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

NCT02137486 | Completed Results

• 1 other identifier: TCHIRB-1030209-E
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina

Keywords

stable angina; high angulated bifurcation; SYNTAX; DES; BMS

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Percentage of Participants With Angiographic Success(%)

  periprocedure up to 12 months.

• Percentage of Participants With Target Vessel Revascularization Rate

  periprocedure up to 12 months.

• Fluoroscopy Time(Minutes) of Each Participants

  periprocedure up to 12 months.

• Procedure Time(Minutes) of Each Participants

  periprocedure up to 12 months.

Study Arms (2)

sequential ballooning

include BMS or DES

final kissing ballooning

include BMS or DES

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients revceived coronary intervention between 2009-2014/3.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Taipei city hospital

Taipei, 52005, Taiwan

Location

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: taipei city hospital Ren-Ai branch
• Organization: cardiovascular section

chenyuehchung.tw@yahoo.com.tw

0088627093600

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of ICU

Study Record Dates

• First Submitted: April 19, 2014
• First Posted: May 13, 2014
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2017
• Last Updated: October 4, 2019
• Results First Posted: October 4, 2019

Record last verified: 2017-04

Locations

TW (1)