The study hypothesis: it is possible to use icECG recorded from regular PCI wire to predict
significance of SB ostial stenosis after main vessel stenting in coronary bifurcation
Procedure: Intracoronary ECG
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01724957
Ages eligible for Study
18 Years to 90 Years
Genders eligible for Study
Accepts Healthy Volunteers
Subject at least 18 years of age.
Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
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) located in a native coronary artery with diameter of ≥ 2.0 mm.
Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.
Subjects with significant ST-T change (≥ 1mm).
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).
Subjects who refuse to give informed consent.
Subjects with the following angiographic characteristics: left main coronary artery stenosis, total occlusion before occurrence of SB, lesion of interest located at infarct-related artery.
Subjects with LVEF < 30%.
Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy.
LBBB, RBBB, atrial fibrillation/flutter with no identifiable isoelectric line.
All locations for NCT01724957
United States (1)
Indianapolis, Indiana, United States, IN 46202
active not recruiting
National Heart Hospital
Sofia, Bulgaria, 1309
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View full eligibility
Tris trial is registered with FDA with number: NCT01724957. The sponsor of the trial is University National Heart Hospital and it is looking for 37 volunteers for the current phase.
Official trial title: Fractional Flow Reserve Versus Intracoronary ECG for Detection of Post Stenting Ischemia in Side Branch Territory in coronAry Bifurcation Lesions
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