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A Study of the Cypher Sirolimus-Eluting Stent to Treat Bifurcation Lesions. (BIFURCATION)

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00234455
First received: October 5, 2005
Last updated: April 28, 2008
Last verified: April 2008
History of Changes
  Purpose

The objective of this study is to assess the feasibility and safety of the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation lesions.


Condition Intervention Phase
Coronary Artery Disease
 Device: drug eluting-stent
Device: drug-eluting stent
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Evaluation of the Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With Bifurcation Lesions.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • percent residual diameter stenosis (%DS) in the stented branch as measured by quantitative coronary angiography (QCA) [ Time Frame: 6-months post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • device success defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device/treatment only [ Time Frame: anytime during the course of the study ] [ Designated as safety issue: Yes ]
  • procedure success defined as achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, myocardial infarction (MI), or repeat revascularization of the target lesion during the hospital stay [ Time Frame: anytime during the course of the study ] [ Designated as safety issue: Yes ]
  • target vessel failure (TVF), defined as a composite of cardiac death, MI, or target vessel revascularization [ Time Frame: 6, 12, 18, and 24 months post-procedure ] [ Designated as safety issue: Yes ]
  • lumen and obstruction volume by intravascular ultrasound (IVUS) [ Time Frame: 6-month post-procedure ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: June 2001
Study Completion Date: April 2007
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group)
 Device: drug eluting-stent
PCI
Other Name: sirolimus-coated Bx VELOCITY Balloon-Expandable Stent
2
stents in both the main and side branches (stent/stent group)
 Device: drug-eluting stent
PCI
Other Name: sirolimus-coated Bx VELOCITY Balloon-Expandable Stent

Detailed Description:

This is a prospective, randomized study that will be conducted at up to 5 centers in Europe and the US. All patients who meet the eligibility criteria will be treated with the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent and Stent Delivery System (SDS). As a secondary objective, patients will be randomized in a 1:1 ratio to receive one stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group), or to receive stents in both the main and side branches (stent/stent group). It is anticipated that up to 70% of the patients enrolled in the stent/PTCA group will be considered treatment failures and require a stent in the side branch. These patients will have a sirolimus-coated stent placed in the side branch and will be followed per the protocol, but will be analyzed separately. Therefore, it is anticipated that up to 75 patients will be enrolled in the trial. All patients will have repeat angiography at six months, with clinical follow-up to 5 years.

  Eligibility

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

Inclusion Criteria:

  1. Has a diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR has documented silent ischemia;
  2. Involves a single treatment of a de novo bifurcation lesion in native coronary arteries of patients with single or multivessel disease; patients with multiple lesions can be included only if other lesions treated during the index procedure are successfully treated prior to the treatment of the bifurcation lesion;
  3. Has a true bifurcation lesion defined as stenosis > 50% in both the main branch and the ostium of the side branch;
  4. Has a main branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line QCA proximal to the bifurcation;
  5. Has a side branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line QCA.

Exclusion Criteria:

  1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented elevation of CK levels > 2 times normal or CK-MB levels > 3 times normal within the preceding 24 hours and/or the CK and CK-MB enzymes remain above normal at the time of treatment;
  2. Has unstable angina classified as Braunwald A I-III, or III B or C, or is having a peri infarction;
  3. Has a bifurcation lesion in a non protected left main;
  4. Has an ejection fraction <=35%;
  5. There is presence of thrombus in the bifurcation lesion;
  6. Has a totally occluded vessel.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234455

Locations
Italy
Centre Cuore Columbus
Milano, Italy, I-20145
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Antonio Colombo, MD Centre Cuore Columbus
  More Information

No publications provided

Responsible Party: Dr. Hans-Peter Stoll - Medical Affairs Director, Cordis
ClinicalTrials.gov Identifier: NCT00234455     History of Changes
Other Study ID Numbers: EC01-02
Study First Received: October 5, 2005
Last Updated: April 28, 2008
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 22, 2013