FFR vs. icECG in Coronary Bifurcations

Status unconfirmed

Conditions studied: Coronary Artery Disease

In brief

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 lesions.

Key facts

Study ID

NCT01724957

Run by

University National Heart Hospital

People needed

37

Starts

2012-09-01

Expected to finish

2020-12-01

Last updated by the study team

2019-08-20

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• National Heart Hospital — Sofia, Bulgaria (enrolling)
• Indiana-Purdue University — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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