Jailed-balloon Technique in Coronary Bifurcation Lesion PCI (JBTinCBL)

June 17, 2014 updated by: Guangdong Provincial People's Hospital

Effect of Jailed-Balloon Technique in Percutaneous Coronary Intervention for Non-Left Main Coronary Bifurcation Lesions: A Prospective, Randomized Study.

This study aims to test the hypothesis that jailed-balloon technique(JBT) is superior to jailed-wire technique(JWT) in non-left main coronary bifurcation percutaneous coronary intervention(PCI) by lowering the risk of side branch(SB) loss and PCI related myocardial infarction, as well as 1-year major adverse cardiovascular events(MACEs).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Objective: To compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
  2. Background: Solid evidence is scant to compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
  3. Study design: This is a multi-center, prospective, randomized study.
  4. Methods

4a. Study populations: Patients with non-left main coronary bifurcation lesions(Medina 1,1,1 ), which SBs are less than 2.5mm and more than 1mm, are enrolled in this study. Patients are randomized to JBT group and JWT group.

4b. Procedure: For patients enrolled in JBT group, a monorail balloon is placed at the ostium of SB to protect the SB before the stent in main branch(MB) is deployed. Only a PTCA wire would be placed in the SB while stenting MB for patients randomized in JWT group. Only drug-eluting stent should be implanted in the target vessel.

Study Type

Interventional

Enrollment (Anticipated)

410

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518020
        • Shenzhen People's Hospital
    • Xinjiang
      • Kashgar, Xinjiang, China, 844000
        • Kashgar District 1st People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥18 years and ≤75 years;
  2. De novo Medina 1,1,1 coronary bifurcation with a main branch(MB) >2.5mm while side branch <2.5mm and >1.5mm;
  3. Only one bifurcation lesion need to be treated in one vessel;
  4. The target lesion in MB has stenosis more than 75% or fractional flow reserve(FFR) less than 0.75 and the stenosis in SB ostium is more than 50%;
  5. Signed consent is obtained.

Exclusion Criteria:

  1. Left ventricular ejection fraction(LVEF) less than 30%;
  2. Hemodynamic instability or cardiac shock;
  3. Myopathy or muscular injury with elevation of creatine kinase to more than 3mg/dL;
  4. Tumor with expected survival less than 1 year;
  5. Autoimmune disease;
  6. Active gastrointestinal bleeding or any contraindication for dual antiplatelet therapy;
  7. Acute coronary syndrome require emergency PCI;
  8. Coronary bifurcation need to be treated with two-stent strategy;
  9. Not suitable for drug-eluting stent(DES) implantation;
  10. Mental disorder or alcohol dependence;
  11. PCI or coronary artery bypass graft (CABG) within 6 months before enrollment;
  12. Target lesion is in-stent restenosis;
  13. Women in gestation period or lactation period or human chorionic gonadotropin (HCG) urine test positive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jailed-balloon technique
Apply jailed-balloon technique to protect the side branch during coronary bifurcation PCI
Procedure: Jailed-balloon technique
A monorail balloon is placed in the side branch(SB) before the stent in main branch(MB) is deployed. After MB stent is deployed to nominal pressure, the balloon in SB is inflated to 3 atm generally but to higher pressure to perform angioplasty if the blood flow in SB is compromised. The balloon in SB is then removed while the wire in SB is left in place. The MB stent balloon is inflated again for stent apposition. The SB wire is left in place to facilitate rewiring if the blood flow in SB is compromised. Otherwise the SB wire is removed after the stent balloon is inflated again.
Active Comparator: Jailed-wire technique
Apply jailed-wire technique to protect the side branch during coronary bifurcation PCI
Procedure: Jailed-wire technique
A percutaneous transluminal coronary angioplasty(PTCA) wire is placed in the side branch(SB) before the stent in main branch(MB) is deployed. After MB stent is deployed to some pressure to achieve full apposition, the wire in SB is left in place to facilitate rewiring if the blood flow in SB is compromised. Otherwise the SB wire is removed after the MB stent is deployed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side branch(SB) loss and PCI related myocardial infarction
Time Frame: Within 48 hours after PCI

The primary outcome of the study is a composite of SB loss or PCI related myocardial infarction.

According to Thrombolysis in Myocardial Infarction (TIMI) flow grading system, SB loss is defined as less than TIMI 3 flow immediately following MB stenting. It is considered temporary SB loss if TIMI 3 flow is restored with angioplasty and/or stenting. Otherwise, SB loss is considered permanent.

In patients with normal (≤99th percentile URL) baseline cardiac troponin(cTn) concentrations, PCI related myocardial infarction is defined as elevations of cTn >5× 99th percentile URL occurring within 48 hours of the procedure, which should be accompanied with other evidence of myocardial injury. A rise of >20% is required for the diagnosis of PCI related myocardial infarction if the baseline cTn values are elevated and are stable or falling.
Within 48 hours after PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events(MACEs)
Time Frame: Within 1 year after PCI
MACEs is a composite end point including cardiac death, non fatal myocardial infarction and target vessel revascularization(TVR).
Within 1 year after PCI
PCI related complication
Time Frame: Immediately after PCI
PCI related complication include coronary dissection, coronary perforation, device dislodgement, device entrapment and device rupture.
Immediately after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Collaborators

Shenzhen People's Hospital
Kashgar 1st People's Hospital

Investigators

  • Study Chair: Jiyan Chen, Doctor, Guangdong Provincial People's Hospital
  • Study Director: Jianfang Luo, Doctor, Guangdong Provincial People's Hospital
  • Principal Investigator: Pengcheng He, Doctor, Guangdong Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (Estimate)

June 19, 2014

Study Record Updates

Last Update Posted (Estimate)

June 19, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JBT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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