Tuxedo
A Prospective, Single Blind, Multi-center, Randomized Trial to Compare the TAXUS Element™ Coronary Stent System Against the XIENCE Prime™ Coronary Stent System in the Treatment of a Diabetic Patient PopulatiOn in India
Sponsor study identifier
Secondary identifiers
REGISTRY · Clinical Trial Registry - India
interventional
1,830
1 country
1
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2016
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 2015
Actual (reported)September 2, 2015
Actual (reported)May 2016
Actual (reported)April 24, 2017
Actual (reported)Composite safety endpoint of Target Vessel Failure (TVF) rate at 12 months post-index procedure: • Cardiac Death related to target vessel • Target Vessel Myocardial Infarction (TV-MI) • Target Vessel Revascularization (TVR)
TVS is defined as any ischemia-driven revascularization of the target vessel( TVR), MI (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
12 Months
Target Lesion Revascularization (TLR) TVF rate (primary endpoint 1 year) Target Vessel Revascularization rate Target Lesion Revascularization Composite of cardiac death or target vessel
Measured at 30,180 days,and 1 and 2 years post index procedure
Ischemia Driven Target Lesion Revascularization (TLR) Rate TVF rate (primary endpoint 1 year) Target Vessel Revascularization rate Target Lesion Revascularization Composite of cardiac death or target vessel
Measured at 30,180 days,and 1 and 2 years post index procedure
Target Vessel Failure (TVF)
Measured at 30,180 days,and 1 and 2 years post index procedure
Ischemia Driven Target Vessel Revascularization (TVR)
Measured at 30,180 days,and 1 and 2 years post index procedure
Target Lesion Failure Rate
Measured at 30,180 days,and 1 and 2 years post index procedure
Device Success
Baseline
Lesion Success
Baseline
Procedure Success
Baseline
The TAXUS® Element™ stent system is a multifunctional device providing a mechanical structure for vascular lumen support and a pharmacological agent targeted toward reducing or preventing the incidence of restenosis. The TAXUS Element™ stent is a balloon expandable, stainless steel platinum alloy stent, coated with paclitaxel in a slow-release system, pre-mounted on a high-pressure Monorail delivery catheter and is intended for use in the treatment of coronary artery disease. The pharmacological agent, paclitaxel, is incorporated into a triblock polymer matrix and applied to the surface of the stent. The polymer matrix provides controlled release of available paclitaxel. The TAXUS Element™ stent design is built upon the TAXUS Express and TAXUS Liberte design experience, but incorporates several improved stent design characteristics. The TAXUS Element™ stent also has a smaller tip profile, designed to enhance the ability to cross tighter and/or more complex lesions.
The everolimus-eluting stent (EES, manufactured and distributed by Abbott Vascular, Santa Clara, CA, as XIENCE PRIME™ ) is a balloon expandable stent manufactured from a flexible cobalt chromium alloy with a multicellular design and 0.0032-in strut thickness which is coated with a thin (7.8 μm) nonadhesive, durable, biocompatible acrylic polymer and fluorinated copolymer releasing everolimus. Everolimus \[40-O-(2-hydroxyethyl)- rapamycin\], a semisynthetic macrolide immunosuppressant, inhibits growth factor-stimulated cell proliferation by causing cell-cycle arrest in the late G1 stage, thereby suppressing neointimal formation. Comparative analysis in an in vivo rabbit aortoiliac model has shown more rapid endothelialization with the EES compared to SES, PES, and ZES.
Texus Element is the next generation Boston Scientific paclitexel-eluting coronary sten and received DCGI approval on April 13th, 2010.
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA, as Xience Prime.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Device product
TAXUS Element™ Paclitaxel-Eluting Stent System
The registry describes a device or delivery product. Its exact ingredients and actual exposure require separate evidence.
View registry recordDevice product
Xience PRIME Everolimus-Eluting Stent System
The registry describes a device or delivery product. Its exact ingredients and actual exposure require separate evidence.
View registry recordFortis Escorts Heart Institute
New Delhi, National Capital Territory of Delhi, 110025, India
www.crf.org/crf/newsroom/news/news-archive/963-announcing-the-tct-2015-late-breaking-trials-and-first-report-investigations
Upendra Kaul, M.D
Fortis Escorts Heart Institute
1,830 participants (actual enrollment reported by the registry).
First Submitted
September 2, 2015
First Posted
April 24, 2017
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2016
Actual (reported)Last Updated
April 24, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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