Trials / Completed
CompletedNCT04582877
Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Zurich Medical Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Patients with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System). Both articles are used within the same participant and the FFR values are statistically compared with each other.
Detailed description
The objective of the 'Pressure guidewire system multi-center, prospective, single-subject design clinical trial' is to evaluate the effectiveness and safety of Zurich Medical's pressure guidewire system (including guidewire with high-fidelity sensors and a unique paired portable display unit), which is used to measure the coronary artery blood fractional flow reserve (FFR) to diagnose coronary artery disease, and to direct a catheter through a blood vessel. This clinical trial uses a multi-center, prospective, single-subject design trial method, using St. Jude Medical's pressure guidewire and Analyzer Express as a control device. The subjects who met the criteria for this study will be registered with the central registration system after enrollment. Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System). Both articles are used within the same participant and the FFR values are statistically compared with each other. The subject's FFR of coronary artery stenosis will first be measured using investigational device and recorded, and then measured using control device and recorded. The safety follow-up period is 48 hours.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FFR measurement | FFR is measured sequentially with the test article and the predicate device. |
Timeline
- Start date
- 2020-09-23
- Primary completion
- 2023-11-15
- Completion
- 2024-04-30
- First posted
- 2020-10-12
- Last updated
- 2024-12-02
- Results posted
- 2024-12-02
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04582877. Inclusion in this directory is not an endorsement.