NCT04098172

Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR

Completed NA Results posted Last updated 1 November 2021

What this trial tests

NA trial testing Pressure Guidewire in Cardiovascular Diseases in 39 participants. Completed in 11 March 2020.

Timeline

3 September 2019

Primary endpoint
11 March 2020

11 March 2020

Quick facts

Lead sponsor	Boston Scientific Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	39
Start date	3 September 2019
Primary completion	11 March 2020
Estimated completion	11 March 2020
Sites	2 locations across China

Drugs / interventions tested

• Pressure Guidewire

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

Adults 18 to 75, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fractional Flow Reserve (FFR) Primary · during procedure, 1 hour

All eligible subjects will receive FFR measurements simultaneously by both CometTM Pressure Guidewire and Pressure wires Certus®. Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR lower than 0.75-0.80 is generally considered to be associated with myocardial ischemia (MI). Agreement between the method of measurement will be confirmed if both conditions are met: The mean paired difference

Group	Value	95% CI
Comet Pressure Guidewire Test Subject	0.862	0.841 – 0.883
Certus Pressure Guidewire Test Subject	0.863	0.842 – 0.884

Adverse events — posted to ClinicalTrials.gov

Time frame: The adverse event data were collected from subject procedure to subjects were discharged from hospital in 1 week.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pressure Guidewire Test Subject

Serious: 1/39 (3%)

Deaths: 1/39

Serious adverse events (1 terms)

Reaction	System	Pressure Guidewire Test Su…
Subclavian artery stenosis	Vascular disorders	—

Most-reported serious reactions: Subclavian artery stenosis.

Data from ClinicalTrials.gov NCT04098172 adverse events section.

Sponsor's own description

A prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.