Status:
UNKNOWN
Second-generation Drug-eluting Stents in Diabetes
Lead Sponsor:
Spanish Society of Cardiology
Conditions:
Coronary Artery Disease
Diabetes Mellitus
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
This is an investigator initiated randomized trial, performed under the auspices of the Spanish Society of Cardiology. It is a multicenter, international, parallel, randomized 1:1 (amphilimus-eluting...
Eligibility Criteria
Inclusion
- Inclusion Criteria(must meet all):
- Patients ≥18 years who understands the nature of the study and provides written informed consent.
- Diagnosis of diabetes according to the American Diabetes Association diagnostic criteria (\*)
- Documented silent ischemia, stable angina, unstable angina, or myocardial infarction (with or without ST elevation).
- At least one de novo coronary lesion with stenosis of more than 50% in a vessel with a reference vessel diameter of 2.25 to 4.5 mm by visual estimation. Coronary anatomy is suitable for PCI (patients with potential CABG indication should be eligible for PCI after a multidisciplinary evaluation in a Heart Team).
- Exclusion Criteria:
- Cardiogenic shock or resuscitation
- Comorbidity with anticipated life expectancy to 24 months
- Inability to consent due to mechanical ventilation
- Pregnant female patient
- Conditions that could preclude a minimal of 1 month of DAPT (such as, but not limited to: severe liver failure, platelet count \<100,000 cells/mm3, recent gastrointestinal bleeding or history of bleeding diathesis or coagulopathy)
- Contraindication or known allergy to aspirin, heparin, P2Y12 inhibitors, cobalt and/or chromium metal alloys, sirolimus or derivates, polyurethane, or contrast media (for contrast-media allergy, patients that might be safely and adequately pre-medicated should be allowed to enter the study).
- Currently enrolled in another clinical trial.
Exclusion
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 28 2022
Estimated Enrollment :
1164 Patients enrolled
Trial Details
Trial ID
NCT03321032
Start Date
December 19 2017
End Date
January 28 2022
Last Update
January 19 2021
Active Locations (23)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
2
Hospital General Universitario de Alicante
Alicante, Spain
3
Hospital San Juan
Alicante, Spain
4
Hospital Clinic de Barcelona
Barcelona, Spain