Mechanism and Predictor of Side Branch Jailing

NCT ID: NCT00553670

Last Updated: 2011-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-05-31

Brief Summary

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Coronary artery bifurcation lesion is still one of the most challenging lesion subsets in the field of non-surgical treatment for a stenotic coronary artery. When one stent is placed in the main brach, it increases the side branch's stenosis degree. However, its mechanism and incidence are not known. This study will be performed to search for the mechanism and incidence of that phenomenon.

Detailed Description

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Conditions

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Bifurcating Coronary Artery Lesions Main Branch Stent Implantation Side Branch Jailing

Keywords

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coronary artery bifurcation stent intravascular ultrasound fractional flow reserve

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with elective coronary intervention for LAD-diagonal bifurcation lesion with provisional side branch intervention strategy with successful intravascular ultrasound and fractional flow reserve measurement

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Elective coronary intervention (including stabilized ACS patients)
2. Bifurcation lesion with TIMI 3 flow
3. Side branch diameter \> 2mm, side branch lesion length \< 10mm by visual estimation

Exclusion Criteria

1. Left main coronary disease
2. AMI, or Old MI at LAD territory
3. LVEF \< 40%, or other significant valvular or myocardial disease
4. Significant side branch distal lesion
5. Angiographically visible thrombus
6. Heavily calcified lesion
7. Side branch predilatation before main branch stent implantation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Bon-Kwon Koo, PhD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul national university hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Koo BK, Waseda K, Kang HJ, Kim HS, Nam CW, Hur SH, Kim JS, Choi D, Jang Y, Hahn JY, Gwon HC, Yoon MH, Tahk SJ, Chung WY, Cho YS, Choi DJ, Hasegawa T, Kataoka T, Oh SJ, Honda Y, Fitzgerald PJ, Fearon WF. Anatomic and functional evaluation of bifurcation lesions undergoing percutaneous coronary intervention. Circ Cardiovasc Interv. 2010 Apr;3(2):113-9. doi: 10.1161/CIRCINTERVENTIONS.109.887406.

Reference Type DERIVED
PMID: 20407111 (View on PubMed)

Other Identifiers

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H-0707-022-212

Identifier Type: -

Identifier Source: org_study_id