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NCT04371861 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

— R2P Registry  

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04371861
Other study ID # TIS2019-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 29, 2020
Est. completion date June 30, 2022

Study information
Verified date June 2021
Source Terumo Medical Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date June 30, 2022
Est. primary completion date August 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Peripheral Artery Treatment
Peripheral lesions may be treated by any standard of care methods of treatment.

Locations
Country Name City State
United States University Hospitals Cleveland Ohio
United States Ascension Seton Hays Hospital Kyle Texas
United States UCSD La Jolla California
United States Cardiovascular Institute of the South Lafayette Louisiana
United States Columbia University Medical Center New York New York
United States Sorin Medical, Inc. New York New York
United States Northside Hospital Saint Petersburg Florida
United States Mercy Hospital Springfield Missouri

Sponsors (1)
Lead Sponsor Collaborator
Terumo Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Radial access site complications Rates of occurrence in complications associated with transradial access. Procedure
Primary Procedural Success Successful completion of intended procedure without access complications and without conversion to femoral access. Procedure
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