Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Arterial Occlusive Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
Description
The registry is a prospective, multi-center, single-arm, real-world study to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal artery, and infra-popliteal arteries (posterior tibial, ant...
The registry is a prospective, multi-center, single-arm, real-world study to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal artery, and infra-popliteal arteries (posterior tibial, anterior tibial and peroneal arteries). Follow-up for all treated subjects will be performed at hospital discharge, 30 days, and 6 and 12 months post-index procedure.
Tracking Information
- NCT #
- NCT03193619
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Craig Walker, MD Cardiovascular Institute of the South (CIS) Clinical Research Corporation Principal Investigator: Robert Beasley, MD Icahn School of Medicine at Mount Sinai Principal Investigator: Miguel Montero, MD Baylor St. Luke's College of Medicine
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