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

Coronary Artery Disease Clinical Trial

Official title:

Comparative Study of Balloon-Stent Kissing Technique Versus Jailed Wire Technique for the Interventional Treatment of Coronary Bifurcation Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429634
• Other study ID #: DalianU
• Status: Completed
• Phase: Early Phase 1
• First received: January 4, 2018
• Last updated: February 5, 2018
• Start date: January 1, 2013
• Est. completion date: July 1, 2017

Study information

• Verified date: February 2018
• Source: Dalian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 1, 2017
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Balloon-Stent Kissing 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
• Jailed Wire technique
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

Locations

Country	Name	City	State
China	Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Dalian University

Country where clinical trial is conducted

China, 

References & Publications (1)

Lassen JF, Holm NR, Stankovic G, Lefèvre 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative major adverse cardiovascular (MACE) events (%)	total percent of cardiac death, perioperative myocardial infarction and target lesion revascularization	up to 72hr after PCI
Secondary	long-term clinical outcomes(%)	total percent of angina pectoris, CCS classification =? level and severe heart failure (NYHA class),cardiac death, perioperative myocardial infarction and target lesion revascularization	post-PCI to mean 19 month follow up

External Links

•   Consensus Development Conference