Clinical trial NCT02137486: Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques
Official title: Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stable Angina
Keywords: stable angina
high angulated bifurcation
SYNTAX
DES
BMS
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2014-05-13
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients revceived coronary intervention between 2009-2014/3.

Brief summary: 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 treated with either DES or BMS.

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


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Major Adverse Cardiac Events(MACE)
timeFrame: periprocedure up to 12 months
measure: Percentage of Participants With Cardiovascular Mortality(%)
timeFrame: periprocedure up to 12 months
Secondary outcomes:
measure: Percentage of Participants With Angiographic Success(%)
timeFrame: periprocedure up to 12 months.
measure: Percentage of Participants With Target Vessel Revascularization Rate
timeFrame: periprocedure up to 12 months.
measure: Fluoroscopy Time(Minutes) of Each Participants
timeFrame: periprocedure up to 12 months.
measure: Procedure Time(Minutes) of Each Participants
timeFrame: periprocedure up to 12 months.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei city hospital
Study officials:
References: