Cardiac Positioning System in Peripheral Angioplasty Procedure. (MDG-Periph)

Abbott

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Procedure: Navigation

Study type: Observational

Funder types: Industry

Identifiers

NCT03585387

10252

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age;
• Scheduled for clinically indicated or contemplated percutaneous transluminal angioplasty or stenting of an peripheral artery;
• Able to provide informed consent for study participation and willing and able to comply with the Clinical Investigational Plan described evaluation.

Exclusion criteria

• Pregnant women or women planning to be pregnant during the study.
• Patients currently participating in another clinical study
• Patients with a thrombophilia
• Patients with critical limb ischemia
• Patients with unstable clinical condition or conditions limiting life expectancy that, in the opinion of the Study Investigator, excludes the participation.

Trial design

12 participants in 1 patient group

Main

Description:

Each subject in this group will be its own control for the two navigation methods.

Treatment:

Procedure: Navigation