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

This is an interventional treatment trial for Type 2 Diabetes focused on measuring coronary artery disease, diabetes mellitus, everolimus, paclitaxel stents Read More

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 :

1. Two hour plasma glucose >200 mg/dL (11.1 mmol/L) following a 75g oral glucose tolerance test
2. 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:

1. 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.
2. 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