Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population (PARTICIPATE)

CID Carbostent & Implantable Devices

Status

Completed

Conditions

Unstable Angina

Stable Angina

Acute Myocardial Infarction

Treatments

Device: Amphilimus Eluting Stent (CRE8)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01556126

C21102

Details and patient eligibility

About

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.

Enrollment

1,191 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;
Patient underwent target vessel revascularization with a DES within 3 months prior to the index procedure;
Target lesion is located or supplied by an arterial or venous bypass graft.