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

Acute Coronary Syndrome Clinical Trial

— SOLVE-ACS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03773081
• Other study ID #: 4.1
• Status: Terminated
• Phase: N/A
• Start date: August 21, 2018
• Est. completion date: September 15, 2019

Study information

• Verified date: September 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: September 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Implantation of the Magmaris scaffold
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.

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Vivantes Klinikum im Friedrichshain	Berlin
Germany	Universitätsklinikum Johannes Wesling	Minden

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ST-segment resolution at the electrocardiogram (ECG)	ST-segment resolution at ECG.	Within 60 minutes of primary PCI
Secondary	Procedural clinical success within hospital stay	No in-hospital clinically-driven target lesion revascularization.	Until hospital discharge, an expected average of 4 days
Secondary	Target lesion revascularization	Clinical driven target-lesion revascularization with the use of either PCI or CABG at 6 months, 12 months and at 2 years follow-up respectively.	6 months, 12 months and 2 years
Secondary	Device-oriented composite endpoint (DOCE)	Device-oriented composite (DOCE) endpoint of cardiac death, target vessel-related reinfarction and ischemia-driven target-lesion revascularization at 6 months, 12 months and at 2 years follow-up respectively.	6 months, 12 months and 2 years
Secondary	Major adverse cardiovascular events (MACE)	Cardiac death, any TV-MI, target vessel revascularization (TVR) in-hospital or during follow-up (6 months, 12 months, 2 years).	Until hospital discharge, 6 months, 12 months and 2 years
Secondary	All-cause death at all time points	Clinical Endpoint (in-hospital and at follow-up (6 months, 12 months, 2 years).	Until hospital discharge, 6 months, 12 months and 2 years
Secondary	Cardiac death at all time points	Clinical Endpoint (in-hospital and at follow-up (6 months, 12 months, 2 years).	Until hospital discharge, 6 months, 12 months and 2 years
Secondary	Magmaris Thrombosis	Any definite/probable per ARC defintion Magmaris thrombosis (in-hospital and during follow-up (6 months, 12 months, 2 years).	Until hospital discharge, 6 months, 12 months and 2 years
Secondary	Any Bleeding	Bleedings defined according to the Bleeding Academic Research Consortium (BARC) in-hospital and at follow-up (in-hospital and at follow-up (6 months, 12 months, 2 years).	Until hospital discharge, 6 months, 12 months and 2 years
Secondary	Vascular cerebral events	Vascular events documented by neurological permanent disabilities or by diagnostic imaging (MRI or CT) in-hospital and during follow-up (6 months, 12 months, 2 years).	Until hospital discharge, 6 months, 12 months and 2 years
Secondary	Stable angina	Angina as assessed by Seattle angina score (SAS) at follow-up (6 months, 12 months, 2 years).	6 months, 12 months and 2 years
Secondary	Evidence for myocardial ischemia	Clinical or ECG-signs for myocardial ischemia during exercise ECG at 12-month follow-up.	12 months
Secondary	Percent diameter stenosis	Percent diameter stenosis (%DS) at in in-segment (target lesion), in-device, proximal and distal (initial and in case of clinical-indicated re-angiography) (assessed by outcome-blinded Corelab analyses, Charite).	24 months
Secondary	Minimal Lumen Diameter (MLD)	Minimal Lumen Diameter in-segment (target lesion), in-device, proximal and distal (initial and in case of clinical-indicated re-angiography) (assessed by outcome-blinded Corelab analyses, Charite).	24 months
Secondary	TIMI-flow	TIMI-flow before (after mechanical recanalization) and after Magmaris Implantation (assessed by outcome-blinded Corelab analyses, Charite).	24 month
Secondary	ACS-causing "culprit lesion" (OCT)	Mechanism of ACS (Plaque-Rupture vs. Plaque-Erosion vs. other mechanisms) and culprit-plaque-characteristics (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Max/Mean/minimal Mg-Stent diameter/area after implantation and lumen late loss (OCT)	Max/Mean/minimal Mg-Stent diameter/area after implantation and (in case of any clinical indicated re-angiography) lumen late loss as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Mean/minimal lumen diameter/area/volume	Mean/minimal lumen diameter/area/volume within the target lesion before and after Magmaris-Implantation, as well as (in case of any clinical indicated re-angiography) as difference Re-OCT to baseline-OCT (after Magmaris Implantation) (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Mean/minimal flow-area/volume	Mean/minimal flow-area/volume as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Intraluminal defect area/volume	Intraluminal defect area/volume at time point re-angiography/Re-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Modified vascular healing score	Modified vascular healing score (%HS; according to Räber EuroIntervention 2016; Sabate + Joner EHJ 2016) as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Presence of both malapposed and uncovered struts	Presence of both malapposed and uncovered struts (%MN) of the Mg-stent, which is an individual component of the endpoint "Healing Score" as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Presence of uncovered struts alone	Presence of both uncovered struts of the Mg-stent, which is an individual component of the endpoint "Healing Score" as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Presence of malapposed struts alone	Presence of both malapposed struts of the Mg-stent which is an individual component of the endpoint "Healing Score" as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Incomplete strut apposition (ISA) area/volume	Incomplete strut apposition (ISA) area/volume as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Percentage of covered struts	Percentage of covered struts at Re-OCT follow-up (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Mean/maximal thickness of the struts coverage	Mean/maximal thickness of the struts coverage at Re-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Neointimal hyperplasia area/volume	Neointimal hyperplasia area/volume at Re-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Thickness of neointimal tissue developed over lipid rich plaque	Thickness of neointimal tissue developed over lipid rich plaque at Re-OCT follow-up (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).	24 months
Secondary	Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG determination (MCG-substudy)	Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG determination (ST-T Score (Angle dynamic), ST-T-analysis (distance parameter and rato-dynamics), PLP2 Score, VMCG Score (T-begin till Tmax and RP ½ till Tmax), T-dispersion Score) for the vessel with target lesion compared to angiography at ACS. A comparison to exercise-ECG at 12 months will also be performed.	24 months
Secondary	Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG Determination (MCG-substudy)	Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios)of MCG determination (ST-T Score (Angle dynamic), ST-T-analysis (distance parameter and rato-dynamics) PLP2 Score, VMCG Score (T-begin till Tmax and RP ½ till Tmax), T-dispersion Score) for characteristics of the ACS-causing "culprit lesion" compared to OCT before Magmaris-Implantation.	24 months