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Trial on Safety & Performance of TAXUS Element vs. XIENCE Prime Stent in Treatment of Coronary Lesion in Diabetics

Fortis Escorts Heart Institute · 2011
ClinicalTrials.gov · Datasets · License: Public Domain · 2011
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coronary-artery-diseasecoronary-heart-diseasediabetes-mellitusnatype-2-diabetes
The TUXEDO-India is a prospective, single blind, multi-center randomized clinical trial to assess the TAXUS Element™ in a consecutive population of diabetic patients with coronary artery disease undergoing coronary revascularization. Approximately 1,830 patients with single or multi lesion, multi vessel coronary artery or saphenous vein graft disease ranging in vessels ranging from 2.25 mm to 4.0 mm in diameter by visual estimate will be enrolled in a 1:1 randomization to TAXUS Element™ vs. XIENCE™ Prime in India at up to 50 clinical sites, to demonstrate the safety and effectiveness of TAXUS Element™ in an unrestricted population. Procedural Endpoints: * Device success, defined as attainment of \< 30% residual stenosis of the target lesion (visual assessment) using the TAXUS Element™ or XIENCE™ Prime stent. * Lesion success defined as attainment of \< 30% residual stenosis (visual assessment) using any percutaneous method. * Procedure success defined as lesion success without the occurrence of in-hospital MACE. * Procedure complication rate including composite and individual angiographic occurrence of dissection ≥B, distal embolization, no reflow, slow flow, abrupt closure, or perforation.
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