NCT03773081TerminatedNot Applicable
SOLVE-ACS: Prospective Multicenter Evaluation of the Performance of the Bioresorbable Magnesium-Stents Magmaris in Patients With Acute Coronary Syndrome (ACS)
Charite University, Berlin, Germany4 sites in 1 country11 target enrollmentStarted: August 21, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 11
- Locations
- 4
- Primary Endpoint
- Procedural angiographical success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Implantation of the Magmaris scaffold (Device)
Outcomes
Primary Outcomes
Procedural angiographical success
Time Frame: At the end of PCI
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 Outcomes
- ST-segment resolution at the electrocardiogram (ECG)(Within 60 minutes of primary PCI)
- Neointimal hyperplasia area/volume(24 months)
- Major adverse cardiovascular events (MACE)(Until hospital discharge, 6 months, 12 months and 2 years)
- Cardiac death at all time points(Until hospital discharge, 6 months, 12 months and 2 years)
- Any Bleeding(Until hospital discharge, 6 months, 12 months and 2 years)
- Vascular cerebral events(Until hospital discharge, 6 months, 12 months and 2 years)
- Target lesion revascularization(6 months, 12 months and 2 years)
- Device-oriented composite endpoint (DOCE)(6 months, 12 months and 2 years)
- All-cause death at all time points(Until hospital discharge, 6 months, 12 months and 2 years)
- Percent diameter stenosis(24 months)
- Presence of both malapposed and uncovered struts(24 months)
- Procedural clinical success within hospital stay(Until hospital discharge, an expected average of 4 days)
- Magmaris Thrombosis(Until hospital discharge, 6 months, 12 months and 2 years)
- ACS-causing "culprit lesion" (OCT)(24 months)
- Mean/minimal flow-area/volume(24 months)
- Minimal Lumen Diameter (MLD)(24 months)
- Max/Mean/minimal Mg-Stent diameter/area after implantation and lumen late loss (OCT)(24 months)
- Mean/minimal lumen diameter/area/volume(24 months)
- Modified vascular healing score(24 months)
- Presence of malapposed struts alone(24 months)
- Thickness of neointimal tissue developed over lipid rich plaque(24 months)
- Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG determination (MCG-substudy)(24 months)
- Stable angina(6 months, 12 months and 2 years)
- Evidence for myocardial ischemia(12 months)
- TIMI-flow(24 month)
- Intraluminal defect area/volume(24 months)
- Presence of uncovered struts alone(24 months)
- Incomplete strut apposition (ISA) area/volume(24 months)
- Percentage of covered struts(24 months)
- Mean/maximal thickness of the struts coverage(24 months)
- Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG Determination (MCG-substudy)(24 months)
Investigators
David Manuel Leistner
Coordinating Investigator
Charite University, Berlin, Germany
Study Sites (4)
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