Treatment of Bifurcated Coronary Lesions With Cypher™-Stent
Recruitment status was Recruiting
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.
Coronary Artery Disease
Procedure: PCI of bifurcated coronary lesions using sirolimus coated stents in modified T-Stenting -Technique
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective, Randomized, Single-Center Evaluation of the Cypher™ Sirolimus Eluting Coronary Stent System in the Treatment of Bifurcated Coronary Lesions|
- In-segment percent diameter stenosis of the side branch at 9 months post procedure as measured by quantitative coronary angiography.
- Freedom from Major Adverse Cardiac Events (MACE)at 30 days, 6 and 12 months
- Angiographic binary restenosis (≥ 50% diameter stenosis) in the main and side branch at 9 months post procedure.
- Target Lesion Revascularization (TLR) at 12 months post procedure.
- Device success during PCI
- Post-procedure thrombotic stent occlusion at 12 months
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||February 2007|
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.
|Contact: Miroslaw Ferenc, Dr.||0049 7633 4020||Miroslaw.Ferenc@herzzentrum.de|
|Contact: Franz-Josef Neumann, Prof. Dr.||0049 7633 4020||Franz-Josef.Neumann@herzzentrum.de|
|Herz-Zentrum Bad Krozingen||Recruiting|
|Bad Krozingen, Suedring 15, Germany, 79189|
|Contact: Miroslaw Ferenc, Dr. 0049 7633 4020 Miroslaw.Ferenc@herzzentrum.de|
|Contact: Franz-Josef Neumann, Prof. Dr. 0049 7633 4020 Franz-Josef.Neumann@herzzentrum.de|
|Principal Investigator:||Miroslaw FERENC, Dr.||Haert Center Bad Krozingen; Germany|
|Study Director:||Franz-Josef Neumann, Prof. Dr.||Heart Center Bad Krozingen, Germany|