Status:
COMPLETED
Registry of Patients With a Bioabsorbable Magnesium Stent Implant MAGMARIS in Usual Clinical Practice
Lead Sponsor:
Spanish Society of Cardiology
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-99 years
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 dat...
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 indic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 26 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 7 2021
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT03413813
Start Date
July 26 2017
End Date
June 7 2021
Last Update
July 15 2021
Active Locations (31)
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1
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15706
2
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07120
3
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
4
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221