Status:

COMPLETED

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

Lead Sponsor:

Terumo Medical Corporation

Conditions:

Peripheral Arterial Disease

Eligibility:

All Genders

18+ years

Brief 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 popu...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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

Key Trial Info

Start Date :

June 29 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 30 2022

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT04371861

Start Date

June 29 2020

End Date

June 30 2022

Last Update

July 10 2023

Active Locations (8)

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Page 1 of 2 (8 locations)

1

UCSD

La Jolla, California, United States, 92037

2

Northside Hospital

St. Petersburg, Florida, United States, 33709

3

Cardiovascular Institute of the South

Lafayette, Louisiana, United States, 70503

4

Mercy Hospital

Springfield, Missouri, United States, 65804