Comparison Between Main Branch and Side Branch Vessels

NCT01046409 | Unknown

• 1 other identifier: H-0910-003-062
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is

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

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Bifurcation; Myocardial infarction; Myocardial ischemia; Collateral

Outcome Measures

Primary Outcomes (1)

• ST elevation during 1min balloon occlusion

  Day 1 after PCI

Secondary Outcomes (3)

• Pain score during 1min balloon occlusion

  Day 1 after PCI

• coronary wedge pressure

  during the procedure

• Usefulness of new scoring system

  During the procedure

Study Arms (1)

Main vessel, side branch vessel

Other: Measuring collateral flow

Interventions

Measuring collateral flow OTHER

Measuring collateral flow using pressure and/or velocity coronary wire

Main vessel, side branch vessel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with significant coronary artery disease, involving the bifurcation lesions

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (5)

• 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.

  PMID: 16098427 BACKGROUND

• 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.

  PMID: 8462157 BACKGROUND

• 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.

  PMID: 7759702 BACKGROUND

• 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.

  PMID: 12427404 BACKGROUND

• 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.

  PMID: 23174636 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 12, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 22, 2011

Record last verified: 2011-08

Locations

KR (1)