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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Balloon-Stent Kissing technique
Jailed Wire technique
Sponsored by
Dalian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Balloon-Stent Kissing technique

Jailed Wire technique

Arm 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.

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.

Outcomes

Primary Outcome Measures

Perioperative major adverse cardiovascular (MACE) events (%)
total percent of cardiac death, perioperative myocardial infarction and target lesion revascularization

Secondary Outcome Measures

long-term clinical outcomes(%)
total percent of angina pectoris, CCS classification ≥Ⅱ level and severe heart failure (NYHA class),cardiac death, perioperative myocardial infarction and target lesion revascularization

Full Information

First Posted
January 4, 2018
Last Updated
February 5, 2018
Sponsor
Dalian University
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1. Study Identification

Unique Protocol Identification Number
NCT03429634
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
May 1, 2016 (Actual)
Study Completion Date
July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dalian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balloon-Stent Kissing technique
Arm Type
Experimental
Arm 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.
Arm Title
Jailed Wire technique
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Balloon-Stent Kissing technique
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Jailed Wire technique
Intervention Description
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
Primary Outcome Measure Information:
Title
Perioperative major adverse cardiovascular (MACE) events (%)
Description
total percent of cardiac death, perioperative myocardial infarction and target lesion revascularization
Time Frame
up to 72hr after PCI
Secondary Outcome Measure Information:
Title
long-term clinical outcomes(%)
Description
total percent of angina pectoris, CCS classification ≥Ⅱ level and severe heart failure (NYHA class),cardiac death, perioperative myocardial infarction and target lesion revascularization
Time Frame
post-PCI to mean 19 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhenguo Zheng, Dr.
Organizational Affiliation
zhongshan Hospital affiliated to dalian University
Official's Role
Study Director
Facility Information:
Facility Name
Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25256198
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov
Description
Consensus Development Conference

Learn more about this trial

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

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