Back to resultsThe BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Bx Cypher stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: NIDDM treated with oral antidiabetics for at least 3 months, or IDDM treated for at least 3 months with documented HbA1C; 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; Target lesion stenosis is >50% (visual estimate); Target vessel diameter, between 2.5 and 3.0 mm Target lesion length minimum 15 mm and maximum 30mm Exclusion Criteria: CK and CK-MB enzymes above normal or elevated troponin level (as determined by site criteria) at the time of treatment; Has unstable angina classified as Braunwald III B and A or C I-II-III, or is having a peri-infarction; Unprotected left main coronary disease with >=50% stenosis; 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; Have an ostial target lesion; Documented left ventricular ejection fraction <=30%; In-Stent restenosis; Chronic total occlusion.
Sites / Locations
- Université de Lille, Hôpital cardiologique
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
MACE.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00232804
Brief Title
The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent
Official Title
Safety and Efficacy Registry of Bx Cypher Stent in the Revascularisation of Patients With Significant Risk of Restenosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
639 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Bx Cypher stent
Primary Outcome Measure Information:
Title
MACE.
Time Frame
1, 6, and 12 months post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
NIDDM treated with oral antidiabetics for at least 3 months, or IDDM treated for at least 3 months with documented HbA1C;
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;
Target lesion stenosis is >50% (visual estimate);
Target vessel diameter, between 2.5 and 3.0 mm
Target lesion length minimum 15 mm and maximum 30mm
Exclusion Criteria:
CK and CK-MB enzymes above normal or elevated troponin level (as determined by site criteria) at the time of treatment;
Has unstable angina classified as Braunwald III B and A or C I-II-III, or is having a peri-infarction;
Unprotected left main coronary disease with >=50% stenosis;
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;
Have an ostial target lesion;
Documented left ventricular ejection fraction <=30%;
In-Stent restenosis;
Chronic total occlusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lablanche, Prof.
Organizational Affiliation
Université de Lille, Hôpital cardiologique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Lille, Hôpital cardiologique
City
Lille
ZIP/Postal Code
59037
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
15291158
Citation
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. doi: 10.1016/s0003-3928(04)90006-6. No abstract available. French.
Results Reference
result
Learn more about this trial
The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent
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