N/A
N=214
Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques
Stable Angina
Bottom Line
View on ClinicalTrials.gov: NCT02137486 ↗Enrolled (actual)
214
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Percentage of Participants With Major Adverse Cardiac Events(MACE) — 1.72; 6.86 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Taipei City Hospital
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Major Adverse Cardiac Events(MACE) |
1.72; 6.86 | — |
| PRIMARY Percentage of Participants With Cardiovascular Mortality(%) |
0; 1 | — |
| SECONDARY Percentage of Participants With Angiographic Success(%) |
90; 84 | — |
| SECONDARY Percentage of Participants With Target Vessel Revascularization Rate |
24; 19 | — |
| SECONDARY Fluoroscopy Time(Minutes) of Each Participants |
24; 36 | — |
| SECONDARY Procedure Time(Minutes) of Each Participants |
84; 92 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02137486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.