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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Magmaris

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.

• Study Type: Observational
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain, 06080
    • Hospital Universitario Infanta Cristina
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d´Hebron
  • Barcelona, Spain, 08036
    • Hospital Universitario Clínic de Barcelona
  • Barcelona, Spain, 08041
    • Hospital Universitario Santa Creu i Sant Pau
  • Ciudad Real, Spain, 13005
    • Hospital Universitario General de Ciudad Real
  • Cáceres, Spain, 10003
    • Hospital Universitario San Pedro de Alcantara
  • Cádiz, Spain, 11009
    • Hospital Universitario Puerta del Mar
  • Gerona, Spain, 17007
    • Hospital Universitario Doctor Josep Trueta
  • Granada, Spain, 18016
    • Hospital San Cecilio-Campus de la Salud
  • Lleida, Spain, 25198
    • Hospital Universitario Arnau de Vilanova
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Valencia, Spain, 46010
    • Hospital Universitario Clínico de Valencia
  • Valencia, Spain, 46014
    • Hospital Universitario General de Valencia
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa
  • A Coruña
    • Santiago De Compostela, A Coruña, Spain, 15706
      • Hospital Universitario de Santiago de Compostela
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario de Bellvitge
    • Terrassa, Barcelona, Spain, 08221
      • Hospital Universitario Mutua de Terrassa
  • Castellón
    • Castellón De La Plana, Castellón, Spain, 12004
      • Hospital Universitario General de Castellón
  • Cádiz
    • Puerto Real, Cádiz, Spain, 11510
      • Hospital Universitario Puerto Real
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07120
      • Hospital Universitario Son Espases
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro
  • Murcia
    • Cartagena, Murcia, Spain, 30202
      • Hospital Universitario Santa Lucía
    • El Palmar, Murcia, Spain, 30120
      • Hospital Universitario Virgen de la Arrixaca
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Hospital Universitario Alvaro Cunqueiro
  • Vizcaya
    • Baracaldo, Vizcaya, Spain, 48903
      • Hospital Universitario de Cruces
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital Universitario de Basurto
  • Álava
    • Vitoria-Gasteiz, Álava, Spain, 01009
      • Hospital Universitario de Araba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The event rate will be calculated for:	Cardiovascular deaths	24 months
The event rate will be calculated for:	Non-cardiovascular deaths	24 months
The event rate will be calculated for:	Myocardial infarctions (MI: QMI and NQMI, TV, NTV)	24 months
The event rate will be calculated for:	Revascularization of the treated lesions induced by ischemia (ID-TLR)	24 months
The event rate will be calculated for:	Revascularization of the treated vessels induced by ischemia (ID-TVR)	24 months
The event rate will be calculated for:	All revascularizations (PCI vs. CABG)	24 months
The event rate will be calculated for:	Thrombosis of the device. Classification (acute, sub-acute, delayed) and evidence classification (definitive, probable, possible)	24 months
The event rate will be calculated for:	Overlapping devices and features	24 months
The event rate will be calculated for:	The immediate success of the device	24 months
The event rate will be calculated for:	The immediate success if the procedure	24 months
The event rate will be calculated for:	The failure of the lesion treated through a combined rate of cardiac death, TV-IM and ID-TLR: (Failure of treated lesion (TLF))	24 months
The event rate will be calculated for:	The failure of the vessel treated through a combined rate of cardiac death, total myocardial infarction and ID-TVR: (Failure of treated vessel (TVF))	24 months
The rate of:	Overlapping stents will be calculated in relation to those implanted, and the relation with the appearance of clinical events.	24 months
The rate of:	Image parameters will be calculated in the cases in which, in the opinion of the researcher, coronary function or intravascular imaging tests have been performed (FFR, IVUS, OCT).	24 months

Collaborators and Investigators

• Sponsor: Spanish Society of Cardiology
• Investigators: Study Director: Andres I Romo, MD, PhD, Spanish Society of Cardiology

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 26, 2017
• Primary Completion (ACTUAL): June 7, 2021
• Study Completion (ACTUAL): June 7, 2021

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (ACTUAL): January 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Magmaris
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: MAGMARIS-ES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No