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

This study is currently recruiting participants.
Verified April 2017 by Yueh-Chung, Chen, Taipei City Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02137486
First Posted: May 13, 2014
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yueh-Chung, Chen, Taipei City Hospital
  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.

We introduced a retrospective analysis for high angulated bifurcation lesions with intermediate to high complexity(SYNTAX>22) treated with either DES or BMS.

Primary endpoint: cardiovascular mortality, TLR, MACE. secondary endpoint: procedure time, fluoroscopy time, procedure success, angiographic success.


Condition
Stable Angina

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 Yueh-Chung, Chen, Taipei City Hospital:

Primary Outcome Measures:
  • MACE(%) [ Time Frame: 24 months ]
    as medical chart record.

  • PRU [ Time Frame: 24 months ]
    as medical chart record.

  • cardiovascular mortality(%) [ Time Frame: 24 months ]
    as medical chart record.


Secondary Outcome Measures:
  • angiographic success(%) [ Time Frame: 24 months. ]
    as medical chart record.

  • target vessel revascularization rate(%) [ Time Frame: 24 months. ]
    as medical chart record.

  • fluoroscopy time(minutes) [ Time Frame: 24 months. ]
    as medical chart record.

  • procedure time(minutes) [ Time Frame: 24 months. ]
    as medical chart record.


Estimated Enrollment: 214
Study Start Date: April 2015
Estimated Study Completion Date: October 2017
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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. SYNTAX>22 Procedure success. de novo lesion

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 19, 2014
First Posted: May 13, 2014
Last Update Posted: November 13, 2017
Last Verified: April 2017

Keywords provided by Yueh-Chung, Chen, Taipei City Hospital:
stable angina
high angulated bifurcation
SYNTAX
DES
BMS

Additional relevant MeSH terms:
Angina, Stable
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms