Comparison Between Main Branch and Side Branch Vessels

Coronary Artery Disease Clinical Trial

Official title:

Comparison of Clinical, Electrical and Physiologic Significance Between Main Branch and Side Branch Vessels

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01046409
• Other study ID #: H-0910-003-062
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

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