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

Prospective, Multi-center, Observational, Post-market Study to Assess the Safety and Procedural Success of Performing Transradial Access for Treatment of Atherosclerotic Lesions in the Lower Extremities.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04371861

Acronym

R2P Registry

Enrollment

120

Registered

2020-05-01

Start date

2020-06-29

Completion date

2022-06-30

Last updated

2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

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.

Interventions

DEVICEPeripheral Artery Treatment

Peripheral lesions may be treated by any standard of care methods of treatment.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026