Comparison of a Contemporary Sirolimus-eluting Stent (ihtDEStiny®) With Another Everolimus-eluting Stent (Xience™), Both With Permanent Polymers, in Patients With Acute Coronary Syndrome and de Novo Coronary Artery Lesions (DestinACSion Study)

Official Summary

To evaluate the efficacy of the two DES (Drug Eluting Stent) used in terms of device-related adverse events at 12 months after PCI (Percutaneous Coronary Intervention). To compare the clinical safety and efficacy by comparing net clinical events (defined as the combination of ischemic and hemorrhagic events) of the two DES used at 12 months after PCI.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 2,100 participants

Interventions

• DEVICE: ihtDEStiny® DES implanted — ihtDEStiny® DES implanted
• DEVICE: Xience™ DES implanted — Xience™ DES implanted

Primary Outcomes

• EFFICACY: Device-oriented Composite Endpoint (DoCE) (12 months)
• NACE (12 months)

Secondary Outcomes

• All-Cause Death Rate at 12 months (12 months)
• All-Cause Death Rate at 24 months (12 months)
• Cardiac Death Rate at 12 months (12 months)
• Cardiac Death Rate at 24 months (12 months)
• Myocardial Infarction Rate at 12 months (12 months)

Trial Locations

• Hospital Universitario San Juan Alicante, Alicante, Spain
• Hospital Universitari Germans Trias I Pujol, Badalona, Spain
• Hospital Universitari Vall d'Hebron, Barcelona, Spain
• Hospital Universitario Virgen de La Arrixaca, El Palmar, Spain
• Hospital Universitario La Paz, Fuencarral-El Pardo, Spain
• Hospital Universitario Juan Ramón Jiménez, Huelva, Spain
• Hospital Universitario de Leon, León, Spain
• Hospital Universitari Arnau de Vilanova, Lleida, Spain
• Hospital Universitario Lucus Agustí, Lugo, Spain
• Hospital Universitario de Canarias, San Cristóbal de La Laguna, Spain
• ...and 2 more locations

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