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The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent
This study has been completed.
First Received: October 4, 2005   Last Updated: October 8, 2007   History of Changes
Sponsored by: Cordis Corporation
Information provided by: Cordis Corporation
ClinicalTrials.gov Identifier: NCT00232804
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Bx Cypher stent
Phase IV

MedlinePlus related topics: Coronary Artery Disease
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Safety and Efficacy Registry of Bx Cypher Stent in the Revascularisation of Patients With Significant Risk of Restenosis

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • MACE. [ Time Frame: 1, 6, and 12 months post-procedure ]

Enrollment: 639
Study Start Date: June 2002
Study Completion Date: February 2004
Arms Assigned Interventions
1 Device: Bx Cypher stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232804

Locations
France
Université de Lille, Hôpital cardiologique
Lille, France, 59037
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Lablanche, Prof. Université de Lille, Hôpital cardiologique
  More Information

Publications:
Study ID Numbers: 01290402
Study First Received: October 4, 2005
Last Updated: October 8, 2007
ClinicalTrials.gov Identifier: NCT00232804     History of Changes
Health Authority: France: AFSSAPS - Agence Française de Sécurité Sanitaire des Produits de Santé - French Safety Medical Agency of the Health Care products

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009