An Early Phase 1 interventional study of Balloon-Stent Kissing technique and Jailed Wire technique in Coronary Artery Disease, sponsored by Dalian University. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-02-12.
Sponsored by Dalian University · Early Phase 1, Interventional, and Treatment
To compare the immediate and long-term clinical outcomes between Balloon-Stent Kissing Technique (BSKT) and Jailed Wire Technique (JWT) for the interventional treatment of coronary bifurcation lesions.
Coronary bifurcation lesions account for 15-20% of percutaneous coronary interventions (PCIs)[1-2]. They have lower success rate after operation, higher re-stricture ratio by radiography and frequent complications, which result in adverse clinical outcomes as compared to non-bifurcation lesions[3-5]. Secure and efficient treatment strategies for PCI and bifurcation lesions are research hotspots for cardiovascular surgeons. Single-side stand strategy (main-support implantation stand or side-support implantation stand when necessary) is currently preferred for bifurcation lesions[2,6]. However, as main-support implantation stand could lead to plaque transposition, bifurcation ridge excursion and side a sandwich, the side openings could become narrower or even blocked[7]. In 2011, our centre initiated the use of balloon-stent kissing technique (BSKT)[8] to protect the side branch, which has higher success rate after operation, lower block ratio of side branch and lower incidence of perioperative adverse events, which led to immediate clinical effect. This study compared BSKT versus Jailed Wire Technique (JWT) in the interventional treatment of coronary bifurcation lesions to further clarify BSKT's efficacy and advantages.
Exclusion Criteria:
randomly, patients with bifurcation lesion treated by Balloon-Stent Kissing intervention technique in this group.For procedure,stent in main vessel and balloon protect of side branch,final kiss-balloon was performed.
Procedure: Balloon-Stent Kissing technique · Procedure: Jailed Wire technique
randomly,patients with bifurcation lesion treated by Jailed Wire intervention technique in this group.For procedure,stent in main vessel and only wire protect of side branch.If need,post-stent rewire of branch,and balloon dilation of side branch was performed.
Procedure: Balloon-Stent Kissing technique · Procedure: Jailed Wire technique
All patients underwent coronary angiogram that confirmed true bifurcation lesions, and received PCI treatment,Balloon-Stent Kissing Technique (BSKT)for the interventional treatment of coronary bifurcation lesion
All patients underwent coronary angiogram that confirmed true bifurcation lesions, and received PCI treatment, Jailed Wire technique(JWT) for the interventional treatment of coronary bifurcation lesion
Perioperative major adverse cardiovascular (MACE) events （%）
total percent of cardiac death, perioperative myocardial infarction and target lesion revascularization
Time frame: up to 72hr after PCI
long-term clinical outcomes（%）
total percent of angina pectoris, CCS classification ≥Ⅱ level and severe heart failure (NYHA class),cardiac death, perioperative myocardial infarction and target lesion revascularization
Time frame: post-PCI to mean 19 month follow up
Plan to share: Undecided
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Dalian University