Summary

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

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
Completion Date
(estimated)
Sponsor
Terumo Medical Corporation
ID
NCT04371861
Study Type
Observational
Participants
Expecting 120 study participants
Last Updated