Drug eluting stent for diabetic patient with heart disease.

Phase 4

Conditions: Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

Registration Number: CTRI/2019/02/017613

Lead Sponsor: Istituto Clinico SantAmbrogio

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1) The patient must be at least 18 years of age;

2) Diabetic patient having clinical evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia or positive functional study; acute coronary syndromes will be considered);

3) The patient is an acceptable candidate for percutaneous trans-luminal coronary angioplasty (PTCA) stenting and emergent coronary artery bypass graft (CABG) surgery;

4) Culprit de novo lesion in a native coronary artery with significant stenosis ( >50% by visual estimate) eligible for stent implantation (no limitation on the number of treated lesions, vessel and lesion length);

5) Patients included are those for whom the physician has already considered worthwhile the use of Abluminus Stent according to the indications provided by the IFU;

6) Patient provides written informed consent;

7) Patient agrees to all required follow-up procedures and visits.

Exclusion Criteria

1) The patient has a known hypersensitivity or contraindication to any of the following medications:Heparin, Aspirin, Both Clopidogrel and TIclopidine, Sirolimus, paclitaxel, ABT 578Stainless steel, Cobalt, biodegradable PLLA polymer;

2) Patients with hypersensitivity to contrast media who cannot be treated with adequate prophylaxis;

3) Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study;

4) Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;

5) History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;

6) Previous coronary intervention on target vessel;

7) Lesions not allowing a complete balloon inflation or stent deployment;

8) Non cardiac related any codition in which life expectancy is less than 1 year or may result in protocol non-compliance.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure that is composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularisation within 12 months.Timepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
1)Stent thrombosis [Time Frame: 1 month, 12 months, yearly]. Definite and probable stent thrombosis according to ARC definitions; <br/ ><br>2) Cardiac death [Time Frame: 1 month, 12 months, yearly]; <br/ ><br>3) Target Vessel Myocardial infarction [Time Frame: 1 month, 12 months, yearly]; <br/ ><br>4) Target Lesion Revascularisation [Time Frame: 1 month, 12 months, yearly]; <br/ ><br>5) Device Success at 24 hours; <br/ ><br>6) Lesion Success at 24 hours; <br/ ><br>7) Procedural Success at 24 hours. <br/ ><br>Timepoint: 1 month, 12 month and yearly.