Coronary Artery Disease Clinical Trial
Official title:
Comparison of Clinical, Electrical and Physiologic Significance Between Main Branch and Side Branch Vessels
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 |
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
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 |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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
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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