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

NCT00232804 | Completed Phase 4 DMC

• 1 other identifier: 01290402
• Study Type: interventional
• Target: 639
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• MACE.

  1, 6, and 12 months post-procedure

Study Arms (1)

1

OTHER

Device: Bx Cypher stent

Interventions

Bx Cypher stent DEVICE

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Université de Lille, Hôpital cardiologique

Lille, 59037, France

Location

Related 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 Cardiol Angeiol (Paris). 2004 May;53 Suppl 1:29s-31s. doi: 10.1016/s0003-3928(04)90006-6. No abstract available. French.

  PMID: 15291158 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Lablanche, Prof.

  Université de Lille, Hôpital cardiologique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 5, 2005
• Study Start: June 1, 2002
• Study Completion: February 1, 2004
• Last Updated: October 10, 2007

Record last verified: 2007-10

Locations

FR (1)