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The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00232804
First Posted: October 5, 2005
Last Update Posted: October 10, 2007
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.
Information provided by:
Cordis Corporation
October 4, 2005
October 5, 2005
October 10, 2007
June 2002
Not Provided
MACE. [ Time Frame: 1, 6, and 12 months post-procedure ]
MACE at 1, 6, and 12 months post-procedure.
Complete list of historical versions of study NCT00232804 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent
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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
Device: Bx Cypher stent
1
Intervention: Device: Bx Cypher stent
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.
 
Completed
639
February 2004
Not Provided

Inclusion Criteria:

  1. NIDDM treated with oral antidiabetics for at least 3 months, or IDDM treated for at least 3 months with documented HbA1C;
  2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B I-II) OR patients with documented silent ischemia;
  3. Target lesion stenosis is >50% (visual estimate);
  4. Target vessel diameter, between 2.5 and 3.0 mm
  5. Target lesion length minimum 15 mm and maximum 30mm

Exclusion Criteria:

  1. CK and CK-MB enzymes above normal or elevated troponin level (as determined by site criteria) at the time of treatment;
  2. Has unstable angina classified as Braunwald III B and A or C I-II-III, or is having a peri-infarction;
  3. Unprotected left main coronary disease with >=50% stenosis;
  4. Significant (>50%) stenosis proximal or distal to the target lesion that might impede inflow or runoff and can not be revascularized before or during the index procedure;
  5. Have an ostial target lesion;
  6. Documented left ventricular ejection fraction <=30%;
  7. In-Stent restenosis;
  8. Chronic total occlusion.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00232804
01290402
Yes
Not Provided
Not Provided
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Cordis Corporation
Not Provided
Principal Investigator: Lablanche, Prof. Université de Lille, Hôpital cardiologique
Cordis Corporation
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP