Registry of Patients With a Bioabsorbable Magnesium Stent Implant MAGMARIS in Usual Clinical Practice
Sponsored by Spanish Society of Cardiology
About this trial
Last updated 4 years ago
Study ID
MAGMARIS-ES
Status
Completed
Type
Observational [Patient Registry]
Placebo
No
Accepting
18 to 99 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 4 years ago
What is this trial about?
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.
What are the participation requirements?
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.