NCT00693251

Optimal Stenting Strategy For True Bifurcation Lesions

Phase IV Study of Optimal Stenting Strategy For True Bifurcation Lesions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Seung-Jung Park · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

It is unclear which stenting strategy will be optimal for true bifurcation coronary lesions.

Detailed description

The outcome of percutaneous coronary intervention of bifurcation lesions with bare-metal stents is hindered by increased rates of procedural complications and long-term major adverse cardiac events compared with non-bifurcated lesions.1 Randomized studies have demonstrated that drug-eluting stents reduce restenosis when used in relatively simple lesions; and recent data have demonstrated efficacy of the sirolimus-eluting stent for bifurcation lesions compared with historical data of BMS. In one study of bifurcation lesions, the overall restenosis rate was 23%, with the majority of side branch restenoses occurring at the ostium after use of a T-stenting technique. Indeed, side branch restenosis occurred in 16.7% after T-stenting, compared with 7.1% after other stenting techniques. The "crush" technique of bifurcation stenting with DESs was introduced by Colombo et al. in 2003 as a relatively simple technique that ensures complete coverage of the side branch ostium, thereby facilitating drug delivery at this site. Initial data of 20 patients treated with this technique with SES suggest that it is a safe method, with an acceptable rate of procedural complications and no further adverse events up to 30 days follow-up. Recently, angiographic data have shown the importance of simultaneous kissing balloon post-dilation in reducing restenosis and need for target lesion revascularization. They also reported that compared to T-stenting, crushing with final kissing balloon dilatation was associated with lower rate of restenosis and target lesion revascularization. Consequently, the crushing is currently most promising technique in treating bifurcation lesions using two stents. However, despite the advance of bifurcation stenting technique, the superiority of bifurcation stenting with crushing technique over simple stenting in bifurcation lesion has not been demonstrated. Therefore, we conducted the prospective randomized study comparing crushing technique with final kissing balloon dilatation and a simple technique (main vessel stenting and provisional T-stenting) for treatment of true bifurcation lesions.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Crush technique	Crush technique
PROCEDURE	provisional T stenting	Provisional T stenting

Timeline

• Start date: 2008-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2008-06-09
• Last updated: 2015-11-17

Locations

12 sites across 1 country: South Korea