Clinical trial NCT03773081: SOLVE-ACS: Bioresorbable Magnesium-Stents Magmaris in ACS Lesions
Official title: SOLVE-ACS: Prospective Multicenter Evaluation of the Performance of the Bioresorbable Magnesium-Stents Magmaris in Patients With Acute Coronary Syndrome (ACS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Coronary Syndrome
STEMI - ST Elevation Myocardial Infarction
NSTEMI - Non-ST Segment Elevation MI
Keywords: Acute Coronary Syndrome
STE-ACS
NSTE-ACS
Magmaris
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Procedural angiographical success
timeFrame: At the end of PCI
Secondary outcomes:
measure: ST-segment resolution at the electrocardiogram (ECG)
timeFrame: Within 60 minutes of primary PCI
measure: Procedural clinical success within hospital stay
timeFrame: Until hospital discharge, an expected average of 4 days
measure: Target lesion revascularization
timeFrame: 6 months, 12 months and 2 years
measure: Device-oriented composite endpoint (DOCE)
timeFrame: 6 months, 12 months and 2 years
measure: Major adverse cardiovascular events (MACE)
timeFrame: Until hospital discharge, 6 months, 12 months and 2 years
measure: All-cause death at all time points
timeFrame: Until hospital discharge, 6 months, 12 months and 2 years
measure: Cardiac death at all time points
timeFrame: Until hospital discharge, 6 months, 12 months and 2 years
measure: Magmaris Thrombosis
timeFrame: Until hospital discharge, 6 months, 12 months and 2 years
measure: Any Bleeding
timeFrame: Until hospital discharge, 6 months, 12 months and 2 years
measure: Vascular cerebral events
timeFrame: Until hospital discharge, 6 months, 12 months and 2 years
measure: Stable angina
timeFrame: 6 months, 12 months and 2 years
measure: Evidence for myocardial ischemia
timeFrame: 12 months
measure: Percent diameter stenosis
timeFrame: 24 months
measure: Minimal Lumen Diameter (MLD)
timeFrame: 24 months
measure: TIMI-flow
timeFrame: 24 month
measure: ACS-causing "culprit lesion" (OCT)
timeFrame: 24 months
measure: Max/Mean/minimal Mg-Stent diameter/area after implantation and lumen late loss (OCT)
timeFrame: 24 months
measure: Mean/minimal lumen diameter/area/volume
timeFrame: 24 months
measure: Mean/minimal flow-area/volume
timeFrame: 24 months
measure: Intraluminal defect area/volume
timeFrame: 24 months
measure: Modified vascular healing score
timeFrame: 24 months
measure: Presence of both malapposed and uncovered struts
timeFrame: 24 months
measure: Presence of uncovered struts alone
timeFrame: 24 months
measure: Presence of malapposed struts alone
timeFrame: 24 months
measure: Incomplete strut apposition (ISA) area/volume
timeFrame: 24 months
measure: Percentage of covered struts
timeFrame: 24 months
measure: Mean/maximal thickness of the struts coverage
timeFrame: 24 months
measure: Neointimal hyperplasia area/volume
timeFrame: 24 months
measure: Thickness of neointimal tissue developed over lipid rich plaque
timeFrame: 24 months
measure: Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG determination (MCG-substudy)
timeFrame: 24 months
measure: Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG Determination (MCG-substudy)
timeFrame: 24 months
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Minden
country: Germany
facility: Universitätsklinikum Johannes Wesling
Study officials:
affiliation: Charite University, Berlin, Germany
name: Ulf Landmesser, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: