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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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