Coronary Artery Disease
Conditions
Keywords
drug eluting stent
Brief summary
This First In Man study is a prospective, multicentre, single blind, randomized, controlled clinical trial of the CINATRA™ ISA 247 Coated Coronary Stent System as compared to the CINATRA™ Coronary Stent System. The study will enroll up to 100 evaluable patients at up to 7 sites. Clinical follow up will occur at 1 month, 6 months, and 1, 2, 3, 4 and 5 years post procedure. Repeat angiography and IVUS will be performed at the 6 month follow up time point for all subjects.
Interventions
DEVICECINATRA™ Coronary Stent System
Bare metal cobalt chromium stent implantation
DEVICECINATRA™ ISA 247 Coated Coronary Stent System
Drug coated cobalt chromium stent implantation
Sponsors
Atrium Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with stable angina pectoris (Canadian Cardiovascular Society 1, 2, 3) or unstable angina pectoris with documented ischemia (CCS 4, Braunwald Class IB-C, IIB-C or IIIB-C), or patients with documented silent ischemia. 2. Patients who are eligible for coronary revascularization (percutanous angioplasty). 3. Acceptable candidates for coronary artery bypass grafting (CABG). 4. Patients with de novo lesion in a native coronary artery \>50% and \<100% stenosis. NOTE: Treatment of lesions in a non-target vessel is up to the investigator's discretion (max. two-vessel-disease). ONLY a bare metal stent (no drug eluting stent) can be used for this treatment. Treatment of any non-target vessel lesions must be successfully completed before enrolling patient and placing study stent. 5. The target lesion must be a maximum length of 13 mm (visual estimate) and able to be covered by one stent. 6. The reference diameter of the target lesion must be 3.0 mm by visual estimate. 7. Left ventricular ejection fraction of \>30%. 8. Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.
Exclusion criteria
1. Patients under the age of 18 or unable to give informed consent. 2. Women who are pregnant. Women of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable contraception at a minimum until after the angiographic follow up. 3. Patients who previously participated in this study. 4. Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. NOTE: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. 5. Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult (no fixed address, etc.). 6. Patients who intend to have a major surgical intervention within 6 months of enrollment in the study. 7. Patients with new ST elevation within 48 hours prior to stenting. 8. Braunwald Class IA, IIA and IIIA angina pectoris. 9. Patients with a contraindication to an emergency coronary bypass surgery. 10. Patients who had previous Coronary Artery Bypass Surgery (CABG). 11. Any individual who may refuse a blood transfusion. 12. Serum creatinine \>3.0 mg/dL. 13. Platelet count \<100,000 cells/mm³. 14. Patients with intolerance or contraindication to acetylsalicylic acid (aspirin), heparin, cyclosporin or cyclosporine derivative, clopidogrel or ticlopidine drug therapy. 15. Patients with contrast agent hypersensitivity that cannot be adequately pre-medicated. 16. Patients who have a stent anywhere within the target vessel. 17. Any planned interventional treatment of any vessel post study procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late Lumen Loss | 6 months |
Countries
Belgium
Outcome results
None listed