Observational Study to Assess Transradial Access for Treatment in the Lower Extremities.
R2P Registry
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.
1 other identifier
observational
120
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2020
CompletedFirst Posted
Study publicly available on registry
May 1, 2020
CompletedStudy Start
First participant enrolled
June 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJuly 10, 2023
June 1, 2021
1.2 years
April 29, 2020
July 6, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Radial access site complications
Rates of occurrence in complications associated with transradial access.
Procedure
Procedural Success
Successful completion of intended procedure without access complications and without conversion to femoral access.
Procedure
Study Arms (1)
Treatment of lower extremity lesion via transradial access.
Interventions performed are standard of care for treatment of a peripheral lesion.
Interventions
Peripheral lesions may be treated by any standard of care methods of treatment.
Eligibility Criteria
Subjects planned to undergo treatment of a lower extremity lesion via transradial artery access.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
UCSD
La Jolla, California, 92037, United States
Northside Hospital
St. Petersburg, Florida, 33709, United States
Cardiovascular Institute of the South
Lafayette, Louisiana, 70503, United States
Mercy Hospital
Springfield, Missouri, 65804, United States
Columbia University Medical Center
New York, New York, 10032, United States
Sorin Medical, Inc.
New York, New York, 10065, United States
University Hospitals
Cleveland, Ohio, 44106, United States
Ascension Seton Hays Hospital
Kyle, Texas, 78640, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mehdi Shishehbor, DO
University Hospitals, Cleveland, OH
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2020
First Posted
May 1, 2020
Study Start
June 29, 2020
Primary Completion
August 28, 2021
Study Completion
June 30, 2022
Last Updated
July 10, 2023
Record last verified: 2021-06