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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03321032
Other study ID # SEC-SUG-2016-01
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date December 19, 2017
Est. completion date January 28, 2022

Study information

Verified date January 2021
Source Spanish Society of Cardiology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 stents vs zotarolimus-eluting stents) clinical trial performed exclusively in patients with diabetes mellitus. The study has an "all-comers diabetics" design. The primary-endpoint is target lesion failure at 1-year follow-up (non-inferiority design) and the co-primary end-point is target lesion failure at 2-years follow-up (superiority-design).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1164
Est. completion date January 28, 2022
Est. primary completion date January 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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.

Study Design


Intervention

Device:
Polymer-free amphilimus-eluting stents
Cre8 Evo coronary stent system (CID, Saluggia, Italy)
Biolinx Polymer-based zotarolimus-eluting stents
Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)

Locations

Country Name City State
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital San Juan Alicante
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Vall d'Hebrón Barcelona
Spain Hospital Reina Sofía Córdoba
Spain Hospital Juan Ramón Jiménez Huelva
Spain Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona
Spain Hospital Doctor Negrín Las Palmas De Gran Canaria
Spain Hospital Universitario de León León
Spain Hospital Lucus Augusti Lugo
Spain Clínica Universidad de Navarra Madrid
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Virgen de la Arrixaca Murcia
Spain Hospital Universitario Son Espases Palma De Mallorca
Spain Hospital Marqués de Valdecilla Santander
Spain Hospital de Santiago Santiago De Compostela
Spain Hospital Joan XXIII Tarragona
Spain Hospital Universitario de Canarias Tenerife
Spain Hospital Virgen de la Salud Toledo
Spain Hospital Clínico de Valencia Valencia
Spain Hospital Álvaro Cunqueiro Vigo

Sponsors (1)

Lead Sponsor Collaborator
Spanish Society of Cardiology

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Romaguera R, Salinas P, Brugaletta S, Gomez-Lara J, Díaz JF, Romero MA, García-Blas S, Ocaranza R, Borde P, Jiménez Kockar M, Millan Segovia R, Íñiguez A, Alameda M, Trillo R, Lee DH, Martín P, López-Benito M, Frutos A, Moreu J, Hernández-Hernández F, Gar — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Target lesion failure at 1-year follow-up A composite of cardiac death, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization at 12-months follow-up. 12 months
Primary Target lesion failure at 2-years follow-up A composite of cardiac death, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization at 24-months follow-up. 24 months
Secondary Cardiac death 12 and 24 months
Secondary Target vessel myocardial infarction 12 and 24 months
Secondary Target vessel revascularization 12 and 24 months
Secondary Target lesion revascularization 12 and 24 months
Secondary Stent thrombosis Academic Research Consortium definitions 12 and 24 months
Secondary Non-target lesion revascularization 12 and 24 months
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