Sahajanand Medical Technologies (SMT) announced the completion of patient enrolment for the Tuxedo 2 clinical trial in India. This trial aims to evaluate the efficacy and safety of Supraflex Cruz Drug-Eluting Stent (DES) in diabetic patients with multivessel coronary artery disease (CAD).
The Tuxedo 2 trial is designed to challenge existing paradigms in the treatment of multivessel CAD among diabetic patients, building on the insights from previous studies like the Freedom trial. The trial seeks to address the unique challenges faced by diabetic patients who are at a higher risk of adverse outcomes following percutaneous coronary interventions (PCI).
Tuxedo-2 is a prospective, multicentre, open-label, randomised trial initiated on February 25, 2020. The trial completed enrolment on August 6, 2024, with 1,800 patients across 63 centres in India.
Key highlights:
Focus: The study assesses primary endpoints such as target lesion failure (TLF) at 12 months, major adverse cardiac events (MACE), and stent thrombosis, along with secondary and tertiary objectives related to CABG and antiplatelet therapies (Ticagrelor vs. Prasugrel).
Innovation: Utilising SMT’s latest generation DES technology, the study aims to improve vascular healing and reduce restenosis rates.
The Tuxedo 2 trial aims to provide valuable data that aims to redefine treatment strategies for diabetic patients with complex coronary artery disease.