Balloon-Stent Kissing Technique Versus Jailed Wire Technique for the Coronary Bifurcation Lesions

Early Phase 1

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT03429634
• Lead Sponsor: Dalian University

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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2016-05-01
• Study Completion: 2017-07-01
• Study First Submitted: 2018-01-04
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-05
• Last Update Submitted: 2018-02-05
• Study First Posted: 2018-02-12
• Last Update Posted: 2018-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Perioperative major adverse cardiovascular (MACE) events （%）	up to 72hr after PCI	total percent of cardiac death, perioperative myocardial infarction and target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
long-term clinical outcomes（%）	post-PCI to mean 19 month follow up	total percent of angina pectoris, CCS classification ≥Ⅱ level and severe heart failure (NYHA class),cardiac death, perioperative myocardial infarction and target lesion revascularization

Trial Locations

Locations (1)

Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University; 🇨🇳 Dalian, Liaoning, China