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Acute Coronary SyndromeSOLVE-ACSNCT03773081

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

A study testing Implantation of the Magmaris scaffold in people with Acute Coronary Syndrome and STEMI - ST Elevation Myocardial Infarction, run by Charite University, Berlin, Germany at 4 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Implantation of the Magmaris scaffold
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
4 sitesGermany
Study dates
21 Aug 2018to 15 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 22Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen

  • Vivantes Klinikum im Friedrichshain

    Berlin, 10249

  • Charité Universitätsmedizin Berlin

    Berlin, 12203

  • Universitätsklinikum Johannes Wesling

    Minden

Other trials in Germany

About this study

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

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

Read the 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.

Being tested
Implantation of the Magmaris scaffold
Keywords
Acute Coronary Syndrome, STE-ACS, NSTE-ACS, Magmaris
Medical subject headings
Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantation of the Magmaris scaffoldDevice

    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.

Study groups in NCT03773081
Study groupRoleWhat they receive
Magmaris implantationOtherSubjects will undergo a PCI for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice.
Receives: Device: Implantation of the Magmaris scaffold

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At the end of PCI

Secondary outcomes (31)

  1. ST-segment resolution at the electrocardiogram (ECG)

    ST-segment resolution at ECG.

    Measured: Within 60 minutes of primary PCI

  2. Procedural clinical success within hospital stay

    No in-hospital clinically-driven target lesion revascularization.

    Measured: Until hospital discharge, an expected average of 4 days

  3. 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.

    Measured: 6 months, 12 months and 2 years

  4. 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.

    Measured: 6 months, 12 months and 2 years

  5. 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).

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

  6. All-cause death at all time points

    Clinical Endpoint (in-hospital and at follow-up (6 months, 12 months, 2 years).

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

  7. Cardiac death at all time points

    Clinical Endpoint (in-hospital and at follow-up (6 months, 12 months, 2 years).

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

  8. Magmaris Thrombosis

    Any definite/probable per ARC defintion Magmaris thrombosis (in-hospital and during follow-up (6 months, 12 months, 2 years).

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

  9. 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).

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

  10. 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).

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

  11. Stable angina

    Angina as assessed by Seattle angina score (SAS) at follow-up (6 months, 12 months, 2 years).

    Measured: 6 months, 12 months and 2 years

  12. Evidence for myocardial ischemia

    Clinical or ECG-signs for myocardial ischemia during exercise ECG at 12-month follow-up.

    Measured: 12 months

  13. 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).

    Measured: 24 months

  14. 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).

    Measured: 24 months

  15. TIMI-flow

    TIMI-flow before (after mechanical recanalization) and after Magmaris Implantation (assessed by outcome-blinded Corelab analyses, Charite).

    Measured: 24 month

  16. 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).

    Measured: 24 months

  17. 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).

    Measured: 24 months

  18. 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).

    Measured: 24 months

  19. 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).

    Measured: 24 months

  20. 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).

    Measured: 24 months

  21. 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).

    Measured: 24 months

  22. 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).

    Measured: 24 months

  23. 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).

    Measured: 24 months

  24. 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).

    Measured: 24 months

  25. 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).

    Measured: 24 months

  26. 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).

    Measured: 24 months

  27. 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).

    Measured: 24 months

  28. 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).

    Measured: 24 months

  29. 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).

    Measured: 24 months

  30. 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.

    Measured: 24 months

  31. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2018
  2. Study start21 Aug 2018
  3. Primary completion15 Sep 2019
  4. Study completion15 Sep 2019

Why it stopped: Low recruitment rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03773081
Sponsor's protocol ID
4.1
Acronym
SOLVE-ACS
Status last verified
Sep 2019
First submitted
9 Dec 2018
Last updated
17 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Implantation of the Magmaris scaffold in people with Acute Coronary Syndrome and STEMI - ST Elevation Myocardial Infarction, run by Charite University, Berlin, Germany at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural angiographical success (time frame: At the end of PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03773081.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.

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