- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03125772
Trial on Safety & Performance of TAXUS Element vs. XIENCE Prime Stent in Treatment of Coronary Lesion in Diabetics (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
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.
Study Overview
Status
Conditions
Detailed Description
Primary Endpoint:
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)
Secondary Endpoint:
Clinical endpoints measured at 30, 180 days, and 1 and 2 years post index procedure:
- TVF rate (primary endpoint 1 year)
- Target Vessel Revascularization (TVR) rate
- Target Lesion Revascularization (TLR)
- Composite of cardiac death or target vessel MI
- Composite of all deaths, all MI, all revascularizations
- Major Adverse Cardiac Events (MACE) which is the composite endpoint of cardiac death, all myocardial infarction, and TLR
- MI (Q-wave and non-Q-wave) rate
- Cardiac death rate
- Non-cardiac death rate
- All death rate
- Cardiac death or MI rate
- All death or MI rate
- Stent thrombosis rate (definite or probable by Academic Research Consortium [ARC] definitions)
Periprocedural endpoints:
- Technical success rate
- Clinical procedural success rate
Anti-platelet Therapy
A loading dose of either Clopidogrel (300mg, 600mg recommended), Ticlopidine (500mg), or Prasugrel (60mg) must be given to the patient prior to index procedure. Thereafter, Clopidogrel (75mg daily), Ticlopidine (250mg twice daily), Prasugrel (10mg) must be given for at least 12 months after stent implantation. If the protocol mandated (loading and or daily) dosage conflicts with local DFU, the local DFU should take precedence. Aspirin (ASA): Must be administered concomitantly with Clopidogrel, Ticlopidine or Prasugrel and then continued indefinitely
Sample Size Parameters:
The expected 12 month TVF rate for both groups is estimated to be 8.4% based on the data available from the SPIRIT IV trial. Given the non-inferiority margin (delta) of 4% with equal expected means and a one-sided 5% significance level, 824 patients in each group will provide at least 90% power to reject the null hypothesis if it is false. When allowance is made for 10% attrition, approximately 915 patients are required per each treatment group. Therefore, the necessary total sample size for the trial is 1,830 patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110025
- Fortis Escorts Heart Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
CI1. Patient must have a diagnosis of diabetes mellitus (Type 1 or Type 2) defined according to the American Diabetes Association as history of one of the followings :
- Two hour plasma glucose >200 mg/dL (11.1 mmol/L) following a 75g oral glucose tolerance test
- Random plasma glucose >200 mg/dL 3. A fasting plasma glucose level >126 mg/dL (7.0 mmol/L)
4. Elevated HbA1c level 6.5 And currently undergoing pharmacological treatment 5.Patients admitted with ACS NSTEMI and HbA1c > 7 can be included even if they were not on pharmacological treatment. CI2. Patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed CI3. Patient is eligible for percutaneous coronary intervention (PCI) CI4. Patient has symptomatic coronary artery disease or documented silent ischemia. CI5. Patient is willing to comply with all protocol-required follow-up evaluations.
Angiographic Inclusion Criteria (visual estimate)
AI1. Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) 2.25 mm and 4.0 mm. Treatment of up to 3 de novo target lesions is allowed with a maximum of two denovo target lesions per epicardial vessel.
AI2. Target lesion length must measure 34 mm (by visual estimate) AI3. Target lesion must be in a major coronary artery or branch with visually estimated stenosis 50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow 1. AI4. If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria. AI5. Non-study percutaneous intervention for lesions in a target vessel (including side branches) is allowed if performed 9 months prior to the index procedure. AI6. Non study percutaneous interventions for lesions in a non target vessel are allowed in the following circumstances:
- Unsuccessful, or complicated bare metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if performed 30 days prior to the index procedure.
- Drug-eluting stent treatment is permitted if performed 90 days prior to index procedure. AI7. Non study, percutaneous interventions for lesion(s) in a target vessel (including side branches) or non-target vessel are allowed if performed 9 months after the index procedure.
Exclusion Criteria:
CE1. Patient has known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, iron, thienopyridines, aspirin, radiographic contrast medium) that cannot be adequately pre-medicated. CE2. Patient has any other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months CE3. Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or 177 μmol/l) CE4. Currently participating in another investigational drug or device study
Angiographic Exclusion Criteria (visual estimate)
AE1. Target lesion meets any of the following criteria:
- Left main location including left main ostial location
- Located within 2 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate
- Located within a saphenous vein graft or an arterial graft or distal to a diseased arterial or saphenous vein graft. Diseased graft defined as irregularity per angiogram and any visually estimated diameter stenosis > 20%.
- Involves a bifurcation in which the side branch 2.0 mm in diameter AND the ostium of the side branch is > 50% stenosed by visual estimate.
- Involves a side branch requiring pre-dilatation
- TIMI flow 0 (total occlusion) prior to guide wire crossing
- Excessive tortuosity proximal to or within the lesion
- Extreme angulation ( ≥90°) proximal to or within the lesion
- Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
- Restenotic from previous intervention
- Thrombus, or possible thrombus, present in the target vessel AE2. Patient has an additional clinically significant lesion(s) in the target vessel for which an intervention within 9 months after the index procedure may be required
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TAXUS Element™ Paclitaxel-Eluting System
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.
|
Texus Element is the next generation Boston Scientific paclitexel-eluting coronary sten and received DCGI approval on April 13th, 2010.
|
Active Comparator: XIENCE PRIME™ ™ Everolimus-Eluting Stent System
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.
