The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent
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|ClinicalTrials.gov Identifier: NCT00232804|
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : October 10, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: Bx Cypher stent||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||639 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Registry of Bx Cypher Stent in the Revascularisation of Patients With Significant Risk of Restenosis|
|Study Start Date :||June 2002|
|Actual Study Completion Date :||February 2004|
Device: Bx Cypher stent
- MACE. [ Time Frame: 1, 6, and 12 months post-procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232804
|Université de Lille, Hôpital cardiologique|
|Lille, France, 59037|
|Principal Investigator:||Lablanche, Prof.||Université de Lille, Hôpital cardiologique|