Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03234348
Other study ID # MAG-01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 1, 2017
Est. completion date October 31, 2019

Study information

Verified date April 2020
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.


Recruitment information / eligibility

Status Completed
Enrollment 151
Est. completion date October 31, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

Clinical:

1. At least 18 years of age.

2. 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.

3. Target lesion must be a de-novo lesion located in a native vessel.

4. The patient accepts Informed Consent

5. The patient understands and accepts clinical follow-up and angiographic control.

Angiographic:

6. Vessel size should match available M-BRS scaffold sizes (=2.75 mm, and =3.7 mm by visual assessment).

7. Lesion preparation by either manual thrombectomy or pre-dilatation has been successful, with opening of the vessel and TIMI =2 and residual stenosis <20%.

Exclusion Criteria:

1. Pregnancy.

2. Known intolerance to aspirin, heparin, stainless steel, sirolimus, and contrast material.

3. Distal vessel occlusion after recanalization

4. STEMI due to stent/scaffold thrombosis

5. 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.

6. Fibrinolysis prior to PCI

7. Known thrombocytopenia (PLT< 100,000/mm3)

8. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy

9. Cardiogenic Shock

10. Significant comorbidities precluding clinical/angiographic FU (as judged by investigators)

11. Major planned surgery that requires discontinuation of dual antiplatelet therapy.

12. Diffuse coronary artery disease that will require CABG

13. Chronic kidney disease with GFR<30 ml/min

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Percutaneous coronary intervention
PCI + stent implantation

Locations

Country Name City State
Spain Hospital General de Alicante Alicante
Spain Hospital Clínic Barcelona
Spain Hospital Sant Pau Barcelona
Spain Hospital Universitari Bellvitge Barcelona
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital San Pedro de Alcántara Cáceres
Spain Hospital Clínico San Carlos Madrid
Spain Hospital La Princesa Madrid
Spain Hospital Puerta de Hierro Majadahonda Madrid
Spain Hospital Ramon y Cajal Madrid
Spain Hospital Alvaro Cunqueiro Vigo

Sponsors (2)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona Spanish Society of Cardiology

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Brugaletta S, Cequier A, Alfonso F, Iñiguez A, Romaní S, Serra A, Salinas P, Goicolea J, Bordes P, Del Blanco BG, Hernández-Antolín R, Pernigotti A, Gómez-Lara J, Sabaté 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. — View Citation

Sabaté M, Alfonso F, Cequier A, Romaní S, Bordes P, Serra A, Iñiguez A, Salinas P, García Del Blanco B, Goicolea J, Hernández-Antolín R, Cuesta J, Gómez-Hospital JA, Ortega-Paz L, Gomez-Lara J, Brugaletta S. Magnesium-Based Resorbable Scaffold Versus Perm — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Device success implantation of the intended device with attainment of <30% residual stenosis of the target lesion and TIMI =2 Immediate after the procedure
Secondary Procedure success device success and no in-hospital cardiac events: death, repeat MI, TVR or stent/scaffold thrombosis Up to 7 days
Secondary Device-oriented Composite Endpoint (DOCE) Combined of cardiac death, Target vessel MI, or clinically-indicated target lesion revascularization 1, 6 months, 1,2,3,4,5 years
Secondary Cardiac death ARC definition 1, 6 months, 1,2,3,4,5 years
Secondary Target vessel MI ARC definition 1, 6 months, 1,2,3,4,5 years
Secondary Clinically driven target lesion revascularization ARC definition-Ischemia driven revascularization 1, 6 months, 1,2,3,4,5 years
Secondary Stent/scaffold thrombosis ARC definition: definite, probable, possible, acute, subacute, late and very late 1, 6 months, 1,2,3,4,5 years
Secondary Patient oriented endpoint (POCE) Combined of all-cause death, any repeat myocardial infarction and any revascularization 1, 6 months, 1,2,3,4,5 years
Secondary All-cause death All-cause death rate 1, 6 months, 1,2,3,4,5 years
Secondary Any repeat myocardial infarction According to WHO extended definition 1, 6 months, 1,2,3,4,5 years
Secondary Any revascularization Any repeat intervention in the patient 1, 6 months, 1,2,3,4,5 years
Secondary Target lesion revascularization ARC definition 1, 6 months, 1,2,3,4,5 years
Secondary Target vessel revascularization ARC definition 1, 6 months, 1,2,3,4,5 years
Secondary MLD Minimal lumen diameter by QCA Baseline and 1 year follow-up
Secondary %DS percentage diameter stenosis by QCA Baseline and 1 year follow-up
Secondary Acute gain MLD post - MLD pre by QCA Baseline
Secondary Late loss MLD post - MLD at 1 year follow-up by QCA 1 year
Secondary Binary restenosis % of patients with >50% DS at 1 year follow-up by QCA 1 year
Secondary Lumen area Mean and minimum lumen area of the stented/scaffolded segment by OCT 1 year follow-up
Secondary Mean lumen volume mean lumen volume of the stented/scaffolded segment by OCT 1 year follow-up
Secondary % strut malapposition mean area of strut malapposition by OCT 1 year follow-up
Secondary Tissue Prolapse presence and % of lumen area occupied by tissue prolapse by OCT 1 year follow-up
Secondary Neointimal hyperplasia mean intra-stent/scaffold area occupied by neointimal hyperplasia by OCT 1 year follow-up
Secondary Healing index Index obtained by a combination of % malapposition, % coverage, % tissue prolapse by OCT 1 year follow-up
Secondary Strut coverage Presence and amount of tissue covering the strut of the stent/scaffold by OCT 1 year follow-up
Secondary 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 1 year follow-up
Secondary in-stent/in-scaffold endothelium-dependent vasomotion % change in mean luminal dimeter on the treated segment after acetylcholine infusion at 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06013813 - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI N/A
Recruiting NCT05412927 - AngelMed Guardian® System PMA Post Approval Study
Completed NCT02750579 - Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes? N/A
Completed NCT04102410 - Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients N/A
Enrolling by invitation NCT03342131 - Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome N/A
Recruiting NCT01218776 - International Survey of Acute Coronary Syndromes in Transitional Countries
Enrolling by invitation NCT04676100 - International CR Registry
Completed NCT03590535 - 5th Generation cTnT in ED ACS
Recruiting NCT05437900 - INSIGHTFUL-FFR Clinical Trial Phase 4
Completed NCT05551429 - Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
Terminated NCT04316481 - IDE-ALERTS Continued Access Study N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting NCT04852146 - Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.
Active, not recruiting NCT02892903 - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes? N/A
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Completed NCT02944123 - Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR) Phase 3
Completed NCT04077229 - Piloting Text Messages to Promote Positive Affect and Physical Activity N/A
Active, not recruiting NCT02922140 - The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit N/A
Completed NCT02673437 - Rivaroxaban ACS Specialist Cohort Event Monitoring Study