Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04582877
Status:
COMPLETED
Last Update Posted:
2020-10-12
First Post:
2020-09-17
Brief Title:
Pressure Guidewire System Multi-center Prospective Self-Control Clinical Trial
Sponsor:
Zurich Medical Inc
Organization:
Zurich Medical Inc
Study Overview
Official Title:
Pressure Guidewire System Multi-center Prospective Self-Control Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Medicals 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 Medicals 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 subjects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None