NCT03413813

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 262 (actual)
• Sponsor: Spanish Society of Cardiology · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Magmaris	Severe stenosis de novo, in native coronary arteries, treated with percutaneous coronary intervention with scaffold implantation.

Timeline

• Start date: 2017-07-26
• Primary completion: 2021-06-07
• Completion: 2021-06-07
• First posted: 2018-01-29
• Last updated: 2021-07-15

Locations

31 sites across 1 country: Spain