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

July 6, 2023 updated by: Terumo Medical Corporation

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • UCSD
    • Florida
      • Saint Petersburg, Florida, United States, 33709
        • Northside Hospital
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Cardiovascular Institute of the South
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10065
        • Sorin Medical, Inc.
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals
    • Texas
      • Kyle, Texas, United States, 78640
        • Ascension Seton Hays Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects planned to undergo treatment of a lower extremity lesion via transradial artery access.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment of lower extremity lesion via transradial access.
Interventions performed are standard of care for treatment of a peripheral lesion.
Device: Peripheral Artery Treatment
Peripheral lesions may be treated by any standard of care methods of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radial access site complications
Time Frame: Procedure
Rates of occurrence in complications associated with transradial access.
Procedure
Procedural Success
Time Frame: Procedure
Successful completion of intended procedure without access complications and without conversion to femoral access.
Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Terumo Medical Corporation

Investigators

  • Principal Investigator: Mehdi Shishehbor, DO, University Hospitals, Cleveland, OH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2020

Primary Completion (Actual)

August 28, 2021

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIS2019-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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