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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01046409
Other study ID # H-0910-003-062
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 8, 2010
Last updated August 18, 2011
Start date January 2010
Est. completion date December 2011

Study information

Verified date August 2011
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry for Health and Welfare
Study type Observational

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 51
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Intervention

Other:
Measuring collateral flow
Measuring collateral flow using pressure and/or velocity coronary wire

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary ST elevation during 1min balloon occlusion Day 1 after PCI No
Secondary Pain score during 1min balloon occlusion Day 1 after PCI No
Secondary coronary wedge pressure during the procedure No
Secondary Usefulness of new scoring system New scoring system includes the vessel size, myocardial territory and relationship with neighboring branches During the procedure No
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