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

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Jailed-balloon technique

Jailed-wire technique

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Percutaneous Coronary Intervention, Bifurcation, Jailed-balloon technique

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18 years and ≤75 years;
De novo Medina 1,1,1 coronary bifurcation with a main branch(MB) >2.5mm while side branch <2.5mm and >1.5mm;
Only one bifurcation lesion need to be treated in one vessel;
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%;
Signed consent is obtained.

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Jailed-balloon technique

Jailed-wire technique

Arm Description

Apply jailed-balloon technique to protect the side branch during coronary bifurcation PCI

Apply jailed-wire technique to protect the side branch during coronary bifurcation PCI

Outcomes

Primary Outcome Measures

Side branch(SB) loss and PCI related myocardial infarction

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.

Secondary Outcome Measures

Major adverse cardiovascular events(MACEs)

MACEs is a composite end point including cardiac death, non fatal myocardial infarction and target vessel revascularization(TVR).

PCI related complication

PCI related complication include coronary dissection, coronary perforation, device dislodgement, device entrapment and device rupture.

Full Information

NCT ID

NCT02167230

First Posted

June 17, 2014

Last Updated

June 17, 2014

Sponsor

Guangdong Provincial People's Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02167230

Brief Title

Jailed-balloon Technique in Coronary Bifurcation Lesion PCI

Acronym

JBTinCBL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guangdong Provincial People's Hospital

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

Detailed Description

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

6. Conditions and Keywords

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

Coronary Artery Disease

Keywords

Coronary Artery Disease, Percutaneous Coronary Intervention, Bifurcation, Jailed-balloon technique

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Jailed-balloon technique

Arm Type

Experimental

Arm Description

Apply jailed-balloon technique to protect the side branch during coronary bifurcation PCI

Arm Title

Jailed-wire technique

Arm Type

Active Comparator

Arm Description

Apply jailed-wire technique to protect the side branch during coronary bifurcation PCI

Intervention Type

Procedure

Intervention Name(s)

Jailed-balloon technique

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Jailed-wire technique

Intervention Description

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.

Primary Outcome Measure Information:

Title

Side branch(SB) loss and PCI related myocardial infarction

Description

Time Frame

Within 48 hours after PCI

Secondary Outcome Measure Information:

Title

Major adverse cardiovascular events(MACEs)

Description

MACEs is a composite end point including cardiac death, non fatal myocardial infarction and target vessel revascularization(TVR).

Time Frame

Within 1 year after PCI

Title

PCI related complication

Description

PCI related complication include coronary dissection, coronary perforation, device dislodgement, device entrapment and device rupture.

Time Frame

Immediately after PCI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 years and ≤75 years; De novo Medina 1,1,1 coronary bifurcation with a main branch(MB) >2.5mm while side branch <2.5mm and >1.5mm; Only one bifurcation lesion need to be treated in one vessel; 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%; Signed consent is obtained. Exclusion Criteria: Left ventricular ejection fraction(LVEF) less than 30%; Hemodynamic instability or cardiac shock; Myopathy or muscular injury with elevation of creatine kinase to more than 3mg/dL; Tumor with expected survival less than 1 year; Autoimmune disease; Active gastrointestinal bleeding or any contraindication for dual antiplatelet therapy; Acute coronary syndrome require emergency PCI; Coronary bifurcation need to be treated with two-stent strategy; Not suitable for drug-eluting stent(DES) implantation; Mental disorder or alcohol dependence; PCI or coronary artery bypass graft (CABG) within 6 months before enrollment; Target lesion is in-stent restenosis; Women in gestation period or lactation period or human chorionic gonadotropin (HCG) urine test positive.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pengcheng He, Doctor

Phone

86-20-83827812

Ext

10580

he_peng_cheng@aliyun.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jianfang Luo, Doctor

Phone

86-20-83827812

Ext

11300

henyjfl@tom.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiyan Chen, Doctor

Organizational Affiliation

Guangdong Provincial People's Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jianfang Luo, Doctor

Organizational Affiliation

Guangdong Provincial People's Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Pengcheng He, Doctor

Organizational Affiliation

Guangdong Provincial People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shenzhen People's Hospital

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518020

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shaohong Dong, Doctor

Phone

86-755-25533018

Ext

3221

dsh266@medmail.com

First Name & Middle Initial & Last Name & Degree

Huadong Liu, Doctor

Phone

86-755-25533018

Ext

3202

lhd2578@163.com

First Name & Middle Initial & Last Name & Degree

Shaohong Dong, Master

Facility Name

Kashgar District 1st People's Hospital

City

Kashgar

State/Province

Xinjiang

ZIP/Postal Code

844000

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heyin Yang, Bachelor

Phone

86-998-2565206

13579068456@163.com

First Name & Middle Initial & Last Name & Degree

Yuying Hu, Bachelor

Phone

86-998-2565208

huyuyingks@163.com

First Name & Middle Initial & Last Name & Degree

Heyin Yang, Bachelor

12. IPD Sharing Statement

Citations:

PubMed Identifier

19962049

Citation

Sharma SK, Sweeny J, Kini AS. Coronary bifurcation lesions: a current update. Cardiol Clin. 2010 Feb;28(1):55-70. doi: 10.1016/j.ccl.2009.10.001.

Results Reference

background

PubMed Identifier

19463303

Citation

Latib A, Colombo A. Bifurcation disease: what do we know, what should we do? JACC Cardiovasc Interv. 2008 Jun;1(3):218-26. doi: 10.1016/j.jcin.2007.12.008.

Results Reference

background

PubMed Identifier

23420654

Citation

Depta JP, Patel Y, Patel JS, Novak E, Yeung M, Zajarias A, Kurz HI, Lasala JM, Bach RG, Singh J. Long-term clinical outcomes with the use of a modified provisional jailed-balloon stenting technique for the treatment of nonleft main coronary bifurcation lesions. Catheter Cardiovasc Interv. 2013 Nov 1;82(5):E637-46. doi: 10.1002/ccd.24778. Epub 2013 Jul 30.

Results Reference

background

PubMed Identifier

20058502

Citation

Colombo F, Biondi-Zoccai G, Infantino V, Omede P, Moretti C, Sciuto F, Siliquini R, Chiado S, Trevi GP, Sheiban I. A long-term comparison of drug-eluting versus bare metal stents for the percutaneous treatment of coronary bifurcation lesions. Acta Cardiol. 2009 Oct;64(5):583-8. doi: 10.2143/AC.64.5.2042686.

Results Reference

background

PubMed Identifier

22364484

Citation

Singh J, Patel Y, Depta JP, Mathews SJ, Cyrus T, Zajarias A, Kurz HI, Lasala JM, Bach RG. A modified provisional stenting approach to coronary bifurcation lesions: clinical application of the "jailed-balloon technique". J Interv Cardiol. 2012 Jun;25(3):289-96. doi: 10.1111/j.1540-8183.2011.00716.x. Epub 2012 Feb 26.

Results Reference

background

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