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Jailed-balloon Technique in Coronary Bifurcation Lesion PCI

NCT02167230 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2014-06-19

No results posted yet for this study

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).

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Shenzhen People's Hospital

    collaborator OTHER

  • Kashgar 1st People's Hospital

    collaborator OTHER

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Jiyan Chen, Doctor · Guangdong Provincial People's Hospital

  • Jianfang Luo, Doctor · Guangdong Provincial People's Hospital

  • Pengcheng He, Doctor · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-09-30
Completion
2017-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02167230 on ClinicalTrials.gov