Observational Study to Assess Transradial Access for Treatment in the Lower Extremities. (R2P Registry)

Terumo

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Peripheral Artery Treatment

Study type: Observational

Funder types: Industry

Identifiers

NCT04371861

TIS2019-01

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

Treatment of lower extremity lesion via transradial access.

Description:

Interventions performed are standard of care for treatment of a peripheral lesion.

Treatment:

Device: Peripheral Artery Treatment