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

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

Recruiting
18 years and older
All
Phase N/A

Overview

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.

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 details
    Peripheral vascular disease
    Peripheral vascular disease
    peripheral arterial disease

NCT04371861

Terumo Medical Corporation

16 February 2024

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