Comparison Between Main Branch and Side Branch Vessels

NCT ID: NCT01046409

Last Updated: 2011-08-22

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

UNKNOWN

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this trial is

1. to compare the clinical significance of the main vessel and the side branch vessel using EKG, pain score and coronary wedge pressure
2. to develop a new scoring system to predict the clinical significance of a side branch

Detailed Description

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1. Clinical significance EKG change, pain score during 1 min balloon occlusion
2. Different characteristics between ST segment elevation vs non-elevation side branches
3. Comparison of coronary wedge pressure
4. Establishing a new scoring system to predict the ST elevation during 1min balloon occlusion

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Main vessel, side branch vessel

Measuring collateral flow

Intervention Type OTHER

Measuring collateral flow using pressure and/or velocity coronary wire

Interventions

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Measuring collateral flow

Measuring collateral flow using pressure and/or velocity coronary wire

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18
* Able to verbally confirm understandings of risks, benefits of receiving percutaneous coronary intervention (PCI) for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
* Significant stenosis at bifurcation lesion (\>50% by visual estimate) which always includes stenosis of side branch (true bifurcation)
* Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) in a native coronary artery with diameter of ≥ 2.25 mm
* Target lesion(s) amenable for PCI with final kissing balloon angioplasty for the side branch

Exclusion Criteria

* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
* Patients refuse to give informed consent
* Patients with left main coronary artery stenosis
* Patients with total occlusion of the bifurcation lesion
* Patients with infarct-related artery at the lesion of interest
* Patients with left ventricular ejection fraction\<40%
* Patients with primary cardiomyopathy
* Patients with chronic kidney disease defined as serum Cr\>2.0
* Patients who have severe side effects or contraindication to adenosine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bon-Kwon Koo

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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, Kang HJ, Youn TJ, Chae IH, Choi DJ, Kim HS, Sohn DW, Oh BH, Lee MM, Park YB, Choi YS, Tahk SJ. Physiologic assessment of jailed side branch lesions using fractional flow reserve. J Am Coll Cardiol. 2005 Aug 16;46(4):633-7. doi: 10.1016/j.jacc.2005.04.054.

Reference Type BACKGROUND
PMID: 16098427 (View on PubMed)

Pijls NH, van Son JA, Kirkeeide RL, De Bruyne B, Gould KL. Experimental basis of determining maximum coronary, myocardial, and collateral blood flow by pressure measurements for assessing functional stenosis severity before and after percutaneous transluminal coronary angioplasty. Circulation. 1993 Apr;87(4):1354-67. doi: 10.1161/01.cir.87.4.1354.

Reference Type BACKGROUND
PMID: 8462157 (View on PubMed)

Pijls NH, Bech GJ, el Gamal MI, Bonnier HJ, De Bruyne B, Van Gelder B, Michels HR, Koolen JJ. Quantification of recruitable coronary collateral blood flow in conscious humans and its potential to predict future ischemic events. J Am Coll Cardiol. 1995 Jun;25(7):1522-8. doi: 10.1016/0735-1097(95)00111-g.

Reference Type BACKGROUND
PMID: 7759702 (View on PubMed)

Billinger M, Kloos P, Eberli FR, Windecker S, Meier B, Seiler C. Physiologically assessed coronary collateral flow and adverse cardiac ischemic events: a follow-up study in 403 patients with coronary artery disease. J Am Coll Cardiol. 2002 Nov 6;40(9):1545-50. doi: 10.1016/s0735-1097(02)02378-1.

Reference Type BACKGROUND
PMID: 12427404 (View on PubMed)

Koo BK, Lee SP, Lee JH, Park KW, Suh JW, Cho YS, Chung WY, Doh JH, Nam CW, Yu CW, Lee BK, Vassilev D, Gil R, Lim HS, Tahk SJ, Kim HS. Assessment of clinical, electrocardiographic, and physiological relevance of diagonal branch in left anterior descending coronary artery bifurcation lesions. JACC Cardiovasc Interv. 2012 Nov;5(11):1126-32. doi: 10.1016/j.jcin.2012.05.018.

Reference Type DERIVED
PMID: 23174636 (View on PubMed)

Other Identifiers

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H-0910-003-062

Identifier Type: -

Identifier Source: org_study_id

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