|
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA, as Xience Prime.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: 12 Months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target Lesion Revascularization (TLR) TVF rate (primary endpoint 1 year) Target Vessel Revascularization rate Target Lesion Revascularization Composite of cardiac death or target vessel
Time Frame: Measured at 30,180 days,and 1 and 2 years post index procedure
|
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
Time Frame: Measured at 30,180 days,and 1 and 2 years post index procedure
|
Measured at 30,180 days,and 1 and 2 years post index procedure
|
|
Target Vessel Failure (TVF)
Time Frame: Measured at 30,180 days,and 1 and 2 years post index procedure
|
Measured at 30,180 days,and 1 and 2 years post index procedure
|
|
Ischemia Driven Target Vessel Revascularization (TVR)
Time Frame: Measured at 30,180 days,and 1 and 2 years post index procedure
|
Measured at 30,180 days,and 1 and 2 years post index procedure
|
|
Target Lesion Failure Rate
Time Frame: Measured at 30,180 days,and 1 and 2 years post index procedure
|
Target Lesion Failure Rate defined as any ischemia-driven revascularization of the target lesion (TLR), MI (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel
|
Measured at 30,180 days,and 1 and 2 years post index procedure
|
Myocardial Infarction(MI) rate
Time Frame: Measured at 30,180 days,and 1 and 2 years post index procedure
|
Q-wave and Non-Q-wave, cumulative and individual
|
Measured at 30,180 days,and 1 and 2 years post index procedure
|
Cardiac death rate
Time Frame: Measured at 30,180 days,and 1 and 2 years post index procedure
|
Measured at 30,180 days,and 1 and 2 years post index procedure
|
|
Non-Cardiac death rate
Time Frame: Measured at 30,180 days,and 1 and 2 years post index procedure
|
Measured at 30,180 days,and 1 and 2 years post index procedure
|
|
All death or MI rate
Time Frame: Measured at 30,180 days,and 1 and 2 years post index procedure
|
Measured at 30,180 days,and 1 and 2 years post index procedure
|
|
All Death / MI / TVR Rate
Time Frame: Measured at 30,180 days,and 1 and 2 years post index procedure
|
Measured at 30,180 days,and 1 and 2 years post index procedure
|
|
Major Adverse Cardiac Event (MACE)
Time Frame: Measured at 30,180 days,and 1 and 2 years post index procedure
|
MACE defined as a composite of death, MI (Q-wave and non-Q-wave), emergent coronary artery bypass surgery (CABG), or target lesion revascularization (TLR) by repeat PTCA, or CABG.
|
Measured at 30,180 days,and 1 and 2 years post index procedure
|
Stent Thrombosis Rate
Time Frame: Measured at 30,180 days,and 1 and 2 years post index procedure
|
Stent thrombosis(ST) rate defined using ARC definition of definite and probable stent thrombosis and categorized as early, late or very late.
|
Measured at 30,180 days,and 1 and 2 years post index procedure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device Success
Time Frame: Baseline
|
Device Success Defined as attainment of <30% residual stenosis of the target lesion (visual assessment) using the TAXUS Element or XIENCE Prime stent.
|
Baseline
|
Lesion Success
Time Frame: Baseline
|
Lesion success defined as attainment of <30% residual stenosis (visual assessment) uring any percutaneous method
|
Baseline
|
Procedure Success
Time Frame: Baseline
|
Procedure success defined as lesion success without the occurrence of in-hospital MACE.
|
Baseline
|
Procedural complication rate
Time Frame: Baseline
|
Procedural complication rate including composite and individual angiographic occurrence of dissection, distal embolization, no reflow, slow flow, abrupt closure, or perforation
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Upendra Kaul, M.D, Fortis Escorts Heart Institute
Publications and helpful links
General Publications
- www.crf.org/crf/newsroom/news/news-archive/963-announcing-the-tct-2015-late-breaking-trials-and-first-report-investigations
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Everolimus
Other Study ID Numbers
- Tuxedo
- CTRI/2011/06/001830 (Registry Identifier: Clinical Trial Registry - India)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Not yet recruitingType 2 Diabetes Mellitus
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
University of Alabama at BirminghamCompletedType 2 Diabetes MellitusUnited States
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted
Clinical Trials on TAXUS Element™ Paclitaxel-Eluting Stent System
-
Centre Chirurgical Marie LannelongueCentre Hospitalier Universitaire de Nice; University Hospital, Limoges; Hôpital... and other collaboratorsCompletedDiabetes | Coronary Heart Disease | Chronic Total Occlusion of Coronary Artery | Restenosis | Vascular LesionsFrance
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary RestenosisNetherlands, Spain, Denmark, Germany, France, Austria, Belgium, India, Italy, New Zealand, Poland, South Africa, Switzerland
-
Abbott Medical DevicesCompletedCoronary Artery DiseaseUnited States
-
Abbott Medical DevicesCompletedMyocardial Ischemia | Coronary Artery Disease | Stent Thrombosis | Vascular Disease | Coronary Artery Stenosis | Stents | Total Coronary Occlusion | Coronary Artery RestenosisUnited States
-
National University Hospital, SingaporeBoston Scientific CorporationUnknown
-
Boston Scientific CorporationCompletedCoronary Artery DiseaseUnited States, Australia, New Zealand, Singapore
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary RestenosisNew Zealand, Australia, Germany, France, Switzerland, Netherlands, United Kingdom, Portugal, Belgium, Denmark
-
Cordis CorporationConor MedsystemsCompletedCoronary DiseaseUnited States
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary RestenosisUnited States, Australia, New Zealand, Germany
-
Cordis CorporationConor MedsystemsTerminatedCoronary AtherosclerosisBrazil, New Zealand