NCT03234348

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

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

July 24, 2017

Last Update Submit

April 15, 2020

Conditions

Acute Coronary SyndromeST Segment Elevation Myocardial InfarctionStent

Keywords

biodegradable stentSTEMIMagnesium bioresorbableVasomotion

Outcome Measures

Primary Outcomes (1)

  • In-stent/scaffold vasodilatory endothelium independent response

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

    12 months follow-up

Secondary Outcomes (27)

  • Device success

    Immediate after the procedure

  • Procedure success

    Up to 7 days

  • Device-oriented Composite Endpoint (DOCE)

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

  • Cardiac death

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

  • Target vessel MI

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

  • +22 more secondary outcomes

Study Arms (2)

Magmaris

EXPERIMENTAL

Percutaneous coronary intervention by means of Magnesium-based sirolimus-eluting bioresorbable scaffold implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.

Device: Percutaneous coronary intervention

Orsiro

PLACEBO COMPARATOR

Percutaneous coronary intervention by means of Biodegradable polymer sirolimus-eluting stent implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary interventionDEVICE

PCI + stent implantation

Also known as: stent implantation
MagmarisOrsiro

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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%.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hospital General de Alicante

Alicante, Spain

Location

Hospital Clínic

Barcelona, 08036, Spain

Location

Hospital Sant Pau

Barcelona, Spain

Location

Hospital Universitari Bellvitge

Barcelona, Spain

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital La Princesa

Madrid, Spain

Location

Hospital Puerta de Hierro Majadahonda

Madrid, Spain

Location

Hospital Ramon y Cajal

Madrid, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, Spain

Location

Related Publications (3)

  • 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.

    PMID: 30196572BACKGROUND

  • 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.

    PMID: 31553204RESULT

  • 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.

    PMID: 32310130DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeST Elevation Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Manel Sabaté, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Neither the participant ot the outcomes assessor will be aware of the treatment received. The patient will be blinded until the primary endpoint is reached (1 year follow-up).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomised to one of two groups: MAGMARIS stent arm or ORSIRO stent arm in the ratio of 1:1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 31, 2017

Study Start

July 1, 2017

Primary Completion

June 30, 2019

Study Completion

October 31, 2019

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
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

Locations

ES(11)