SOLVE-ACS: Bioresorbable Magnesium-Stents Magmaris in ACS Lesions

Charite University, Berlin, Germany11 enrolled

Overview

The aim of the registry is to investigate the clinical performance of the Magmaris Magnesium Stent in STE-ACS and NSTE-ACS patients.

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 Non-ST-segment elevation (NSTE-) acute coronary syndrome (ACS). Patients scheduled for this registry, must have one angiographic clear detectable ACS-causing culprit lesion with a reference diameter and a lesion length, which closely match the nominal Magmaris reference diameter and length. Primary endpoint will be the procedural angiographical success at the end of PCI, defined as successful Magmaris implantation at the "culprit lesion site" with less than 30% final stenosis (by visual estimation) and distal TIMI 3 flow. Secondary endpoints will include clinical and angiographic parameters as well as parameters gained through OCT-imaging.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Coronary Syndrome STEMI - ST Elevation Myocardial Infarction NSTEMI - Non-ST Segment Elevation MI

Interventions

Implantation of the Magmaris scaffoldDEVICE

Subjects will undergo a PCI for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice. Maximum of one single ACS-causing de novo lesions in one separate major epicardial vessels is allowed.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Locations (4)

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Vivantes Klinikum im Friedrichshain

Berlin, Germany

Charité Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Johannes Wesling

Minden, Germany

Outcomes

Primary Outcomes

Procedural angiographical success

Procedural angiographical success at the end of PCI, defined as successful Magmaris implantation at the "culprit lesion site" with less than 30% final stenosis (by visual estimation) and distal TIMI 3 flow.

Time frame: At the end of PCI

Secondary Outcomes

ST-segment resolution at the electrocardiogram (ECG)

ST-segment resolution at ECG.

Time frame: Within 60 minutes of primary PCI

Procedural clinical success within hospital stay

No in-hospital clinically-driven target lesion revascularization.

Time frame: Until hospital discharge, an expected average of 4 days

Target lesion revascularization

Clinical driven target-lesion revascularization with the use of either PCI or CABG at 6 months, 12 months and at 2 years follow-up respectively.

Time frame: 6 months, 12 months and 2 years

Device-oriented composite endpoint (DOCE)

Device-oriented composite (DOCE) endpoint of cardiac death, target vessel-related reinfarction and ischemia-driven target-lesion revascularization at 6 months, 12 months and at 2 years follow-up respectively.

Time frame: 6 months, 12 months and 2 years

Major adverse cardiovascular events (MACE)

Cardiac death, any TV-MI, target vessel revascularization (TVR) in-hospital or during follow-up (6 months, 12 months, 2 years).