Trials / Completed
CompletedNCT04098172
Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR
A Prospective, Multicenter Study to Evaluate the Performance and Safety of CometTM Pressure Guidewire in the Measurement of FFR in Chinese Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements
Detailed description
The COMET China study is a prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements. Patient with stable angina or any form of non-ST elevation acute coronary syndrome, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pressure Guidewire | Fractional Flow Reserve measurement |
Timeline
- Start date
- 2019-09-03
- Primary completion
- 2020-03-11
- Completion
- 2020-03-11
- First posted
- 2019-09-23
- Last updated
- 2021-11-01
- Results posted
- 2021-06-07
Locations
2 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04098172. Inclusion in this directory is not an endorsement.