Peripheral Arterial DiseaseR2P RegistryNCT04371861

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

An observational study of Peripheral Arterial Disease, run by Terumo Medical Corporation at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Arterial Disease
What is being tested?: Peripheral Artery Treatment
Type of treatment: Medical device
How many people: 120 participants
Where: 8 sitesUnited States
Study dates: 29 Jun 2020to 30 Jun 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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

Show all 11Show fewer

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 locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

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

Other trials in United States

About this study

Official 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.

Conditions: Peripheral Arterial Disease
Being tested: Peripheral Artery Treatment
Medical subject headings: Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04371861
Study group	Role	What they receive
Treatment of lower extremity lesion via transradial access.		Interventions performed are standard of care for treatment of a peripheral lesion. Receives: Device: Peripheral Artery Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Procedural Success
Subjects with no femoral conversion or transradial access site complications at procedure
Measured: This outcome was measured from the point of enrollment through the completion of the index procedure.
Transradial Access Site Complications
Patients with serious transradial access site complications at any timepoint
Measured: From the start of the index procedure (point of enrollment) through study exit, or up to 30 days or up to 1 year for participants who received a MISAGO stent.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 202030 Jun 2022

First posted1 May 2020
Study start29 Jun 2020
Primary completion28 Aug 2021
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04371861
Sponsor's protocol ID: TIS2019-01
Acronym: R2P Registry
Status last verified: Jul 2026
First submitted: 29 Apr 2020
Last updated: 22 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism

All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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.
ClinicalTrials.gov ID: NCT04371861
Acronym / sponsor ID: R2P Registry / TIS2019-01
Conditions: Peripheral Arterial Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Terumo Medical CorporationIndustry (pharma, biotech, devices)
Study start: 29 Jun 2020 (actual)
Primary completion: 28 Aug 2021 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 1 May 2020 (actual)
Results: Posted 22 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Treatment of lower extremity lesion via transradial access.	–	Device: Peripheral Artery TreatmentInterventions performed are standard of care for treatment of a peripheral lesion.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects planned to undergo treatment of a lower extremity lesion via transradial artery access.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peripheral Artery TreatmentPeripheral lesions may be treated by any standard of care methods of treatment.	Device	Treatment of lower extremity lesion via transradial access.

Primary outcome

Procedural Success
Time frame: This outcome was measured from the point of enrollment through the completion of the index procedure.
Subjects with no femoral conversion or transradial access site complications at procedure
Transradial Access Site Complications
Time frame: From the start of the index procedure (point of enrollment) through study exit, or up to 30 days or up to 1 year for participants who received a MISAGO stent.
Patients with serious transradial access site complications at any timepoint

Results and safety

Results posted to the registry on 22 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment of Lower Extremity Lesion Via Transradial Access.	120	115

Primary outcome: Procedural Success

Time frame: This outcome was measured from the point of enrollment through the completion of the index procedure.. Count of participants. Unit: Participants

Measure	Treatment of Lower Extremity Lesion Via Transradial Access. n = 120
Procedural Success	113
Patients requiring femoral conversion	1
Patients with transradial access site complications	6

Primary outcome: Transradial Access Site Complications

Time frame: From the start of the index procedure (point of enrollment) through study exit, or up to 30 days or up to 1 year for participants who received a MISAGO stent.. Count of participants. Unit: Participants

Measure	Treatment of Lower Extremity Lesion Via Transradial Access. n = 120
Patients with serious transradial access site complications at any timepoint	0
Patients with non-serious transradial access site complications at any timepoint	25

Adverse events

Time frame: Adverse events were collected beginning at the start of the index procedure and were collected through study exit, or up to 30 days from the index procedure, or up to 1 year for participants who received a MISAGO stent.. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment of Lower Extremity Lesion Via Transradial Access.	21 of 120 (17.5%)	38 of 120 (31.7%)	3 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peripheral Arterial Disease

RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mehdi Shishehbor, DO principal investigator

University Hospitals, Cleveland, OH

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease, run by Terumo Medical Corporation at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural Success (time frame: This outcome was measured from the point of enrollment through the completion of the index procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04371861.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.