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

NCT03125772 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1830

Last updated 2017-04-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

TAXUS Element™ Paclitaxel-Eluting Stent System

Texus Element is the next generation Boston Scientific paclitexel-eluting coronary sten and received DCGI approval on April 13th, 2010.

DEVICE

Xience PRIME Everolimus-Eluting Stent System

The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA, as Xience Prime.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Max Neeman Medical International Ltd.

    collaborator UNKNOWN

  • Fortis Escorts Heart Institute

    lead OTHER

Principal Investigators

  • Upendra Kaul, M.D · Fortis Escorts Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-05-31
Completion
2016-05-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03125772 on ClinicalTrials.gov