A Total Number of 200 Patients Fulfilling the Selection Clinical Trial
Official title:
CRE8 in All Comers Patients
Verified date | June 2016 |
Source | Tel-Aviv Sourasky Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ethics Commission |
Study type | Interventional |
The purpose of the study is to evaluate clinical performances of Cre8 in all comer population in Subjects over 18 years old who are undergoing a clinically indicated coronary angiogram and angioplasty on de-novo lesion located in native coronary arteries
Status | Completed |
Enrollment | 215 |
Est. completion date | August 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Age over 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 and is an acceptable candidate for surgical revascularization - 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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Tel Aviv Sourasky Medical Center | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of 6-month device-oriented clinical composite endpoint, defined as Cardiac death / Target vessel MI / Clinically indicated TLR | 6 months | No | |
Secondary | Incidence of clinical composite endpoints at 30 days, 1 year from the index procedure | 1 year | No |