Cardiac Positioning System in Peripheral Angioplasty Procedure.

NCT03585387 | Completed

• 1 other identifier: 10252
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Time of radiation

  Medical radiation exposure for each balloon positioning

  Changes from time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over 2 hours.

Secondary Outcomes (6)

• Time duration

  From time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over a 2 hours time frame.

• Dose area product (DAP)

  DAP change from when balloon leaves the sheath to final alignment with anatomical landmark assessed every 15 minutes over a 2 hours time frame.

• Success or no-success in balloon navigation

  Determined every 15 minutes over a 2 hours time frame.

• Volume of contrast required to get the balloon to the anatomical landmark.

  Change of volume of contrast from when balloon leaves the sheath to final alignment with anatomical landmark assessed every 15 minutes over a 2 hours time frame.

• Distance measurements

  At end of procedure

Study Arms (1)

Main

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

Procedure: Navigation

Interventions

Navigation PROCEDURE

Navigation of a balloon catheter using two navigation methods (1-Fluoroscopy only; 2- Fluoroscopy + CPS).

Main

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a prospective single-center, acute data collection study in 12 patients suffering from a peripheral arterial disease with an indication for an angioplasty procedure.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 13, 2018
• Study Start: February 27, 2019
• Primary Completion: May 10, 2020
• Study Completion: June 9, 2020
• Last Updated: June 11, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)