Clinical trial NCT03429634: Balloon-Stent Kissing Technique Versus Jailed Wire Technique for the Coronary Bifurcation Lesions
Official title: Comparative Study of Balloon-Stent Kissing Technique Versus Jailed Wire Technique for the Interventional Treatment of Coronary Bifurcation Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Coronary Artery Disease
Lead sponsor: Dalian University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 1. patients with CHD; 2. coronary arteriography revealed true bifurcation lesion

Exclusion Criteria:

* 1. severe carcified lesion; 2. left main lesion; 3. severe heart failure(NYHA grade 4)

Primary outcomes:
measure: Perioperative major adverse cardiovascular (MACE) events （%）
timeFrame: up to 72hr after PCI
Secondary outcomes:
measure: long-term clinical outcomes（%）
timeFrame: post-PCI to mean 19 month follow up
Other outcomes:
Locations:
city: Dalian
country: China
facility: Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University
state: Liaoning
Study officials:
affiliation: zhongshan Hospital affiliated to dalian University
name: zhenguo Zheng, Dr.
role: STUDY_DIRECTOR
References:
citation: Lassen JF, Holm NR, Stankovic G, Lefevre T, Chieffo A, Hildick-Smith D, Pan M, Darremont O, Albiero R, Ferenc M, Louvard Y. Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings. EuroIntervention. 2014 Sep;10(5):545-60. doi: 10.4244/EIJV10I5A97.