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

Charité University Medicine Berlin

Status

Terminated

Conditions

NSTEMI - Non-ST Segment Elevation MI

Acute Coronary Syndrome

STEMI - ST Elevation Myocardial Infarction

Treatments

Device: Implantation of the Magmaris scaffold

Study type

Interventional

Funder types

Other

Identifiers

NCT03773081

4.1

Details and patient eligibility

About

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

Full 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 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.

Enrollment

11 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.