Treatment of Bifurcated Coronary Lesions With Cypher™-Stent
Recruitment status was Recruiting
|First Received Date ICMJE||February 7, 2006|
|Last Updated Date||September 17, 2007|
|Start Date ICMJE||March 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||In-segment percent diameter stenosis of the side branch at 9 months post procedure as measured by quantitative coronary angiography.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00288535 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Treatment of Bifurcated Coronary Lesions With Cypher™-Stent|
|Official Title ICMJE||Prospective, Randomized, Single-Center Evaluation of the Cypher™ Sirolimus Eluting Coronary Stent System in the Treatment of Bifurcated Coronary Lesions|
This study is a prospective, randomized, single-center evaluation of the Cypher™ Sirolimus eluting coronary stent system in the treatment of de novo bifurcated coronary lesions comparing provisional modified T stenting with systematic modified T-stenting.
Bifurcations involving a significant side branch (SB diameter ≥ 2.25 mm) occur in approximately 15-20% of all coronary lesions considered for percutaneous intervention. If a side branch (SB) subtends significant myocardium, failure to preserve SB vessel patency can lead to complications such as myocardial infarction or persistent chest pain despite full patency of the main branch.
Bifurcation lesions are inherently complex and interventional treatment remains a challenging problem for physicians.
The optimal technique for stenting bifurcated lesions is still unknown. Several dual vessel stenting techniques have been described in the literature, such as "T", "V", "Y", "Culotte" and "Crush" procedures. However, most studies of bifurcation stenting have found that optimal long-term results are obtained by stenting the main vessel and then performing plain balloon angioplasty of the side branch ("kissing balloon"-technique). Nevertheless, occlusion or reduced flow of the SB are frequent after stenting of the MB. Therefore, the SB is stented in approximately 50% of procedures even if PTCA alone was intended.
Compared with plain dilatation of side branch, the placement of Cypher-Stent in side branch using modified T-stenting technique will reduce "in-segment percent diameter stenosis" of the side branch at 9 months post procedure as measured by quantitative coronary angiography.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Coronary Artery Disease|
|Intervention ICMJE||Procedure: PCI of bifurcated coronary lesions using sirolimus coated stents in modified T-Stenting -Technique|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||200|
|Completion Date||February 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Germany|
|NCT Number ICMJE||NCT00288535|
|Other Study ID Numbers ICMJE||HZ-BK-2005-1|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Heart Center Bad Krozingen|
|Collaborators ICMJE||Cordis, Johnson&Johnson company|
|Information Provided By||Heart Center Bad Krozingen|
|Verification Date||March 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP