MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction

Phase 3

Completed

• Conditions: ST Segment Elevation Myocardial Infarction; Stent; Acute Coronary Syndrome
• Interventions: Device: Percutaneous coronary intervention

• Registration Number: NCT03234348
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-31
• Primary Completion: 2019-06-30
• Study Completion: 2019-10-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magmaris	Percutaneous coronary intervention	Percutaneous coronary intervention by means of Magnesium-based sirolimus-eluting bioresorbable scaffold implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.
Orsiro	Percutaneous coronary intervention	Percutaneous coronary intervention by means of Biodegradable polymer sirolimus-eluting stent implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.

Primary Outcome Measures

Name	Time	Method
In-stent/scaffold vasodilatory endothelium independent response	12 months follow-up	in-stent/scaffold vasodilatory response ≥3% (delta in mean lumen diameter) after nitroglycerin injection

Secondary Outcome Measures

Name	Time	Method
Target vessel revascularization	1, 6 months, 1,2,3,4,5 years	ARC definition
Tissue Prolapse	1 year follow-up	presence and % of lumen area occupied by tissue prolapse by OCT
Procedure success	Up to 7 days	device success and no in-hospital cardiac events: death, repeat MI, TVR or stent/scaffold thrombosis
Cardiac death	1, 6 months, 1,2,3,4,5 years	ARC definition
Target vessel MI	1, 6 months, 1,2,3,4,5 years	ARC definition
Clinically driven target lesion revascularization	1, 6 months, 1,2,3,4,5 years	ARC definition-Ischemia driven revascularization
% strut malapposition	1 year follow-up	mean area of strut malapposition by OCT
Device success	Immediate after the procedure	implantation of the intended device with attainment of \<30% residual stenosis of the target lesion and TIMI ≥2
Patient oriented endpoint (POCE)	1, 6 months, 1,2,3,4,5 years	Combined of all-cause death, any repeat myocardial infarction and any revascularization
Acute gain	Baseline	MLD post - MLD pre by QCA
Binary restenosis	1 year	% of patients with \>50% DS at 1 year follow-up by QCA
Mean lumen volume	1 year follow-up	mean lumen volume of the stented/scaffolded segment by OCT
Neointimal hyperplasia	1 year follow-up	mean intra-stent/scaffold area occupied by neointimal hyperplasia by OCT
RUTTS	1 year follow-up	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
Stent/scaffold thrombosis	1, 6 months, 1,2,3,4,5 years	ARC definition: definite, probable, possible, acute, subacute, late and very late
All-cause death	1, 6 months, 1,2,3,4,5 years	All-cause death rate
Any repeat myocardial infarction	1, 6 months, 1,2,3,4,5 years	According to WHO extended definition
Target lesion revascularization	1, 6 months, 1,2,3,4,5 years	ARC definition
Lumen area	1 year follow-up	Mean and minimum lumen area of the stented/scaffolded segment by OCT
Device-oriented Composite Endpoint (DOCE)	1, 6 months, 1,2,3,4,5 years	Combined of cardiac death, Target vessel MI, or clinically-indicated target lesion revascularization
Any revascularization	1, 6 months, 1,2,3,4,5 years	Any repeat intervention in the patient
MLD	Baseline and 1 year follow-up	Minimal lumen diameter by QCA
%DS	Baseline and 1 year follow-up	percentage diameter stenosis by QCA
Strut coverage	1 year follow-up	Presence and amount of tissue covering the strut of the stent/scaffold by OCT
in-stent/in-scaffold endothelium-dependent vasomotion	at 12 months	% change in mean luminal dimeter on the treated segment after acetylcholine infusion
Healing index	1 year follow-up	Index obtained by a combination of % malapposition, % coverage, % tissue prolapse by OCT
Late loss	1 year	MLD post - MLD at 1 year follow-up by QCA

Trial Locations

Locations (11)

Hospital General de Alicante; 🇪🇸 Alicante, Spain

Hospital Clínic; 🇪🇸 Barcelona, Spain

Hospital Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital San Pedro de Alcántara; 🇪🇸 Cáceres, Spain

Hospital Universitari Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital La Princesa; 🇪🇸 Madrid, Spain

Hospital Puerta de Hierro Majadahonda; 🇪🇸 Madrid, Spain

Hospital Alvaro Cunqueiro; 🇪🇸 Vigo, Spain