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
About this trial
This is an interventional treatment trial for Coronary Artery Disease
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)
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
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
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Balloon-Stent Kissing Technique Versus Jailed Wire Technique for the Coronary Bifurcation Lesions
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