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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-29

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment of lower extremity lesion via transradial access.

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

Peripheral Artery Treatment

Intervention Type DEVICE

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

Interventions

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Peripheral Artery Treatment

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No