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

NCT03773081 | Terminated DMC

• 1 other identifier: 4.1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Acute Coronary Syndrome; STE-ACS; NSTE-ACS; Magmaris

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of PCI

Secondary Outcomes (31)

• ST-segment resolution at the electrocardiogram (ECG)

  Within 60 minutes of primary PCI

• Procedural clinical success within hospital stay

  Until hospital discharge, an expected average of 4 days

• Target lesion revascularization

  6 months, 12 months and 2 years

• Device-oriented composite endpoint (DOCE)

  6 months, 12 months and 2 years

• Major adverse cardiovascular events (MACE)

  Until hospital discharge, 6 months, 12 months and 2 years

Study Arms (1)

Magmaris implantation

OTHER

Subjects will undergo a PCI for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice.

Device: Implantation of the Magmaris scaffold

Interventions

Implantation of the Magmaris scaffold DEVICE

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.

Magmaris implantation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Hospitalization for NSTE- ACS in low- and/or risk-class (GRACE-Score ≤ 170) with planned invasive therapy

You may not qualify if:

• 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".

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (4)

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Location

Vivantes Klinikum im Friedrichshain

Berlin, 10249, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Universitätsklinikum Johannes Wesling

Minden, Germany

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Ulf Landmesser, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 12, 2018
• Study Start: August 21, 2018
• Primary Completion: September 15, 2019
• Study Completion: September 15, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

DE (4)