Prove ART (Abluminal Reservoir Technology) Clinical Benefit in Alla Comers Patients

CID - Carbostent & Implantable Devices23 sites in 6 countries1,191 target enrollmentFebruary 2012

ConditionsStable Angina Unstable Angina Acute Myocardial Infarction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stable Angina
Sponsor: CID - Carbostent & Implantable Devices
Enrollment: 1191
Locations: 23
Primary Endpoint: Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to evaluate safety and efficacy performances of CRE8 Drug Eluting Stent, in patients comparable to the everyday's clinical practice population, with a specific focus on diabetics, that will be part of a pre-specified study subgroup.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

December 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CID - Carbostent & Implantable Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years;
•Patients with symptoms of stable angina or documented silent ischemia;
•Patient with coronary artery disease ranging between 0 and 22 according to the Syntax score;
•Patients with acute coronary syndrome, including unstable angina, NSTEMI and STEMI;
•Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
•Left ventricular ejection fraction \> 30%;
•Target de-novo lesions with diameter stenosis \> 50% (including total occlusion);
•Target lesion located in a target vessel with a diameter ranging from 2.5 to 4.0 mm;
•Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.

Exclusion Criteria

•Female with childbearing potential or lactating;
•Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium;
•Acute or chronic renal dysfunction (defined as creatinine greater than 2.5 mg/dl or on dialysis);
•Thrombocytopenia (platelet count less than 100,000/mm³) or hypercoagulable disorder;
•Known significant gastro-intestinal or urinary bleeding within the past 6 months;
•Patient refusing blood transfusion;
•Patient currently under immunosuppressant therapy;
•Patient with planned surgery within 6 months from the index procedure unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
•Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
•Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;

Outcomes

Primary Outcomes

Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR

Time Frame: 6 months

Secondary Outcomes

Angiographic in-stent and in-segment endpoints (in the first 100 patients included in the pre-specified diabetic subgroup).(At 6 months)
Clinical composite endpoints: - Cardiac death/Target vessel MI/Clinically indicated TLR - All death/All MI/All Repeat Revascularization(At 30 days, 1 year and yearly up to 5 years)
Stent thrombosis(within 24 hours, 1 month, 6 months, 1 year and yearly up to 5 years)