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

Dalian University

Status and phase: Completed; Early Phase 1

Conditions: Coronary Artery Disease

Treatments: Procedure: Balloon-Stent Kissing technique; Procedure: Jailed Wire technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03429634

DalianU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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89 participants in 2 patient groups

Balloon-Stent Kissing technique

Experimental group

Description:

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.

Treatment:

Procedure: Balloon-Stent Kissing technique

Procedure: Jailed Wire technique

Jailed Wire technique

Sham Comparator group

Description:

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.

Treatment:

Procedure: Balloon-Stent Kissing technique

Procedure: Jailed Wire technique