Second-generation Drug-eluting Stents in Diabetes

Phase 4

• Conditions: Diabetes Mellitus; Coronary Artery Disease
• Interventions: Device: Polymer-free amphilimus-eluting stents; Device: Biolinx Polymer-based zotarolimus-eluting stents

• Registration Number: NCT03321032
• Lead Sponsor: Spanish Society of Cardiology

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 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-22
• Study First Submitted QC: 2017-10-22
• Study First Posted: 2017-10-25
• Study Start: 2017-12-19
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19
• Primary Completion: 2021-01-28
• Study Completion: 2022-01-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1164

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amphilimus-eluting stents	Polymer-free amphilimus-eluting stents	Polymer-free Amphilimus-eluting stents
Zotarolimus-eluting stents	Biolinx Polymer-based zotarolimus-eluting stents	Biolinx Polymer-based zotarolimus-eluting stents

Primary Outcome Measures

Name	Time	Method
Target lesion failure at 1-year follow-up	12 months	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.
Target lesion failure at 2-years follow-up	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Target vessel myocardial infarction	12 and 24 months
Stent thrombosis	12 and 24 months	Academic Research Consortium definitions
Cardiac death	12 and 24 months
Non-target lesion revascularization	12 and 24 months
Target vessel revascularization	12 and 24 months
Target lesion revascularization	12 and 24 months

Trial Locations

Locations (23)

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario de León; 🇪🇸 León, Spain

Hospital Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital de Santiago; 🇪🇸 Santiago De Compostela, Spain

Hospital Universitario Son Espases; 🇪🇸 Palma De Mallorca, Spain

Hospital San Juan; 🇪🇸 Alicante, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Spain

Clínica Universidad de Navarra; 🇪🇸 Madrid, Spain

Hospital Joan XXIII; 🇪🇸 Tarragona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Juan Ramón Jiménez; 🇪🇸 Huelva, Spain

Hospital Doctor Negrín; 🇪🇸 Las Palmas De Gran Canaria, Spain

Hospital Lucus Augusti; 🇪🇸 Lugo, Spain

Hospital Universitario de Canarias; 🇪🇸 Tenerife, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Clínico de Valencia; 🇪🇸 Valencia, Spain

Hospital Vall d'Hebrón; 🇪🇸 Barcelona, Spain