Trials / Completed
CompletedNCT03585387
Cardiac Positioning System in Peripheral Angioplasty Procedure.
Fluoroscopy vs Cardiac Positioning System Comparison to Assist the Navigation and Positioning of a Balloon Catheter in a Peripheral Artery During an Angioplasty Procedure
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This clinical investigation is intended to evaluate the ability of a magnetic cardiac positioning system to decrease medical radiation exposure on a peripheral angioplasty procedure in patients with a peripheral artery stenosis.
Detailed description
The present study aims at addressing the fluoroscopy exposure time concern among physicians by proposing a new methodology that capitalizes on the cardiac positioning system (CPS) to reach near-zero fluoroscopy time for interventional cardiologists. Intracoronary navigation of balloon catheter toward an anatomical landmark will be done with two navigation method: 1. Fluoroscopy alone 2. Fluoroscopy + CPS combination. The order of the navigation method (method 1 then method 2 or vice versa) will be determine arbitrarily determined for each subject.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Navigation | Navigation of a balloon catheter using two navigation methods (1-Fluoroscopy only; 2- Fluoroscopy + CPS). |
Timeline
- Start date
- 2019-02-27
- Primary completion
- 2020-05-10
- Completion
- 2020-06-09
- First posted
- 2018-07-13
- Last updated
- 2020-06-11
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT03585387. Inclusion in this directory is not an endorsement.