Status:
COMPLETED
Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease
Lead Sponsor:
CathWorks Ltd.
Conditions:
Multi Vessel Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, observational, single-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diag...
Eligibility Criteria
Inclusion
- \>18 years of age.
- Patients with stable angina or unstable angina or NSTEMI, with at least 1 stenoses ≥ 50% in two main vessels (LAD, LCX and/or RCA) each and in whom invasive FFR is being assessed at these stenoses.
- Patients undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.
- Written, informed consent.
Exclusion
- Contraindication for FFR examination or administration of vasodilators.
- Clinical presentation of an acute infarct (STEMI) or presented with STEMI in past year.
- CTO in a target vessel.
- Prior CABG, valvular surgery, TAVI/TAVR, or heart transplantation.
- Known LVEF ≤45%.
- Arteries supplying akinetic or severe hypokinetic territories if already known based on prior imaging.
- TIMI Grade 2 or lower at baseline.
- Target lesions involve Left Main (stenosis ≥50%.)
- In-stent restenosis in a target vessel.
- Heavily diffused atherosclerosis diseases defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
- Target coronary vessels are supplied by major collaterals.
- Lesion is in ectatic segment which includes dilatation in diameter at least 1.5 times that of the adjacent normal coronary artery.
- Coronary angiograms not acquired per instructions as defined in the Study Protocol.
Key Trial Info
Start Date :
November 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 2 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03455244
Start Date
November 14 2017
End Date
May 2 2018
Last Update
June 25 2018
Active Locations (1)
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1
Gifu Heart Center
Gifu, Japan, 500-8384