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).

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

410

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline

Completed

Started Oct 2014

Typical duration for not_applicable coronary-artery-disease

Geographic Reach

1 country

2 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

First Submitted

Initial submission to the registry

June 17, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed

3 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed

Last Updated

June 19, 2014

Status Verified

June 1, 2014

Enrollment Period

1.9 years

First QC Date

June 17, 2014

Last Update Submit

June 17, 2014

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseasePercutaneous Coronary InterventionBifurcationJailed-balloon technique

Outcome Measures

Primary Outcomes (1)

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.
Within 48 hours after PCI

Secondary Outcomes (2)

Major adverse cardiovascular events(MACEs)
Within 1 year after PCI
PCI related complication
Immediately after PCI

Study Arms (2)

Jailed-balloon technique

EXPERIMENTAL

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

Procedure: Jailed-balloon technique

Jailed-wire technique

ACTIVE COMPARATOR

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

Procedure: Jailed-wire technique

Interventions

Jailed-balloon techniquePROCEDURE

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.

Jailed-balloon technique

Jailed-wire techniquePROCEDURE

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.

Jailed-wire technique

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Guangdong Provincial People's Hospitallead
Shenzhen People's Hospitalcollaborator
Kashgar 1st People's Hospitalcollaborator

Study Sites (2)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

Kashgar District 1st People's Hospital

Kashgar, Xinjiang, 844000, China

Location

Related Publications (5)

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.
PMID: 19962049BACKGROUND
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.
PMID: 19463303BACKGROUND
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.
PMID: 23420654BACKGROUND
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.
PMID: 20058502BACKGROUND
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.
PMID: 22364484BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

Jiyan Chen, Doctor
Guangdong Provincial People's Hospital
STUDY CHAIR
Jianfang Luo, Doctor
Guangdong Provincial People's Hospital
STUDY DIRECTOR
Pengcheng He, Doctor
Guangdong Provincial People's Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengcheng He, Doctor

CONTACT

86-20-83827812 he_peng_cheng@aliyun.com

Jianfang Luo, Doctor

CONTACT

86-20-83827812 henyjfl@tom.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 19, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

June 19, 2014

Record last verified: 2014-06

Locations

CN(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Jailed-balloon technique

Jailed-wire technique

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations