Clinical trial NCT03413813: Registry of Patients With a Bioabsorbable Magnesium Stent Implant MAGMARIS in Usual Clinical Practice
Official title: Prospective Observational Registry of Patients With a Bioabsorbable Magnesium Stent Implant -MAGMARIS- in Usual Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Magmaris
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: A combined rate (incidence of events) of:
timeFrame: 12 months
measure: A combined rate (incidence of events) of:
timeFrame: 12 months
measure: A combined rate (incidence of events) of:
timeFrame: 12 months
Secondary outcomes:
measure: The event rate will be calculated for:
timeFrame: 24 months
measure: The event rate will be calculated for:
timeFrame: 24 months
measure: The event rate will be calculated for:
timeFrame: 24 months
measure: The event rate will be calculated for:
timeFrame: 24 months
measure: The event rate will be calculated for:
timeFrame: 24 months
measure: The event rate will be calculated for:
timeFrame: 24 months
measure: The event rate will be calculated for:
timeFrame: 24 months
measure: The event rate will be calculated for:
timeFrame: 24 months
measure: The event rate will be calculated for:
timeFrame: 24 months
measure: The event rate will be calculated for:
timeFrame: 24 months
measure: The event rate will be calculated for:
timeFrame: 24 months
measure: The event rate will be calculated for:
timeFrame: 24 months
measure: The rate of:
timeFrame: 24 months
measure: The rate of:
timeFrame: 24 months
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Universitario de Santiago de Compostela
state: A Coruña
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua de Terrassa
state: Barcelona
city: Castellón De La Plana
country: Spain
facility: Hospital Universitario General de Castellón
state: Castellón
city: Puerto Real
country: Spain
facility: Hospital Universitario Puerto Real
state: Cádiz
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Cartagena
country: Spain
facility: Hospital Universitario Santa Lucía
state: Murcia
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
state: Murcia
city: Vigo
country: Spain
facility: Hospital Universitario Álvaro Cunqueiro
state: Pontevedra
city: Baracaldo
country: Spain
facility: Hospital Universitario de Cruces
state: Vizcaya
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
state: Vizcaya
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´Hebron
city: Barcelona
country: Spain
facility: Hospital Universitario Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Santa Creu i Sant Pau
city: Ciudad Real
country: Spain
facility: Hospital Universitario General de Ciudad Real
city: Cáceres
country: Spain
facility: Hospital Universitario San Pedro de Alcántara
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Gerona
country: Spain
facility: Hospital Universitario Doctor Josep Trueta
city: Granada
country: Spain
facility: Hospital San Cecilio-Campus de la Salud
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Valencia
country: Spain
facility: Hospital Universitario Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario General de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario de Áraba
state: Álava
Study officials:
affiliation: Spanish Society of Cardiology
name: Andres I Romo, MD, PhD
role: STUDY_DIRECTOR
References: