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

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Peripheral Artery Treatment

• Registration Number: NCT04371861
• Lead Sponsor: Terumo Medical Corporation

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 population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-05-01
• Study Start: 2020-06-29
• Status Verified: 2021-06
• Primary Completion: 2021-08-28
• Study Completion: 2022-06-30
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment of lower extremity lesion via transradial access.	Peripheral Artery Treatment	Interventions performed are standard of care for treatment of a peripheral lesion.

Primary Outcome Measures

Name	Time	Method
Radial access site complications	Procedure	Rates of occurrence in complications associated with transradial access.
Procedural Success	Procedure	Successful completion of intended procedure without access complications and without conversion to femoral access.

Trial Locations

Locations (8)

Ascension Seton Hays Hospital; 🇺🇸 Kyle, Texas, United States

Northside Hospital; 🇺🇸 Saint Petersburg, Florida, United States

Sorin Medical, Inc.; 🇺🇸 New York, New York, United States

Cardiovascular Institute of the South; 🇺🇸 Lafayette, Louisiana, United States

Mercy Hospital; 🇺🇸 Springfield, Missouri, United States

UCSD; 🇺🇸 La Jolla, California, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

University Hospitals; 🇺🇸 Cleveland, Ohio, United States