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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,830
- Locations
- 1
- 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)
Study Overview
Brief 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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •A fasting plasma glucose level >126 mg/dL (7.0 mmol/L)
- •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. CI
- •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 CI
- •Patient is eligible for percutaneous coronary intervention (PCI) CI
- •Patient has symptomatic coronary artery disease or documented silent ischemia. CI
- •Patient is willing to comply with all protocol-required follow-up evaluations.
- •Angiographic Inclusion Criteria (visual estimate)
- •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.
- •Target lesion length must measure 34 mm (by visual estimate) AI
- •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
- •If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria. AI
- •Non-study percutaneous intervention for lesions in a target vessel (including side branches) is allowed if performed 9 months prior to the index procedure. AI
- •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. AI
- •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
- •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. CE
- •Patient has any other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months CE
- •Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or 177 μmol/l) CE
- •Currently participating in another investigational drug or device study
- •Angiographic Exclusion Criteria (visual estimate)
- •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 AE
- •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
Arms & Interventions
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.
Intervention: TAXUS Element™ Paclitaxel-Eluting Stent System (Device)
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.
Intervention: Xience PRIME Everolimus-Eluting Stent System (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Target Vessel Failure (TVF)(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)
- Stent Thrombosis Rate(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)
- Non-Cardiac death rate(Measured at 30,180 days,and 1 and 2 years post index procedure)
- Myocardial Infarction(MI) rate(Measured at 30,180 days,and 1 and 2 years post index procedure)
- 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)
- All Death / MI / TVR Rate(Measured at 30,180 days,and 1 and 2 years post index procedure)
- Major Adverse Cardiac Event (MACE)(Measured at 30,180 days,and 1 and 2 years post index procedure)
- Cardiac death rate(Measured at 30,180 days,and 1 and 2 years post index procedure)
- All death or MI rate(Measured at 30,180 days,and 1 and 2 years post index procedure)
Investigators
Upendra Kaul
Executive Director and Dean Cardiology
Fortis Escorts Heart Institute