NCT03824600

Brief Summary

Registry of patients undergoing invasive fractional flow reserve measurement using a motorized device.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

January 27, 2019

Last Update Submit

March 27, 2020

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined)

    Describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease. A pullback device adapted to grip the coronary pressure wire with a speed of 1 mm/sec during continued pressure recording will be used. A fractional flow reserve value every 100 microns will be extracted from the pressure tracing and plotted against the length to generate a pullback curve. Fractional flow reserve will be defined as the ratio of the moving average of the proximal and distal coronary pressures. The patterns of physiological disease will be classified as focal or diffuse according to the visual inspection of the fractional flow reserve pullback curve. The patterns of coronary artery disease will be reported as a focal, diffuse or combined pattern (i.e. focal and diffuse).

    Immediate post-procedure. No follow-up is schedule for this trial.

Other Outcomes (1)

  • Classification of the physiological patterns of coronary artery disease using a quantitative metric

    Immediate post-procedure. No follow-up is schedule for this trial.

Interventions

Fractional Flow Reserve Motorized PullbackDIAGNOSTIC_TEST

A pullback device (Volcano R 100, San Diego CA, USA), adapted to grip the coronary pressure wire (PressureWire X, St Jude Medical, Minneapolis, USA), set at a speed of 1 mm/sec to pullback the pressure-wire until the tip of the guiding catheter during continued pressure recording.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing clinically indicated coronary angiography and fractional flow reserve evaluation for intermediate coronary lesions defined as visual diameter stenosis between 30% and 70%

You may qualify if:

  • Stable coronary artery disease

You may not qualify if:

  • acute coronary syndromes
  • previous coronary artery bypass grafting
  • significant valvular disease
  • severe obstructive pulmonary disease or asthma bronchial
  • severe tortuosity or severe calcification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OLV Aalst

Aalst, West Flanders, 9300, Belgium

Location

University of Brussels

Brussels, 1090, Belgium

Location

Related Publications (2)

  • Argacha JF, Decamp J, Vandeloo B, Babin D, Lochy S, Van den Bussche K, de Hemptinne Q, Xaplanteris P, Magne J, Segers P, Cosyns B. Guiding Myocardial Revascularization by Algorithmic Interpretation of FFR Pullback Curves: A Proof of Concept Study. Front Cardiovasc Med. 2021 Mar 11;8:623841. doi: 10.3389/fcvm.2021.623841. eCollection 2021.

    PMID: 33778020DERIVED

  • Collet C, Sonck J, Vandeloo B, Mizukami T, Roosens B, Lochy S, Argacha JF, Schoors D, Colaiori I, Di Gioia G, Kodeboina M, Suzuki H, Van 't Veer M, Bartunek J, Barbato E, Cosyns B, De Bruyne B. Measurement of Hyperemic Pullback Pressure Gradients to Characterize Patterns of Coronary Atherosclerosis. J Am Coll Cardiol. 2019 Oct 8;74(14):1772-1784. doi: 10.1016/j.jacc.2019.07.072.

    PMID: 31582137DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Bernard De Bruyne, MD, PhD

    OLV-Aalst

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director Catheterization Laboratory

Study Record Dates

First Submitted

January 27, 2019

First Posted

January 31, 2019

Study Start

November 24, 2017

Primary Completion

August 30, 2019

Study Completion

September 30, 2019

Last Updated

March 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)