Registry of Patients With a Bioabsorbable Magnesium Stent Implant MAGMARIS in Usual Clinical Practice

NCT ID: NCT03413813

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 262 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-26
• Study Completion Date: 2021-06-07

Brief Summary

The safety and efficacy of percutaneous coronary revascularization has been progressively increasing since its inception, and the problem of restenosis has been minimized.

The efficacy and safety data of the Magmaris stent are quite high, in selected cases.

The objective is to evaluate the efficacy and safety of the bioabsorbable stent MAGMARIS in the percutaneous treatment of severe coronary disease (in vessels between 2.7mm and 3.75 mm) in routine clinical practice in poorly selected populations.

Detailed Description

This is a multicentre, observational, prospective registry of patients without a control group designed to evaluate the efficacy and safety of the bioabsorbable coronary device, according to the indications for use, in routine clinical practice in a consecutive number of patients undergoing percutaneous coronary intervention (PCI) in de novo coronary arteries lesions in a native coronary artery.

After the implantation of the device, a telephone or face-to-face follow-up will be carried out in the first month, at 12 months and at 24 months.

A total of 445 patients are expected to be included in the registry. Patients, will be included consecutively in each center over a year. A selection period of 23 months or until the estimated sample size has been planned, with a follow-up of two years. Subsequently, it will take at least 3 months for data analysis, another 2 months for the final report and at least 3 more months for the publication of the results for publication. This implies that the total duration of the study will be 55 months counted from the inclusion of the first patient.

The procedure will be carried out according to the usual practice of each center, paying special attention to the correct expansion of the scaffold, postdilating with non-compliant balloons when necessary.

The collection of information from the study will be carried out on a data collection template in electronic format, which will include clinical, anatomical, procedural and follow-up data; in baseline circumstances, during hospitalization, after discharge and throughout follow-up at 1, 12, and 24 months. The source documents will be the patient's medical records collected at the center.

The monitoring will be done monthly and online. Two face-to-face monitoring will be done to 20% of the patients, during the inclusion and follow-up phases. Afterwards, a face-to-face monitoring will be carried out for the closing visit.

Descriptive and univariate statistics will be performed. The primary variable is the MACE rate at 12 months, composed of cardiac death, myocardial infarction and TLR induced by ischemia (primary objectives). The secondary variables will be combined indices of events both in the hospital phase, and after discharge in the follow-up at 1, 12 and 24 months.

A final report will be prepared containing all the results of the study, in a period of 6 months once the same one finalized. The participating researchers and the Ethical Committees of the hospitals will be informed about this.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Magmaris

Severe stenosis de novo, in native coronary arteries, treated with percutaneous coronary intervention with scaffold implantation.

Intervention Type: DEVICE

Other Intervention Names

Bioresorbable scaffold

Eligibility Criteria

Inclusion Criteria

• BASIC CRITERIA:

• Patients who agree to participate in the study, signing the informed consent form.
• The implantation of the bioresorbable MAGMARIS coronary device used according to the indications for use in the center's routine clinical practice.
• Patients of both sexes over 18 years of age.
• The patient does not present any contraindication regarding the taking of dual therapy of antiplatelet therapy with aspirin indefinitely and with thienopyridines for at least the first 6 months.
• CLINICAL CRITERIA:

• Angor stable or anginal equivalent diagnosis of stable chronic ischemic heart disease.
• Documented silent ischemia
• Acute coronary syndrome (excluding AMI with ST-segment elevation <24 hours)
• Angina Equivalent
• ANGIOGRAPHICAL CRITERIA:

• One or more de novo lesions (stenosis> 70% by visual estimation or> 50% by estimation of quantitative automatic angiography) in native coronary arteries.
• Vessel reference diameter ≥2.7 and ˂3.75.
• Maximum length of the lesion to be treated must be less than the nominal length of the device (15 mm, 20 mm, 25 mm) or capable of being covered with more than one scaffold implanted in an overlapped manner by at least 1 mm with respect to the adjacent.

Exclusion Criteria

• CLINICS:

• Cardiogenic shock
• Acute Myocardial Infarction (first 24 hours).
• Concurrent diseases with life expectancy of less than 1 year
• Women of reproductive age who do not use contraception.
• Women who are pregnant or breast-feeding.
• Allergies: AAS, Thienopyridines, Magnesium.
• ANATOMICS:

• Main coronary artery lesion
• Lesion in aorto-coronary graft of saphenous vein or mammary artery.
• Intra-stent restenosis lesion.
• Lesion chronic total occlusion.
• Bifurcation lesion
• Severely calcified or severely tortuous coronary artery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Society of Cardiology

OTHER

Sponsor Role: lead

Responsible Party

Andres Iñiguez Romo, MD

Head of cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andres I Romo, MD, PhD

Role: STUDY_DIRECTOR

Spanish Society of Cardiology

Locations

Hospital Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Mutua de Terrassa

Terrassa, Barcelona, Spain

Hospital Universitario General de Castellón

Castellon, Castellón, Spain

Hospital Universitario Puerto Real

Puerto Real, Cádiz, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Universitario Santa Lucía

Cartagena, Murcia, Spain

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital Universitario Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital Universitario de Cruces

Barakaldo, Vizcaya, Spain

Hospital Universitario de Basurto

Bilbao, Vizcaya, Spain

Hospital Universitario Infanta Cristina

Badajoz, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitario Vall d´Hebron

Barcelona, , Spain

Hospital Universitario Clinic de Barcelona

Barcelona, , Spain

Hospital Universitario Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Puerta del Mar

Cadiz, , Spain

Hospital Universitario San Pedro de Alcántara

Cáceres, , Spain

Hospital Universitario General de Ciudad Real

Ciudad Real, , Spain

Hospital Universitario Doctor Josep Trueta

Girona, , Spain

Hospital San Cecilio-Campus de la Salud

Granada, , Spain

Hospital Universitario Arnau de Vilanova

Lleida, , Spain

Hospital Universitario Lucus Augusti

Lugo, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Hospital Universitario Clínico de Valencia

Valencia, , Spain

Hospital Universitario General de Valencia

Valencia, , Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Hospital Universitario de Áraba

Vitoria-Gasteiz, Álava, Spain

Countries

Spain

Other Identifiers

MAGMARIS-ES

Identifier Type: -

Identifier Source: org_study_id