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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

October 5, 2005
April 28, 2008
June 2001
October 2002   (final data collection date for primary outcome measure)
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 ]
The primary endpoint is percent residual diameter stenosis (%DS) in the stented branch as measured by quantitative coronary angiography (QCA) at six months post-procedure
Complete list of historical versions of study NCT00234455 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
A Study of the Cypher Sirolimus-Eluting Stent to Treat Bifurcation Lesions.
An Evaluation of the Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With Bifurcation Lesions.

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: drug eluting-stent
    PCI
    Other Name: sirolimus-coated Bx VELOCITY Balloon-Expandable Stent
  • Device: drug-eluting stent
    PCI
    Other Name: sirolimus-coated Bx VELOCITY Balloon-Expandable Stent
  • 1
    stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group)
    Intervention: Device: drug eluting-stent
  • 2
    stents in both the main and side branches (stent/stent group)
    Intervention: Device: drug-eluting stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
April 2007
October 2002   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00234455
EC01-02
Yes
Dr. Hans-Peter Stoll - Medical Affairs Director, Cordis
Cordis Corporation
Not Provided
Principal Investigator: Antonio Colombo, MD Centre Cuore Columbus
Cordis Corporation
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP