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

Coronary Artery Disease Clinical Trial

Official title:

Safety and Efficacy Registry of Bx Cypher Stent in the Revascularisation of Patients With Significant Risk of Restenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232804
• Other study ID #: 01290402
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2005
• Last updated: October 8, 2007
• Start date: June 2002
• Est. completion date: February 2004

Study information

• Verified date: October 2007
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: AFSSAPS - Agence Française de Sécurité Sanitaire des Produits de Santé - French Safety Medical Agency of the Health Care products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 639
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Bx Cypher stent

Locations

Country	Name	City	State
France	Université de Lille, Hôpital cardiologique	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

France, 

References & Publications (1)

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 Cardi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE.		1, 6, and 12 months post-procedure