The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00232804|
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : October 10, 2007
|First Submitted Date ICMJE||October 4, 2005|
|First Posted Date ICMJE||October 5, 2005|
|Last Update Posted Date||October 10, 2007|
|Study Start Date ICMJE||June 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||MACE. [ Time Frame: 1, 6, and 12 months post-procedure ]|
|Original Primary Outcome Measures ICMJE
||MACE at 1, 6, and 12 months post-procedure.|
|Change History||Complete list of historical versions of study NCT00232804 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent|
|Official Title ICMJE||Safety and Efficacy Registry of Bx Cypher Stent in the Revascularisation of Patients With Significant Risk of Restenosis|
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.
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 ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Coronary Artery Disease|
|Intervention ICMJE||Device: Bx Cypher stent|
Intervention: Device: Bx Cypher stent
|Publications *||Lablanche JM, Commeau P; Investigateurs du Registre BRIDGE. [BRIDGE registry (safety and efficacy registry Bx Cyper stent in the RevascularIzation of patients with siGnificative risk of rEstenosis): protocol description and preliminary results]. Ann Cardiol Angeiol (Paris). 2004 May;53 Suppl 1:29s-31s. French.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Enrollment ICMJE
|Actual Study Completion Date||February 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||France|
|Removed Location Countries|
|NCT Number ICMJE||NCT00232804|
|Other Study ID Numbers ICMJE||01290402|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Cordis Corporation|
|Collaborators ICMJE||Not Provided|
|PRS Account||Cordis Corporation|
|Verification Date||October 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP