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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773081
Recruitment Status : Terminated (Low recruitment rate)
First Posted : December 12, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
David Manuel Leistner, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome STEMI - ST Elevation Myocardial Infarction NSTEMI - Non-ST Segment Elevation MI Device: Implantation of the Magmaris scaffold Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SOLVE-ACS: Prospective Multicenter Evaluation of the Performance of the Bioresorbable Magnesium-Stents Magmaris in Patients With Acute Coronary Syndrome (ACS)
Actual Study Start Date : August 21, 2018
Actual Primary Completion Date : September 15, 2019
Actual Study Completion Date : September 15, 2019

Arm Intervention/treatment
Magmaris implantation
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
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. ST-segment resolution at the electrocardiogram (ECG) [ Time Frame: Within 60 minutes of primary PCI ]
    ST-segment resolution at ECG.

  2. Procedural clinical success within hospital stay [ Time Frame: Until hospital discharge, an expected average of 4 days ]
    No in-hospital clinically-driven target lesion revascularization.

  3. Target lesion revascularization [ Time Frame: 6 months, 12 months and 2 years ]
    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.

  4. Device-oriented composite endpoint (DOCE) [ Time Frame: 6 months, 12 months and 2 years ]
    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.

  5. Major adverse cardiovascular events (MACE) [ Time Frame: Until hospital discharge, 6 months, 12 months and 2 years ]
    Cardiac death, any TV-MI, target vessel revascularization (TVR) in-hospital or during follow-up (6 months, 12 months, 2 years).

  6. All-cause death at all time points [ Time Frame: Until hospital discharge, 6 months, 12 months and 2 years ]
    Clinical Endpoint (in-hospital and at follow-up (6 months, 12 months, 2 years).

  7. Cardiac death at all time points [ Time Frame: Until hospital discharge, 6 months, 12 months and 2 years ]
    Clinical Endpoint (in-hospital and at follow-up (6 months, 12 months, 2 years).

  8. Magmaris Thrombosis [ Time Frame: Until hospital discharge, 6 months, 12 months and 2 years ]
    Any definite/probable per ARC defintion Magmaris thrombosis (in-hospital and during follow-up (6 months, 12 months, 2 years).

  9. Any Bleeding [ Time Frame: Until hospital discharge, 6 months, 12 months and 2 years ]
    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).

  10. Vascular cerebral events [ Time Frame: Until hospital discharge, 6 months, 12 months and 2 years ]
    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).

  11. Stable angina [ Time Frame: 6 months, 12 months and 2 years ]
    Angina as assessed by Seattle angina score (SAS) at follow-up (6 months, 12 months, 2 years).

  12. Evidence for myocardial ischemia [ Time Frame: 12 months ]
    Clinical or ECG-signs for myocardial ischemia during exercise ECG at 12-month follow-up.

  13. Percent diameter stenosis [ Time Frame: 24 months ]
    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).

  14. Minimal Lumen Diameter (MLD) [ Time Frame: 24 months ]
    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).

  15. TIMI-flow [ Time Frame: 24 month ]
    TIMI-flow before (after mechanical recanalization) and after Magmaris Implantation (assessed by outcome-blinded Corelab analyses, Charite).

  16. ACS-causing "culprit lesion" (OCT) [ Time Frame: 24 months ]
    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).

  17. Max/Mean/minimal Mg-Stent diameter/area after implantation and lumen late loss (OCT) [ Time Frame: 24 months ]
    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).

  18. Mean/minimal lumen diameter/area/volume [ Time Frame: 24 months ]
    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).

  19. Mean/minimal flow-area/volume [ Time Frame: 24 months ]
    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).

  20. Intraluminal defect area/volume [ Time Frame: 24 months ]
    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).

  21. Modified vascular healing score [ Time Frame: 24 months ]
    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).

  22. Presence of both malapposed and uncovered struts [ Time Frame: 24 months ]
    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).

  23. Presence of uncovered struts alone [ Time Frame: 24 months ]
    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. Presence of malapposed struts alone [ Time Frame: 24 months ]
    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).

  25. Incomplete strut apposition (ISA) area/volume [ Time Frame: 24 months ]
    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).

  26. Percentage of covered struts [ Time Frame: 24 months ]
    Percentage of covered struts at Re-OCT follow-up (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).

  27. Mean/maximal thickness of the struts coverage [ Time Frame: 24 months ]
    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).

  28. Neointimal hyperplasia area/volume [ Time Frame: 24 months ]
    Neointimal hyperplasia area/volume at Re-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).

  29. Thickness of neointimal tissue developed over lipid rich plaque [ Time Frame: 24 months ]
    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).

  30. Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG determination (MCG-substudy) [ Time Frame: 24 months ]
    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.

  31. Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG Determination (MCG-substudy) [ Time Frame: 24 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773081


Locations
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Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
Charité Universitätsmedizin Berlin
Berlin, Germany, 12203
Universitätsklinikum Johannes Wesling
Minden, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Ulf Landmesser, Prof. Dr. Charite University, Berlin, Germany
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Responsible Party: David Manuel Leistner, Coordinating Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03773081    
Other Study ID Numbers: 4.1
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Manuel Leistner, Charite University, Berlin, Germany:
Acute Coronary Syndrome
STE-ACS
NSTE-ACS
Magmaris
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Syndrome
Infarction
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases