Status:
TERMINATED
BIOSOLVE-IV Magmaris Swiss Satellite Registry
Lead Sponsor:
University Hospital, Geneva
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
BIOSOLVE-IV Magmaris Swiss Satellite Registry is a prospective, single-arm, multicenter, nationwide open label registry. It is planned to enroll 200 subjects in up to 12 participating sites in Switzer...
Eligibility Criteria
Inclusion
- Subject is ≥18 years of age
- Subject must be willing to sign a Patient Informed Consent
- Symptomatic coronary artery disease
- Subject with a maximum of two single de novo lesions in two different major epicardial vessels
- Target lesion length ≤ 21 mm by QCA or by visual estimation
- Target lesion stenosis \>50% and \<100% by visual estimation, and TIMI flow ≥1.
- Subject is eligible for Dual Anti Platelet Therapy (DAPT)
- Reference vessel diameter between 2.7-3.7 mm by visual estimation, depending on the scaffold size used
Exclusion
- Pregnant and/or breastfeeding females or females who intend to become pregnant during the time of the registry
- Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, heparin or any other anticoagulant /antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs; or the scaffold materials including Magnesium, Yttrium, Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum that cannot be adequately pre-medicated
- Subjects on dialysis
- Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment
- Documented left ventricular ejection fraction (LVEF) ≤30% as documented within maximum 6 months prior to the procedure
- Heavily calcified or extremely tortuous lesions
- Bifurcation lesion requiring side branch intervention, if side branches \>2 mm in diameter are involved
- Restenotic target lesion
- Thrombus in target vessel
- Target lesion is located in or supplied by a diseased (defined as vessel irregularity per angiogram and \>20% stenosed lesion by visual estimation) arterial or venous bypass graft
- Left main coronary artery disease
- Ostial target lesion (within 5.0 mm of vessel origin)
- Target vessel (including side branches) has second lesion which requires treatment according to the investigator's discretion
- Unsuccessful pre-dilatation, defined as residual stenosis rate \>20% by visual estimation and/or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections)
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
- Currently participating in another study and primary endpoint is not reached yet
- Planned interventional treatment of any non-target vessel within 30 days post procedure
- Planned intervention of the target vessel within 6-month after the index procedure
Key Trial Info
Start Date :
March 26 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04025788
Start Date
March 26 2019
End Date
January 1 2022
Last Update
August 2 2022
Active Locations (6)
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1
Unité de Cardiologie interventionnelle, Service de cardiologie, Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1205
2
Kantonsspital Baselland, Kardiologie
Liestal, Switzerland, 4410
3
Ensemble Hospitalier de la Côte, Hôpital de Morges, Cardiologie
Morges, Switzerland, 1110
4
Interventionnelle Kardiologie, Kantonspital St.Gallen, Kardiologie
Sankt Gallen, Switzerland, 9000