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

NCT03429634 | Completed Early Phase 1

• 1 other identifier: DalianU
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Perioperative major adverse cardiovascular (MACE) events （%）

  total percent of cardiac death, perioperative myocardial infarction and target lesion revascularization

  up to 72hr after PCI

Secondary Outcomes (1)

• long-term clinical outcomes（%）

  post-PCI to mean 19 month follow up

Study Arms (2)

Balloon-Stent Kissing technique

EXPERIMENTAL

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

Jailed Wire technique

SHAM COMPARATOR

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

Interventions

Balloon-Stent Kissing technique PROCEDURE

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

Balloon-Stent Kissing technique; Jailed Wire technique

Jailed Wire technique PROCEDURE

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

Balloon-Stent Kissing technique; Jailed Wire technique

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. patients with CHD; 2. coronary arteriography revealed true bifurcation lesion

You may not qualify if:

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

Sponsors & Collaborators

• Dalian University: lead

Study Sites (1)

Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University

Dalian, Liaoning, 116001, China

Location

Related Publications (1)

• 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.

  PMID: 25256198 RESULT

Related Links

• Consensus Development Conference

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• zhenguo Zheng, Dr.

  zhongshan Hospital affiliated to dalian University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: February 12, 2018
• Study Start: January 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2017
• Last Updated: February 12, 2018

Record last verified: 2018-02

Locations

CN (1)