This is an investigator initiated study to compare the safety and performance of the TUXEDO and XIENCE Prime stent system in the treatment of Coronary lesion in Diabetic Mellitus patient population in India.

Phase 4

• Conditions: Health Condition 1: null- Coronary Artery Disease, Diabetic Mellitus (Type I & II)

• Registration Number: CTRI/2011/06/001830
• Lead Sponsor: Fortis Escorts Heart institute and Research centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 1830

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 more than 200 mg/dL (11.1 mmol/L) following a 75g oral glucose tolerance test

2.Random plasma glucose more than 200 mg/dL

3. A fasting plasma glucose level more than 126 mg/dL (7.0 mmol/L)

4. Elevated HbA1c level more than or equal to 6.5

And

currently undergoing pharmacological treatment

5. Patients admitted with ACS NSTEMI and HbA1c more than 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 evaluation

AI1. Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) more than or equal to 2.25 mm and less than 4.0 mm. Treatment of up to 3 de novo target lesions is allowed with a maximum of two de novo target lesions per epicardial vessel.

AI2. Target lesion length must measure less than 34 mm (by visual estimate)

AI3. Target lesion must be in a major coronary artery or branch with visually estimated stenosis more than or equal to 50% and less than 100% with Thrombolysis in Myocardial Infarction (TIMI) flow less than 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 more than or equal to 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:

a. Unsuccessful, or complicated bare metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if performed more than or equal to 30 days prior to the index procedure.

b. Drug-eluting stent treatment is permitted if performed more than or equal to 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 more than 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)

CE 4. Currently participating in another investigational drug or device study

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 (≥90o) 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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Vessel Failure - <br/ ><br>Cardiac Death related to target vessel,Target Vessel Myocardial Infarction,Target Vessel Revascularization (TVR) <br/ ><br>Timepoint: 12 months