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OpenTrials
Completed

NCT Number: NCT02137486

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 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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Key information

Conditions

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

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei city hospital

Taipei, 52005, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants With Major Adverse Cardiac Events(MACE)

    Time frame: periprocedure up to 12 months

    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).

  2. Percentage of Participants With Cardiovascular Mortality(%)

    Time frame: periprocedure up to 12 months

    Percentage of Participants with cardiovascular mortality was defined as death related to cardiovascular causes within 2 years.

Secondary outcomes

  1. Percentage of Participants With Angiographic Success(%)

    Time frame: periprocedure up to 12 months.

    Percentage of Participants with angiographic success was defined as residual stenosis<50% under fluoroscopy at the end of procedure.

  2. Percentage of Participants With Target Vessel Revascularization Rate

    Time frame: periprocedure up to 12 months.

    Percentage of Participants with target vessel revascularization rate, both arms

  3. Fluoroscopy Time(Minutes) of Each Participants

    Time frame: periprocedure up to 12 months.

    as medical chart record.

  4. Procedure Time(Minutes) of Each Participants

    Time frame: periprocedure up to 12 months.

    as medical chart record.

Sponsors and collaborators

Lead sponsor

Taipei City Hospital

Other Gov

Registry information

Acronym: MV:main branch

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 13, 2014
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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