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

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ClinicalTrials.gov Identifier: NCT02137486
Recruitment Status : Recruiting
First Posted : May 13, 2014
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Yueh-Chung, Chen, Taipei City Hospital

April 19, 2014
May 13, 2014
May 2, 2017
April 2015
June 2016   (Final data collection date for primary outcome measure)
  • 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.
MACE:major adverse cardiac event [ Time Frame: 12 months ]
MACE(major adverse cardiac event):a composite of death, MI(myocardial infarction), or repeat coronary revascularization of the target lesion).
Complete list of historical versions of study NCT02137486 on ClinicalTrials.gov Archive Site
  • 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.
target lesion revascularization(TLR) and restenosis rate. [ Time Frame: 12 months. ]
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Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques
Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques

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.

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Observational
Observational Model: Case-Control
Time Perspective: Retrospective
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Probability Sample
patients revceived coronary intervention between 2009-2014/3.
Stable Angina
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
214
57
October 2017
June 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 95 Years   (Adult, Older Adult)
No
Contact: Chen Yueh Chung, chief doctor 886227093600 ext 3741 chenyuehchung.tw@yahoo.com.tw
Taiwan
 
 
NCT02137486
TCHIRB-1030209-E
No
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Yueh-Chung, Chen, Taipei City Hospital
Taipei City Hospital
Not Provided
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Taipei City Hospital
April 2017