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

Completed

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT04371861

Run by

Terumo Medical Corporation

People needed

120

Starts

2020-06-29

Expected to finish

2022-06-30

Last updated by the study team

2023-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

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

Full record on ClinicalTrials.gov

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