MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction

Acute Coronary Syndrome Clinical Trial

— MAGSTEMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234348
• Other study ID #: MAG-01
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST Segment Elevation Myocardial Infarction
• Stent

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