NCT03541577

Brief Summary

TruePhysioTM Sensor-equipped Ultrathin Pressure Microcatheter (referred to as TruePhysioTM Microcatheter below) is a novel device for evaluating the functional significance of coronary stenosis. This study will compare the differences, if any, between the coronary fractional flow reserve (FFR) measured by the TruePhysioTM Microcatheter and the Pressure Wire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

May 17, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

June 19, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

May 17, 2018

Last Update Submit

May 23, 2022

Conditions

Coronary Artery DiseaseCoronary DiseaseMyocardial Ischemia

Outcome Measures

Primary Outcomes (1)

  • FFR Measurements

    Comparisons between the FFR measured by the TruePhysioTM Microcatheter and the Pressure Wire (PW), including bias, as assessed by Bland-Altman analysis.

    Duration of FFR measurement

Secondary Outcomes (10)

  • Pearson analysis

    Duration of FFR measurement

  • Slope of Passing-Bablok fit

    Duration of FFR measurement

  • Intercept of Passing-Bablok fit

    Duration of FFR measurement

  • Diagnostic FFR concurrence of functionally significant stenosis

    Duration of FFR measurement

  • Sensitivity, Specificity of TruePhysioTM Microcatheter in determining functionally significant stenosis

    Duration of FFR measurement

  • +5 more secondary outcomes

Study Arms (1)

Participants

Subjects who meet the inclusion criteria and do not meet the exclusion criteria and undergo FFR measurement with the TruePhysioTM Microcatheter and the Pressure Wire

Device: TruePhysioTM MicrocatheterDevice: Pressure Wire

Interventions

TruePhysioTM MicrocatheterDEVICE

Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR).

Also known as: FFR Microcatheter
Participants
Pressure WireDEVICE

Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR).

Also known as: PressureWire
Participants

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary artery disease for whom FFR measurement is thought to be clinically indicated.

You may qualify if:

  • Age: 18-75 years old
  • Subjects with coronary artery disease
  • Able to understand and provide signed consent
  • Subject has an intermediate stenosis in a native coronary vessel
  • The target stenosis has a reference diameter ≥2.50 mm by visual assessment.

You may not qualify if:

  • Acute ST-elevation or non-ST-elevation myocardial infarction
  • Severe heart failure (NYHA≥IV)
  • Left ventricular ejection fraction \<30%
  • Allergy to adenosine triphosphate (ATP)
  • Contraindications for percutaneous coronary intervention (PCI)
  • Target vessel has angiographically visible or suspected thrombus
  • Angiographic evidence of a dissection
  • Excessive tortuosity or calcification stenosis, left main stenosis, serial stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Guangdong General Hospital

Guangzhou, China

Location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China

Location

Shanghai Zhongshan Hospital

Shanghai, China

Location

Shenzhen People's Hospital

Shenzhen, China

Location

Related Publications (1)

  • Li C, Yang J, Dong S, Dong L, Chen J, Shen L, Zhang F, Li C, Liu H, Hu X, Hau WK, Qian J, Jeremias A, Wang J, Ge J; SUPREME Study Investigators. Multicenter clinical evaluation of a piezoresistive-MEMS-sensor rapid-exchange pressure microcatheter system for fractional flow reserve measurement. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):E243-E253. doi: 10.1002/ccd.29678. Epub 2021 May 5.

    PMID: 33951285RESULT

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2018

First Posted

May 30, 2018

Study Start

June 19, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)