N/A Completed N=39 Diagnostic

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

Cardiovascular Disease

Source: ClinicalTrials.gov NCT04098172 ↗

Enrolled (actual)

Serious AEs

2.6%

Results posted

Jun 2021

Primary outcomePrimary: Fractional Flow Reserve (FFR) — 0.862; 0.863 Ratio

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Fractional Flow Reserve (FFR)	0.862; 0.863	—

Eligibility Criteria

General Inclusion Criteria:

Patient must be at least 18 years old and less than or equal to 75 years of age
Patient or his/her legally-authorized representative agrees to sign the EC-approved ICF prior to the procedure
Patient with stable angina or any form of non-ST elevation acute coronary syndrome and is clinically indicated of intra-coronary diagnostic angiography and FFR assessment

Angiographic Inclusion Criteria:

Moderate stenosis (30% to 70% diameter stenosis by visual estimation) is detected at diagnostic angiography

General Exclusion Criteria:

Patients unable to provide informed consent
Patients in pregnant state
Known renal insufficiency or failure (serum creatinine level of > 2.5 mg/dL, or on dialysis)
Allergy to the contrast
Significant arrhythmia, such as II degree or above of atrioventricular block, Sick sinus syndrome, ventricular tachycardia
Spastic bronchial asthma
ST elevation coronary syndrome
Hemodynamic instability
Contraindication to nitroglycerin or ATP
Current participation in another investigational drug or device clinical study that may affect the FFR measurements

Angiographic Exclusion Criteria:

CTO lesion Severe vessel tortuosity at the stenotic segments Culprit vessel of non-ST-segment elevation acute myocardial infarction

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04098172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.