Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques (MV:main branch)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Taipei City Hospital
Sponsor:
Information provided by (Responsible Party):
Yueh-Chung, Chen, Taipei City Hospital
ClinicalTrials.gov Identifier:
NCT02137486
First received: April 19, 2014
Last updated: July 1, 2014
Last verified: April 2014
  Purpose

Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis. Their structural properties make angioplasty technique to increase the difficulty of implementation, but also increased the risks of the in-stent thrombosis and restenosis. Standard treatment of coronary bifurcation lesions remains controversial manner, especially when the side branch (SB) was large combined with high angulated bifurcation lesions. Complex procedures and certain types of lesions are associated with poor prognosis. There is no standard treatment for such lesions even with the development of drug-eluting stents solve partial problems. The investigators reviewed patients who received coronary intervention between 2009-2012 years and met the inclusion criteria, and then analyzed the prognostic relevance of these cases the use of different treatment modalities .


Condition
High Angle, Bifurcation, Coronary Intervention.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques

Further study details as provided by Taipei City Hospital:

Primary Outcome Measures:
  • MACE:major adverse cardiac event [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    MACE(major adverse cardiac event):a composite of death, MI(myocardial infarction), or repeat coronary revascularization of the target lesion).


Secondary Outcome Measures:
  • target lesion revascularization(TLR) and restenosis rate. [ Time Frame: 12 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 57
Study Start Date: April 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients revceived coronary intervention between 2009-2014/3.

Criteria

Inclusion Criteria:

  • Angulated bifurcation:MV(main branch) and SB(side branch) angle>70 degree. MV diameter≥2.5mm and eligible for stenting. lesion stenotic severity>70% by QCA(Quantitative coronary analysis). 1 stent strategy. Procedure success.

Exclusion Criteria:

  • Bifurcation lesions intervention without side br. ballooning after stents deployment or procedure incomplete. Left main coronary artery bifurcational lesions. Elective,provisional or bail-out stenting for side br.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02137486

Contacts
Contact: Chen Yueh Chung, chief doctor 886227093600 ext 3741 chenyuehchung.tw@yahoo.com.tw

Locations
Taiwan
Taipei city hospital Recruiting
Taipei, Taiwan, 52005
Contact: Chen Yueh Chung    886227093600 ext 3741    chenyuehchung.tw@yahoo.com.tw   
Sponsors and Collaborators
Taipei City Hospital
  More Information

No publications provided

Responsible Party: Yueh-Chung, Chen, chief of ICU, Taipei City Hospital
ClinicalTrials.gov Identifier: NCT02137486     History of Changes
Other Study ID Numbers: TCHIRB-1030209-E
Study First Received: April 19, 2014
Last Updated: July 1, 2014
Health Authority: Taiwan: Ministry of Health and Welfare

ClinicalTrials.gov processed this record on September 16, 2014