Status:
TERMINATED
SOLVE-ACS: Bioresorbable Magnesium-Stents Magmaris in ACS Lesions
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Acute Coronary Syndrome
STEMI - ST Elevation Myocardial Infarction
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The aim of the registry is to investigate the clinical performance of the Magmaris Magnesium Stent in STE-ACS and NSTE-ACS patients.
Detailed Description
The Magmaris Magnesium-Stent is indicated for improving luminal diameter and stabilize culprit lesions in patients with coronary artery disease (CAD) including ST-segment elevation (STE-) as well as N...
Eligibility Criteria
Inclusion
- Male or female patients of 18 - 70 years of age
- STE- or NSTE-ACS with planned invasive therapy strategy
- At least coronary one-vessel disease with one angiographically detectable "culprit lesion"
- Target lesion length ≤ 21 mm and its diameter is ≥ 2.7mm and ≤ 3.7 mm by QCA or by visual estimation.
- Subject is eligible for Dual Anti Platelet Therapy (DAPT) for 12 months after ACS
- Additional inclusion criteria MCG-substudy:
- Hospitalization for NSTE- ACS in low- and/or risk-class (GRACE-Score ≤ 170) with planned invasive therapy
Exclusion
- Currently participating within a FIM or RCT and primary endpoint is not reached yet.
- Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, ticlopidine, prasugrel, heparin or any other anticoagulant /antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs or the Magmaris materials including Magnesium, Yttrium, Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum that cannot be adequately pre-medicated.
- Renal insufficiency with serum-creatinine ≥ 2.5 mg/dl or subjects on dialysis.
- Known systolic heart failure with left-ventricular ejection fraction (LV-EF≤ 30 %).
- Active sepsis.
- Presence of cardiogenic shock or heart failure requiring intubation, inotropes, intravenous diuretics or mechanical circulation support.
- Refractory ventricular arrhythmia requiring pharmacologic or defibrillator therapy.
- Patients under immunosuppressive therapy.
- Unprotected significant left main- stenosis.
- ACS with culprit lesion in a bypass graft or ACS caused by stent/BVS-thrombosis or stent/BVS-restenosis.
- ACS caused by left main coronary artery disease or an ostial target lesion (within 5.0 mm of vessel origin).
- Culprit lesion involves a side branch ≥2.0 mm in diameter (bifurcation lesion).
- Culprit lesion located within a true vessel bifurcation (including side branch \> 2mm) which requires bifurcation-treatment according to the investigator's discretion.
- Extent and severity of CAD is such that investigator believes it is likely that bypass surgery will be required within 1 year of enrollment.
- Severe calcification or extreme tortuosity of vessel with "culprit lesion".
- Culprit lesion with very distal location.
- Culprit vessels with "low or no-reflow phenomenon" (TIMI 0,I,II) after mechanical recanalization or pre-dilatation using a non-compliant balloon with 1:1 balloon-to-artery ratio.
- Culprit lesions with a length ≥ 21 mm or within vessels with reference diameter≤ 2.7mm or ≥ 3.7 mm by QCA or by visual estimation.
- Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of Magmaris and angiographic complications (e.g. distal embolization, side branch closure, extensive dissections), by visual estimation.
- Additional exclusion criteria MCG-substudy:
- Non-MCG-safe metal implants
- Inability or unwillingness to lie flat for 5 minutes and follow breathing commands
Key Trial Info
Start Date :
August 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03773081
Start Date
August 21 2018
End Date
September 15 2019
Last Update
September 17 2019
Active Locations (4)
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1
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
2
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
3
Charité Universitätsmedizin Berlin
Berlin, Germany, 12203
4
Universitätsklinikum Johannes Wesling
Minden, Germany