This study is in progress, not accepting new patients

Observational Study to Assess Transradial Access for Treatment in the Lower Extremities.

a study on Peripheral Arterial Disease Vascular Disease

Eligibility: for people ages 18 years and up (full criteria)
Location: at La Jolla, California and other locations
Dates: study started June 2020
estimated completion January 2023

Description

Summary

This study is designed to collect data on the complication rates and procedural success of using a transradial access approach to treat peripheral lesions in the lower extremities of a real world population.

Official Title

Prospective, Multi-center, Observational, Post-market Study to Assess the Safety and Procedural Success of Performing Transradial Access for Treatment of Atherosclerotic Lesions in the Lower Extremities.

Keywords

Peripheral Arterial Disease, Peripheral Vascular Diseases, Peripheral Artery Treatment

Eligibility

You can join if…

Open to people ages 18 years and up

Rutherford Category 2-5
Subject scheduled for a transradial intervention to treat a lesion in the lower extremities.
Willing to sign consent and agree to follow-up requirements.

You CAN'T join if...

Previous failed transradial access attempt
Presence of or planned dialysis fistula.
Planned amputation
Previous or planned transradial access intervention +/- 30 days
Radial artery diameter <2.5mm
No palpable radial artery
Established vasospastic disease
Known allergy to contrast that cannot be managed
Pregnant or lactating
Mentally incompetent or a prisoner
Currently participating in a clinical study that has not completed it's primary endpoint

Locations

UCSD
La Jolla California 92037 United States
Ascension Seton Hays Hospital
Kyle Texas 78640 United States

Details

Status: in progress, not accepting new patients
Start Date: June 2020
Completion Date: January 2023 (estimated)
Sponsor: Terumo Medical Corporation
ID: NCT04371861
Study Type: Observational
Participants: Expecting 120 study participants
Last Updated: October 2021