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

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.

Completed

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSD, La Jolla, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripheral Artery Treatment

Device

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

Primary outcomes

Radial access site complications

Time frame: Procedure

Rates of occurrence in complications associated with transradial access.
Procedural Success

Time frame: Procedure

Successful completion of intended procedure without access complications and without conversion to femoral access.

Sponsors and collaborators

Lead sponsor

Terumo Medical Corporation

Industry

Registry information

Official study title

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.

Acronym: R2P Registry

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2022
First posted: May 1, 2020
Registry last updated: Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed