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Acute Coronary SyndromePhase 3MAGSTEMINCT03234348

MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction

A Phase 3 study testing Percutaneous coronary intervention in people with Acute Coronary Syndrome and ST Segment Elevation Myocardial Infarction, run by Hospital Clinic of Barcelona at 11 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, randomized, active control, single-blind, non-inferiority, multicenter clinical trial. 148 subjects will be registered at up to 10 Spanish sites. Subjects will be followed for 5 years. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Percutaneous coronary intervention
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
151 participants
Where
11 sitesSpain
Study dates
1 Jul 2017to 31 Oct 2019
Phase
Phase 3
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical:
  • At least 18 years of age.
  • ST-segment elevation Myocardial Infarction documented in an ambulance or in a Cathlab, with ≥2 mm ST segment elevation in at least two contiguous leads, presenting in the Cathlab <12 hours after the onset of symptoms lasting ≥20 min requiring primary PCI.
  • Target lesion must be a de-novo lesion located in a native vessel.
  • The patient accepts Informed Consent
  • The patient understands and accepts clinical follow-up and angiographic control.
Show all 9Show fewer
  • Angiographic:
  • Vessel size should match available M-BRS scaffold sizes (≥2.75 mm, and ≤3.7 mm by visual assessment).
  • Lesion preparation by either manual thrombectomy or pre-dilatation has been successful, with opening of the vessel and TIMI ≥2 and residual stenosis <20%.

Who cannot join

  • Pregnancy.
  • Known intolerance to aspirin, heparin, stainless steel, sirolimus, and contrast material.
  • Distal vessel occlusion after recanalization
  • STEMI due to stent/scaffold thrombosis
  • Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal m-BRS placement.
  • Fibrinolysis prior to PCI
Show all 13Show fewer
  • Known thrombocytopenia (PLT< 100,000/mm3)
  • Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
  • Cardiogenic Shock
  • Significant comorbidities precluding clinical/angiographic FU (as judged by investigators)
  • Major planned surgery that requires discontinuation of dual antiplatelet therapy.
  • Diffuse coronary artery disease that will require CABG
  • Chronic kidney disease with GFR<30 ml/min

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Spain11 sites

  • Hospital General de Alicante

    Alicante

  • Hospital Clínic

    Barcelona, 08036

  • Hospital Sant Pau

    Barcelona

  • Hospital Universitari Bellvitge

    Barcelona

  • Hospital Vall d'Hebron

    Barcelona

  • Hospital San Pedro de Alcántara

    Cáceres

  • Hospital Clínico San Carlos

    Madrid

  • Hospital La Princesa

    Madrid

  • Hospital Puerta de Hierro Majadahonda

    Madrid

  • Hospital Ramon y Cajal

    Madrid

  • Hospital Alvaro Cunqueiro

    Vigo

Other trials in Spain

About this study

Official title: MAGnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients With Acute ST Segment Elevation Myocardial Infarction

This is a prospective, randomized, active control, single-blind, non-inferiority, multicenter clinical trial. 148 subjects will be registered at up to 10 Spanish sites. Subjects will be followed for 5 years.

All eligible patients (STEMI < 12 hours from onset of chest pain) will be randomized to

Read more
  • Biotronik MAGMARISTM Sirolimus Eluting Bioresorbable Vascular Scaffold System (M-BRS) or
  • Biotronik ORSIRO Sirolimus Eluting Coronary Stent System

Endothelium-independent vasomotor response (NTG injection) will be analyzed at 12 months angiographic follow-up (Primary endpoint).

In a subgroup of 40 patients Optical Coherence Tomography will be performed after the procedure and at 12 months follow-up.

Angiographic (QCA pre- and post-procedure and at 12 months follow-up), OCT data (at 12 months follow-up) will be analyzed off-line by an independent core lab.

Being tested
Percutaneous coronary intervention
Keywords
biodegradable stent, STEMI, Magnesium bioresorbable, Vasomotion
Medical subject headings
Acute Coronary Syndrome, ST Elevation Myocardial Infarction

What participants receive

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

  • Percutaneous coronary interventionDevice

    Also called stent implantation

    PCI + stent implantation

Study groups in NCT03234348
Study groupRoleWhat they receive
MagmarisExperimentalPercutaneous coronary intervention by means of Magnesium-based sirolimus-eluting bioresorbable scaffold implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.
Receives: Device: Percutaneous coronary intervention
OrsiroPlacebo comparatorPercutaneous coronary intervention by means of Biodegradable polymer sirolimus-eluting stent implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.
Receives: Device: Percutaneous coronary intervention

What is being measured

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

  1. In-stent/scaffold vasodilatory endothelium independent response

    in-stent/scaffold vasodilatory response ≥3% (delta in mean lumen diameter) after nitroglycerin injection

    Measured: 12 months follow-up

Secondary outcomes (27)

  1. Device success

    implantation of the intended device with attainment of <30% residual stenosis of the target lesion and TIMI ≥2

    Measured: Immediate after the procedure

  2. Procedure success

    device success and no in-hospital cardiac events: death, repeat MI, TVR or stent/scaffold thrombosis

    Measured: Up to 7 days

  3. Device-oriented Composite Endpoint (DOCE)

    Combined of cardiac death, Target vessel MI, or clinically-indicated target lesion revascularization

    Measured: 1, 6 months, 1,2,3,4,5 years

  4. Cardiac death

    ARC definition

    Measured: 1, 6 months, 1,2,3,4,5 years

  5. Target vessel MI

    ARC definition

    Measured: 1, 6 months, 1,2,3,4,5 years

  6. Clinically driven target lesion revascularization

    ARC definition-Ischemia driven revascularization

    Measured: 1, 6 months, 1,2,3,4,5 years

  7. Stent/scaffold thrombosis

    ARC definition: definite, probable, possible, acute, subacute, late and very late

