Acute Coronary Syndrome Clinical Trial
Official title:
SOLVE-ACS: Prospective Multicenter Evaluation of the Performance of the Bioresorbable Magnesium-Stents Magmaris in Patients With Acute Coronary Syndrome (ACS)
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.
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