NCT04371861
Completed
Not Applicable
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.
ConditionsPeripheral Arterial Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Terumo Medical Corporation
- Enrollment
- 120
- Locations
- 8
- Primary Endpoint
- Radial access site complications
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Radial access site complications
Time Frame: Procedure
Rates of occurrence in complications associated with transradial access.
Procedural Success
Time Frame: Procedure
Successful completion of intended procedure without access complications and without conversion to femoral access.
Study Sites (8)
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