Back to resultsA Study of the Cypher Sirolimus-Eluting Stent to Treat Bifurcation Lesions. (BIFURCATION)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
drug eluting-stent
drug-eluting stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: 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; 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; Has a true bifurcation lesion defined as stenosis > 50% in both the main branch and the ostium of the side branch; Has a main branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line QCA proximal to the bifurcation; Has a side branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line QCA. Exclusion Criteria: 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; Has unstable angina classified as Braunwald A I-III, or III B or C, or is having a peri infarction; Has a bifurcation lesion in a non protected left main; Has an ejection fraction <=35%; There is presence of thrombus in the bifurcation lesion; Has a totally occluded vessel.
Sites / Locations
- Centre Cuore Columbus
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group)
stents in both the main and side branches (stent/stent group)
Outcomes
Primary Outcome Measures
percent residual diameter stenosis (%DS) in the stented branch as measured by quantitative coronary angiography (QCA)
Secondary Outcome Measures
device success defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device/treatment only
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
target vessel failure (TVF), defined as a composite of cardiac death, MI, or target vessel revascularization
lumen and obstruction volume by intravascular ultrasound (IVUS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00234455
Brief Title
A Study of the Cypher Sirolimus-Eluting Stent to Treat Bifurcation Lesions.
Acronym
BIFURCATION
Official Title
An Evaluation of the Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With Bifurcation Lesions.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
April 2007 (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 assess the feasibility and safety of the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation lesions.
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.
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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group)
Arm Title
2
Arm Type
Other
Arm Description
stents in both the main and side branches (stent/stent group)
Intervention Type
Device
Intervention Name(s)
drug eluting-stent
Other Intervention Name(s)
sirolimus-coated Bx VELOCITY Balloon-Expandable Stent
Intervention Description
PCI
Intervention Type
Device
Intervention Name(s)
drug-eluting stent
Other Intervention Name(s)
sirolimus-coated Bx VELOCITY Balloon-Expandable Stent
Intervention Description
PCI
Primary Outcome Measure Information:
Title
percent residual diameter stenosis (%DS) in the stented branch as measured by quantitative coronary angiography (QCA)
Time Frame
6-months post-procedure
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
lumen and obstruction volume by intravascular ultrasound (IVUS)
Time Frame
6-month post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
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;
Has a true bifurcation lesion defined as stenosis > 50% in both the main branch and the ostium of the side branch;
Has a main branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line QCA proximal to the bifurcation;
Has a side branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line QCA.
Exclusion Criteria:
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;
Has unstable angina classified as Braunwald A I-III, or III B or C, or is having a peri infarction;
Has a bifurcation lesion in a non protected left main;
Has an ejection fraction <=35%;
There is presence of thrombus in the bifurcation lesion;
Has a totally occluded vessel.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Colombo, MD
Organizational Affiliation
Centre Cuore Columbus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Cuore Columbus
City
Milano
ZIP/Postal Code
I-20145
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
A Study of the Cypher Sirolimus-Eluting Stent to Treat Bifurcation Lesions.
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