DRUG ELUTING STENT FOR DIABETIC PATIENTS IN CORONARY ARTERY DISEASE TREATMENT

Summary

Study Title A post market registry of Abluminus® sirolimus eluting coronary stent system for percutaneous intervention in patients with diabetes mellitus Purpose The purpose of this registry is to prospectively capture clinical data of ABLUMINUS® sirolimus eluting stent in patients with Diabetes Mellitus.

Investigational Device ABLUMINUS® sirolimus eluting stent consists of four components; a bare metal stent (BMS), a delivery system, the bio absorbable polymer delivery matrix and Abluminal surface coating on stent and parts of balloon in Pre-crimped condition the anti-proliferative drug, Sirolimus.

Study Design Prospective, Observational, Multi-center registry Estimated Enrolment 1000 patients

End points Primary Endpoints:

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

Components of the primary end point are defined as follows:

* Cardiac Death: any death due to immediate cardiac cause, deaths related to the procedure, unwitnessed death, and death of unknown cause.
* Target Vessel Myocardial infarction: categorised according to the Minnesota electrocardiographic criteria (Q-wave and non-Q-wave). Spontaneous myocardial infarction was defined as a typical rise and fall of creatinine kinase-MB fraction or troponin in the presence of at least one of several conditions: ischaemic symptoms, new pathological Q waves, ischaemic electrocardiographic changes, or pathological evidence of acute myocardial infarction. Peri-procedural myocardial infarction was defined as an increase in creatinine kinase to more than twice the normal value with increased values of confirmatory biomarkers (creatinine kinase-MB fraction or troponin higher than usual). Target-vessel-related myocardial infarction was one related to the target vessel or that could not be clearly related to another vessel.
* Target Lesion Revascularisation: any repeat percutaneous or surgical intervention due to a stenosis or occlusion within the device of the index procedure.

Secondary Endpoints

* Stent thrombosis \[Time Frame: 1 month, 12 months, yearly\]. Definite and probable stent thrombosis according to ARC definitions;
* Cardiac death \[Time Frame: 1 month, 12 months, yearly\]
* Target Vessel Myocardial infarction \[Time Frame: 1 month, 12 months, yearly\]
* Target Lesion Revascularisation \[Time Frame: 1 month, 12 months, yearly\]
* Device Success at 24 hours
* Lesion Success at 24 hours
* Procedural Success at 24 hours Eligibility Eligible Age: 18 Years and older. Eligible Genders: Both. Inclusion Criteria
* The patient must be at least 18 years of age.
* 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).
* The patient is an acceptable candidate for percutaneous trans-luminal coronary angioplasty (PTCA) stenting and emergent coronary artery bypass graft (CABG) surgery.
* 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);
* 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;
* Patient provides written informed consent;
* Patient agrees to all required follow-up procedures and visits. Exclusion Criteria • 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.
* Patients with hypersensitivity to contrast media who cannot be treated with adequate prophylaxis.
* Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study.
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
* Previous coronary intervention on target vessel.
* Non-cardiac co-morbid conditions with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
* Lesions not allowing a complete balloon inflation or stent deployment. Clinical Follow up At Discharge, 1 month, 6 months, 12 months, yearly.

Conditions

• Coronary Artery Disease

Interventions

DEVICE

PCI

PCI

Sponsors & Collaborators

• IRCCS Policlinico S. Donato

  collaborator OTHER

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2019-01-31

Completion

2022-01-31

Countries

• Italy

Study Locations