Clincosm LogoSign in Get a demo

Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease

Sponsor
CathWorks Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03455244
Collaborator
(none)
50
Enrollment
1
Location
5.6
Actual Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

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 diagnosing hemodynamically significant coronary stenosis in Multi-Vessel Disease.

Condition or Disease Intervention/Treatment Phase
  • Device: FFRangio

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease
Actual Study Start Date :
Nov 14, 2017
Actual Primary Completion Date :
May 2, 2018
Actual Study Completion Date :
May 2, 2018

Outcome Measures

Primary Outcome Measures

  1. Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR [1 hour]

    Sensitivity and specificity of the dichotomously scored FFRangio measured index per vessel as compared with invasively-derived FFR; Index ≤ 0.80 is scored "positive" while Index > 0.8 is negative.

Secondary Outcome Measures

  1. Continuously scored FFR (FFRangio and Invasive FFR). [1 hour]

    Regression of FFRangio on continuous FFR, with slope, intercept and the correlation coefficient.

  2. Accuracy, Positive predictive value and negative predictive value per vessel and per lesion [1 hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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 Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gifu Heart Center Gifu Japan 500-8384

Sponsors and Collaborators

  • CathWorks Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CathWorks Ltd.
ClinicalTrials.gov Identifier:
NCT03455244
Other Study ID Numbers:
  • CWX-04
First Posted:
Mar 6, 2018
Last Update Posted:
Jun 25, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Coronary Artery Disease

Study Results

No Results Posted as of Jun 25, 2018