Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques

Stable Angina Clinical Trial

— MV:main branch  

Official title:

Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137486
• Other study ID #: TCHIRB-1030209-E
• Status: Completed
• Start date: April 1, 2015
• Est. completion date: November 1, 2017

Study information

• Verified date: April 2017
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: November 1, 2017
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina, Stable
• Stable Angina

Locations

Country	Name	City	State
Taiwan	Taipei city hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Major Adverse Cardiac Events(MACE)	Percentage of Participants with major adverse cardiac events(MACE) was defined as rates of target lesion revascularization (TLR) and restenosis during first post-treatment year, and rates of acute, subacute, and late in-stent thrombosis, periprocedure MI(myocardial infarction).	periprocedure up to 12 months
Primary	Percentage of Participants With Cardiovascular Mortality(%)	Percentage of Participants with cardiovascular mortality was defined as death related to cardiovascular causes within 2 years.	periprocedure up to 12 months
Secondary	Percentage of Participants With Angiographic Success(%)	Percentage of Participants with angiographic success was defined as residual stenosis<50% under fluoroscopy at the end of procedure.	periprocedure up to 12 months.
Secondary	Percentage of Participants With Target Vessel Revascularization Rate	Percentage of Participants with target vessel revascularization rate, both arms	periprocedure up to 12 months.
Secondary	Fluoroscopy Time(Minutes) of Each Participants	as medical chart record.	periprocedure up to 12 months.
Secondary	Procedure Time(Minutes) of Each Participants	as medical chart record.	periprocedure up to 12 months.