The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent
The objective of this study is to establish the safety and efficacy of the treatment with Cypher DES in diabetic patients with documented ischemia due to stenosis (small coronary artery 2.5 -3 mm in lumen diameter, with lesion between 15 mm 30 mm in length, ) in native coronary arteries.
The objective of this study is to document that the use of Cypher DES in these diabetic patients undergoing percutaneous revascularization for stenosis is safe.
Safety will be assessed over a period of 12 months.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy Registry of Bx Cypher Stent in the Revascularisation of Patients With Significant Risk of Restenosis|
- MACE. [ Time Frame: 1, 6, and 12 months post-procedure ]
|Study Start Date:||June 2002|
|Study Completion Date:||February 2004|
This is a prospective, multicenter, comparative, non randomised, open registry of 1000 patients who will be followed up to 12 months at 100 sites in France.
Patients will be screened according to normal practice and in relation to the inclusion and exclusion criteria. Patients should have a documented ischemia related to the target vessel.
Procedure of stent placement should be done under existing in hospital procedural protocol and care should be taken to follow Cordis instructions as set forth in the Instructions For Use.
Follow up will be done according to normal procedure and the minimum should be a telephone contact at 1, 6 and 12 months.
All data gathered during the enrollment, procedure, follow up and when specific events to the patient may occur, will be entered into the Internet CRF form, by the treating physician or a person from his staff specifically appointed to this task.
Patient enrollment is anticipated to last 8 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232804
|Université de Lille, Hôpital cardiologique|
|Lille, France, 59037|
|Principal Investigator:||Lablanche, Prof.||Université de Lille, Hôpital cardiologique|