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

Coronary Artery Disease Clinical Trial

— MAGMARIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413813
• Other study ID #: MAGMARIS-ES
• Status: Completed
• Start date: July 26, 2017
• Est. completion date: June 7, 2021

Study information

• Verified date: July 2021
• Source: Spanish Society of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: June 7, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Hospital Universitario de Cruces	Baracaldo	Vizcaya
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Clinic de Barcelona	Barcelona
Spain	Hospital Universitario Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario Vall d´Hebron	Barcelona
Spain	Hospital Universitario de Basurto	Bilbao	Vizcaya
Spain	Hospital Universitario San Pedro de Alcántara	Cáceres
Spain	Hospital Universitario Puerta del Mar	Cádiz
Spain	Hospital Universitario Santa Lucía	Cartagena	Murcia
Spain	Hospital Universitario General de Castellón	Castellón De La Plana	Castellón
Spain	Hospital Universitario General de Ciudad Real	Ciudad Real
Spain	Hospital Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Universitario Doctor Josep Trueta	Gerona
Spain	Hospital San Cecilio-Campus de la Salud	Granada
Spain	Hospital Universitario de Bellvitge	L'Hospitalet De Llobregat	Barcelona
Spain	Hospital Universitario Arnau de Vilanova	Lleida
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Islas Baleares
Spain	Hospital Universitario Puerto Real	Puerto Real	Cádiz
Spain	Hospital Universitario de Santiago de Compostela	Santiago De Compostela	A Coruña
Spain	Hospital Universitario Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital Universitario Clínico de Valencia	Valencia
Spain	Hospital Universitario General de Valencia	Valencia
Spain	Hospital Universitario Álvaro Cunqueiro	Vigo	Pontevedra
Spain	Hospital Universitario de Áraba	Vitoria-Gasteiz	Álava
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Society of Cardiology

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A combined rate (incidence of events) of:	The cardiac death (incidence of events).	12 months
Primary	A combined rate (incidence of events) of:	Myocardial infarction (incidence of events)	12 months
Primary	A combined rate (incidence of events) of:	Revascularization of the treated lesion (TLR) induced by ischemia (incidence of events)	12 months
Secondary	The event rate will be calculated for:	Cardiovascular deaths	24 months
Secondary	The event rate will be calculated for:	Non-cardiovascular deaths	24 months
Secondary	The event rate will be calculated for:	Myocardial infarctions (MI: QMI and NQMI, TV, NTV)	24 months
Secondary	The event rate will be calculated for:	Revascularization of the treated lesions induced by ischemia (ID-TLR)	24 months
Secondary	The event rate will be calculated for:	Revascularization of the treated vessels induced by ischemia (ID-TVR)	24 months
Secondary	The event rate will be calculated for:	All revascularizations (PCI vs. CABG)	24 months
Secondary	The event rate will be calculated for:	Thrombosis of the device. Classification (acute, sub-acute, delayed) and evidence classification (definitive, probable, possible)	24 months
Secondary	The event rate will be calculated for:	Overlapping devices and features	24 months
Secondary	The event rate will be calculated for:	The immediate success of the device	24 months
Secondary	The event rate will be calculated for:	The immediate success if the procedure	24 months
Secondary	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
Secondary	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
Secondary	The rate of:	Overlapping stents will be calculated in relation to those implanted, and the relation with the appearance of clinical events.	24 months
Secondary	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