A Randomized Trial of Bare Metal Stent (Cronus®) - Cobalt Chromium Versus Stent Coating With Sirolimus (DES)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Scitech Produtos Medicos Ltda
- Enrollment
- 63
- Locations
- 4
- Primary Endpoint
- Lumen Loss
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The objective of this study is to evaluate the security issues and efficacy of coronary stenting Cobalt Chrome covered with sirolimus-eluting Cobalt Chrome platform in patients with coronary artery lesion.
Detailed Description
Patients will be treated in compliance with the eligibility criteria, with stent study of 16-19mm. All patients are clinically followed for 60 months after the procedure and will undergo a control angiography 6 months. Can be treated multiple lesions, measuring between 2.5-3.5mm (by visual estimate). Patients enrolled will be randomized in a 1:2 propose in one of the groups with or without stent coating, respectively. And a randomized clinical trial, prospective study in 5 centers including 60 patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years and ≤75 years;
- •Symptomatic cardiac ischemic disease and/or documented evidence of myocardial ischemia;
- •Types B1 and B2 coronary lesions (according to the ACC/AHA classification modified by Ellis);
- •Target lesion located in a native coronary artery;
- •Target lesion in vessel with diameter ranging from 2.5 to 3.5 mm (by visual estimate) amenable to treatment (coverage) with a 16- 19mm-long stent;
- •Target lesion with \>50% diameter stenosis (by visual estimate);
- •Acceptable candidate to myocardial revascularization surgery (coronary artery bypass graft surgery);
- •The subject has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.
Exclusion Criteria
- •Female patients of childbearing potential;
- •Recent Q-wave myocardial infarction occurred within 48 hours prior to the index procedure. Recent Q-wave or non-Q-wave myocardial infarction with still elevated levels of cardiac markers;
- •Documented left ventricular ejection fraction \<30%;
- •Renal dysfunction (creatinine \> 2.0 mg/dL or 177 µmol/L);
- •Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³.;
- •White blood cell count \<3,000 cells/mm3;
- •Suspected or documented hepatic disease (including laboratorial evidence of hepatitis);
- •Heart transplant receptor;
- •Known hypersensitivity to cobalt-chromium or to medications such as aspirin, clopidogrel bisulfate (Plavix or ISCOVER), ticlopidine (Ticlid) or heparin.
- •Concurrent medical condition with a life expectancy of less than 12 months;
Outcomes
Primary Outcomes
Lumen Loss
Time Frame: 6 months after the procedure
For an accurate assessment of the stent conditions 6 months after implantation, a follow-up catheterization will be performed at the 6-month visit in order to measure the diameter of the artery at the stented site. The objective is the lumen loss in-segment (including the portion in-stent and edges of 5 mm proximal and distal) at 6 months.
Secondary Outcomes
- Adverse Cardiac Events(30 days, 6, 12 and 60 months after the procedure)