Status:
UNKNOWN
Treatment of Bifurcated Coronary Lesions With Cypher™-Stent
Lead Sponsor:
University Heart Center Freiburg - Bad Krozingen
Collaborating Sponsors:
Cordis, Johnson&Johnson company
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is a prospective, randomized, single-center evaluation of the Cypher™ Sirolimus eluting coronary stent system in the treatment of de novo bifurcated coronary lesions comparing provisional m...
Detailed Description
Bifurcations involving a significant side branch (SB diameter ≥ 2.25 mm) occur in approximately 15-20% of all coronary lesions considered for percutaneous intervention. If a side branch (SB) subtends ...
Eligibility Criteria
Inclusion
- 1\. The target vessel must meet the following criteria:
- Bifurcated lesion Type 1, 2, 3 or 4 of a native coronary artery with a reference vessel diameter of 2.5 mm to 4.0 mm in the main branch and of ≥ 2.25 mm in the side branch.
- The target lesion (main branch and / or side branch) must be at least 50% diameter stenosis.
- The target lesion has not been previously treated with any interventional procedure.
- The target vessel (main branch and side branch) must be feasible for stent implantation (successful passage with the guide wire; successful predilatation with an appropriately sized balloon; no heavy calcification; no diffuse distal disease that might impede run off).
- 2\. Patient has stable or unstable angina pectoris (CCS classification I or greater) or a positive stress test for ischemia.
- 3\. Patient must be ≥ 18 years of age. 4. Female subjects of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
- 5\. Patient has no other treatment planned within 30 days of the procedure. 6. Patient has been informed of the nature of the study and agrees to its provisions and has written informed consent as approved by the Ethics Committee.
- 7\. Patient willing to comply with required post-procedure follow-up.
Exclusion
- 1\. Patient has had an acute myocardial infarction (\> 3x normal CK with presence of CKMB) within 72 hours preceding the index procedure and CK has not returned to normal limits at the time of the procedure.
- 2\. Patient will have a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel, sirolimus, or contrast sensitivity that cannot be adequately pre-medicated.
- 3\. Patient has a platelet count of \<100,000 cells/mm³ or \>700,000 cells/mm³, a WBC of \<3,000 cells/mm³, or documented or suspected liver disease.
- 4\. Patient has a history of bleeding diathesis or coagulopathy. 5. Patient has suffered a CVA or TIA within the past six months. 6. Active peptic ulcer or upper GI bleeding within the prior 6 months. 7. Patient has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life- expectancy (less than 2 years).
- 8\. Patient must be excluded from the study if any of these angiographic criteria are met:
- The target vessel contains intraluminal thrombus.
- The target lesion is located in the left main coronary artery.
- The target lesion or vessel shows angiographic evidence of severe calcification.
- The patient has undergone previous PCI to the target vessel within 6 months.
- Pre treatment of the lesion is done with a technique other than balloon angioplasty (e.g. rotablation).
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00288535
Start Date
March 1 2005
End Date
February 1 2007
Last Update
September 18 2007
Active Locations (1)
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1
Herz-Zentrum Bad Krozingen
Bad Krozingen, Suedring 15, Germany, 79189