A Phase 4 interventional study of Crush technique and provisional T stenting in Coronary Artery Disease, sponsored by Seung-Jung Park. Completed at 12 sites in South Korea. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-11-17.
Sponsored by Seung-Jung Park · Phase 4, Interventional, and Treatment
It is unclear which stenting strategy will be optimal for true bifurcation coronary lesions.
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.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 420 is above the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
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Clinical
Angiographic
Exclusion Criteria:
Characteristics of lesion:
crush technique
Procedure: Crush technique
provisional T stenting
Procedure: provisional T stenting
Crush technique
Also known as: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents
Provisional T stenting
Also known as: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents
Angiographic binary restenosis rate (diameter stenosis >= 50%) at 8 months in either main or side branch
Time frame: 8 months
Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and ischemia-driven target vessel revascularization
Time frame: 2 years
Reocclusion rate at the side branch at 8 month angiographic follow-up
Time frame: 8 months
Late loss at the main vessel and the side branch
Time frame: 8 months
Restenosis rate at the main vessel and/or side branch
Time frame: 8 months
Influence of bifurcation angle
Time frame: 8 months
Influence of new three segment bifurcation QCA software
Time frame: 8 months
Fluoroscopic time
Time frame: baseline
Procedure time
Time frame: baseline
Amount of contrast agent
Time frame: baseline
Number of used stents
Time frame: baseline
FFR assessment in the side branch
Time frame: baseline and 8 months
The record gives a start of Jan 2008, a primary completion of Jun 2015 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.
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Seung-Jung Park