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

T

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

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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