure.
Research Study Groups:
This trial has the following groups:- Group 1: SELUTION SLR 014 PTCA DEB
- Group 2: Control Treatment
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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