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CompletedNCT04371861R2P RegistryUpdated Oct 22, 2026Results posted

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

An observational study in Peripheral Arterial Disease, sponsored by Terumo Medical Corporation. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Terumo Medical Corporation (part of Terumo Corporation) · Observational

Updated Oct 22, 2026Results postedPrimary outcomes revisedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Peripheral Arterial Disease
03

In context

Peripheral Arterial Disease

1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.

This study's enrollment of 120 is below the median of 190 across 427 observational studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Terumo Medical Corporation is the lead sponsor of 8 studies on the registry; none are open to participants now.

Browse Terumo Medical Corporation studies →All Terumo Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • Treatment of lower extremity lesion via transradial access.

    Interventions performed are standard of care for treatment of a peripheral lesion.

    Device: Peripheral Artery Treatment

Interventions

  • DevicePeripheral Artery Treatment

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

06

What researchers measure

Primary outcomes

  1. Procedural Success

    Subjects with no femoral conversion or transradial access site complications at procedure

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

  2. Transradial Access Site Complications

    Patients with serious transradial access site complications at any timepoint

    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.

07

Results

Posted Oct 22, 2026

Participant flow

All Subject 30 Day FU
Participant flow — All Subject 30 Day FU
MilestoneTreatment of Lower Extremity Lesion Via Transradial Access.
Started120
Completed115
Not completed5
Withdrew: Death1
Withdrew: Lost to follow-up1
Withdrew: Withdrawal by subject3
Misago 12 month FU
Participant flow — Misago 12 month FU
MilestoneTreatment of Lower Extremity Lesion Via Transradial Access.
Started46
Completed41
Not completed5
Withdrew: Lost to follow-up1
Withdrew: Lost to follow-up1
Withdrew: Protocol violation3

Outcome measures

PrimaryProcedural Success

Subjects with no femoral conversion or transradial access site complications at procedure

Time frame:
This outcome was measured from the point of enrollment through the completion of the index procedure.
Reported as:
Count of participants · Participants
Procedural Success
ParticipantsTreatment of Lower Extremity Lesion Via Transradial Access.
Procedural Success113
Patients requiring femoral conversion1
Patients with transradial access site complications6
PrimaryTransradial Access Site Complications

Patients with serious transradial access site complications at any timepoint

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.
Reported as:
Count of participants · Participants
Transradial Access Site Complications
ParticipantsTreatment of Lower Extremity Lesion Via Transradial Access.
Patients with serious transradial access site complications at any timepoint0
Patients with non-serious transradial access site complications at any timepoint25

Adverse events

Collected over 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.. Non-serious events are listed at a 0.5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment of Lower Extremity Lesion Via Transradial Access.3/120 (2.5%)21/120 (17.5%)38/120 (31.7%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
EventTreatment of Lower Extremity Lesion Via Transradial Access.
Acute myocardial infarctionCardiac disorders1/120
AppendicitisInfections and infestations1/120
ArrhythmiaCardiac disorders1/120
Atrial fibrillationCardiac disorders1/120
Chest painCardiac disorders1/120
Chronic left ventricular failureCardiac disorders1/120
Corona virus infectionInfections and infestations1/120
CystitisInfections and infestations1/120
Femoral Artery DissectionVascular disorders1/120
Peripheral Artery DissectionVascular disorders1/120
Most frequent other events
Showing 10 of 14
Most frequent other events
EventTreatment of Lower Extremity Lesion Via Transradial Access.
Vascular access site hemorrhageVascular disorders10/120
Vascular access site hematomaVascular disorders7/120
Vascular access site bruisingVascular disorders4/120
Vascular access site swellingVascular disorders4/120
Peripheral swellingMusculoskeletal and connective tissue disorders3/120
VasospasmVascular disorders3/120
Vascular access site occlusionVascular disorders2/120
Application site lacerationInjury, poisoning and procedural complications1/120
Arterial SpasmVascular disorders1/120
ArthralgiaMusculoskeletal and connective tissue disorders1/120

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment of Lower Extremity Lesion Via Transradial Access.
Mean68.7 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)Treatment of Lower Extremity Lesion Via Transradial Access.
Female38
Male82
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment of Lower Extremity Lesion Via Transradial Access.
Hispanic or Latino14
Not Hispanic or Latino106
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment of Lower Extremity Lesion Via Transradial Access.
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American29
White87
More than one race4
Unknown or Not Reported0
Baseline Rutherford Classification
Baseline Rutherford Classification(Participants)Treatment of Lower Extremity Lesion Via Transradial Access.
Class 218
Class 368
Class 426
Class 58
Coronary artery disease
Coronary artery disease(Participants)Treatment of Lower Extremity Lesion Via Transradial Access.
Yes68
No49
Unknown3
Renal insufficiency
Renal insufficiency(Participants)Treatment of Lower Extremity Lesion Via Transradial Access.
Yes16
No103
Unknown1
Diabetes mellitus
Diabetes mellitus(Participants)Treatment of Lower Extremity Lesion Via Transradial Access.
Yes59
No61

3 further baseline measures are reported on the registry.

08

Study locations

8 sites
  • 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
09

References and documents

Study documents

  • Study protocol · Oct 19, 2020
  • Statistical analysis plan · Apr 8, 2022

Documents are hosted by the registry — open the source record to download them.

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2020 to primary completion in Aug 2021, 13 months.

Results were first posted in Oct 2026, 5 years 1 month after primary completion.

Of 58 industry-sponsored observational studies under Peripheral Arterial Disease, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 39. This study's 13 months is below that.

Counting every sponsor, half of 197 studies reached it within 37 months; a quarter within 23 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2020
First posted
May 1, 2020
StartActual
Jun 29, 2020
Primary completionActual
Aug 28, 2021
CompletionActual
Jun 30, 2022
Results first posted
Oct 22, 2026
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Results
Results posted
posted Oct 22, 2026
Also revised
primary outcomes
Show all 1 update
  1. Oct 22, 2026
    Results posted
    Primary outcomes Revised (4 changes)
    + 4 other changes: registry notes, index terms, verification date and documents

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT04371861
Lead sponsor
Terumo Medical Corporation
Responsible party
Sponsor
First posted
May 1, 2020
Start date
Jun 29, 2020
Primary completion
Aug 28, 2021
Completion
Jun 30, 2022
Results posted
Oct 22, 2026
Last update
Oct 22, 2026

Study contacts

Mehdi Shishehbor, DO
principal investigator · University Hospitals, Cleveland, OH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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