    Measured: 1, 6 months, 1,2,3,4,5 years

  8. Patient oriented endpoint (POCE)

    Combined of all-cause death, any repeat myocardial infarction and any revascularization

    Measured: 1, 6 months, 1,2,3,4,5 years

  9. All-cause death

    All-cause death rate

    Measured: 1, 6 months, 1,2,3,4,5 years

  10. Any repeat myocardial infarction

    According to WHO extended definition

    Measured: 1, 6 months, 1,2,3,4,5 years

  11. Any revascularization

    Any repeat intervention in the patient

    Measured: 1, 6 months, 1,2,3,4,5 years

  12. Target lesion revascularization

    ARC definition

    Measured: 1, 6 months, 1,2,3,4,5 years

  13. Target vessel revascularization

    ARC definition

    Measured: 1, 6 months, 1,2,3,4,5 years

  14. MLD

    Minimal lumen diameter by QCA

    Measured: Baseline and 1 year follow-up

  15. %DS

    percentage diameter stenosis by QCA

    Measured: Baseline and 1 year follow-up

  16. Acute gain

    MLD post - MLD pre by QCA

    Measured: Baseline

  17. Late loss

    MLD post - MLD at 1 year follow-up by QCA

    Measured: 1 year

  18. Binary restenosis

    % of patients with >50% DS at 1 year follow-up by QCA

    Measured: 1 year

  19. Lumen area

    Mean and minimum lumen area of the stented/scaffolded segment by OCT

    Measured: 1 year follow-up

  20. Mean lumen volume

    mean lumen volume of the stented/scaffolded segment by OCT

    Measured: 1 year follow-up

  21. % strut malapposition

    mean area of strut malapposition by OCT

    Measured: 1 year follow-up

  22. Tissue Prolapse

    presence and % of lumen area occupied by tissue prolapse by OCT

    Measured: 1 year follow-up

  23. Neointimal hyperplasia

    mean intra-stent/scaffold area occupied by neointimal hyperplasia by OCT

    Measured: 1 year follow-up

  24. Healing index

    Index obtained by a combination of % malapposition, % coverage, % tissue prolapse by OCT

    Measured: 1 year follow-up

  25. Strut coverage

    Presence and amount of tissue covering the strut of the stent/scaffold by OCT

    Measured: 1 year follow-up

  26. RUTTS

    Ratio of Uncovered to Total Stent/scaffold Struts Per Cross Section (RUTTS) score of ≤30% of the target stent/scaffold as determined by OCT pullback

    Measured: 1 year follow-up

  27. in-stent/in-scaffold endothelium-dependent vasomotion

    % change in mean luminal dimeter on the treated segment after acetylcholine infusion

    Measured: at 12 months

Timeline

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

  1. First posted31 Jul 2017
  2. Study start1 Jul 2017
  3. Primary completion30 Jun 2019
  4. Study completion31 Oct 2019

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomised to one of two groups: MAGMARIS stent arm or ORSIRO stent arm in the ratio of 1:1
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03234348
Sponsor's protocol ID
MAG-01
Acronym
MAGSTEMI
Status last verified
Apr 2020
First submitted
24 Jul 2017
Last updated
17 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data on primary/secondary outcomes on individual basis may be shared with other researchers once main report as been published and review and approval of the research proposal by the steering committee of the Magstemi Trial

Publications

  • Brugaletta S, Cequier A, Alfonso F, Iniguez A, Romani S, Serra A, Salinas P, Goicolea J, Bordes P, Del Blanco BG, Hernandez-Antolin R, Pernigotti A, Gomez-Lara J, Sabate M. MAGnesium-based bioresorbable scaffold and vasomotor function in patients with acute ST segment elevation myocardial infarction: The MAGSTEMI trial: Rationale and design. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):64-70. doi: 10.1002/ccd.27825. Epub 2018 Sep 9.

    PubMed 30196572

  • Sabate M, Alfonso F, Cequier A, Romani S, Bordes P, Serra A, Iniguez A, Salinas P, Garcia Del Blanco B, Goicolea J, Hernandez-Antolin R, Cuesta J, Gomez-Hospital JA, Ortega-Paz L, Gomez-Lara J, Brugaletta S. Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial. Circulation. 2019 Dec 3;140(23):1904-1916. doi: 10.1161/CIRCULATIONAHA.119.043467. Epub 2019 Sep 25.

    PubMed 31553204

  • Gomez-Lara J, Ortega-Paz L, Brugaletta S, Cuesta J, Romani S, Serra A, Salinas P, Garcia Del Blanco B, Goicolea J, Hernandez-Antolin R, Antuna P, Romaguera R, Regueiro A, Rivero F, Cequier A, Alfonso F, Gomez-Hospital JA, Sabate M; Collaborators. Bioresorbable scaffolds versus permanent sirolimus-eluting stents in patients with ST-segment elevation myocardial infarction: vascular healing outcomes from the MAGSTEMI trial. EuroIntervention. 2020 Dec 4;16(11):e913-e921. doi: 10.4244/EIJ-D-20-00198.

    PubMed 32310130

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Percutaneous coronary intervention in people with Acute Coronary Syndrome and ST Segment Elevation Myocardial Infarction, run by Hospital Clinic of Barcelona at 11 sites in Spain.

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 9 inclusion and 13 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: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

In-stent/scaffold vasodilatory endothelium independent response (time frame: 12 months follow-up). 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 NCT03234348, which also lists 3 linked publications.

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 Apr 2020.

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MAGSTEMI Clinical Trial NCT03234348 | AzTrials