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

NCT03413813 | Completed DMC

• 1 other identifier: MAGMARIS-ES
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 31

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.

Conditions

Coronary Artery Disease

Keywords

Magmaris

Outcome Measures

Primary Outcomes (3)

• A combined rate (incidence of events) of:

  The cardiac death (incidence of events).

  12 months

• A combined rate (incidence of events) of:

  Myocardial infarction (incidence of events)

  12 months

• A combined rate (incidence of events) of:

  Revascularization of the treated lesion (TLR) induced by ischemia (incidence of events)

  12 months

Secondary Outcomes (14)

• The event rate will be calculated for:

  24 months

• The event rate will be calculated for:

  24 months

• The event rate will be calculated for:

  24 months

• The event rate will be calculated for:

  24 months

• The event rate will be calculated for:

  24 months

Interventions

Magmaris DEVICE

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

Also known as: Bioresorbable scaffold

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with ischemic heart disease by de novo lesions in native coronary arteries, candidates for revascularization with coronary stent.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish Society of Cardiology: lead

Study Sites (31)

Hospital Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitario General de Castellón

Castellon, Castellón, 12004, Spain

Location

Hospital Universitario Puerto Real

Puerto Real, Cádiz, 11510, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Santa Lucía

Cartagena, Murcia, 30202, Spain

Location

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Universitario Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Universitario de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Hospital Universitario Infanta Cristina

Badajoz, 06080, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitario Vall d´Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Universitario San Pedro de Alcántara

Cáceres, 10003, Spain

Location

Hospital Universitario General de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Universitario Doctor Josep Trueta

Girona, 17007, Spain

Location

Hospital San Cecilio-Campus de la Salud

Granada, 18016, Spain

Location

Hospital Universitario Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Clínico de Valencia

Valencia, 46010, Spain

Location

Hospital Universitario General de Valencia

Valencia, 46014, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital Universitario de Áraba

Vitoria-Gasteiz, Álava, 01009, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Andres I Romo, MD, PhD

  Spanish Society of Cardiology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of cardiology

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 29, 2018
• Study Start: July 26, 2017
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

ES (31)