At a glance
ClinicalIndex Comparison Record- ✓Age ≥21 years with expected lifespan sufficient to complete study procedures
- ✓Target lesion in SFA, popliteal, or infra-popliteal arteries (posterior tibial, anterior tibial, or peroneal)
- ✓De novo or prior failed lesion treatable per UltraScore Instructions for Use
- ✓ATK or BTK target lesion with at least one vessel run-off
- ✕Target lesion requires stent placement (bail-out stenting allowed)
- ✕Target lesion involves both ATK and BTK arteries
- ✕In-stent restenosis or lesion in previously placed stent/stent graft
- ✕Flow-limiting dissection at target lesion prior to PTA balloon use
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon
In Brief
An observational study evaluating PTA (UltraScore Focused Force PTA Balloon) for Peripheral Arterial Disease and 2 related conditions. Completed, enrolled 350 participants across 31 sites.
Detailed Summary
The objective of this study is to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon in a heterogeneous patient population in a real world, on-label clinical application.
Study Details
Timeline
Interventions
Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough. The UltraScore Focused Force PTA balloon through the blood vessel to the narrowed area to be treated.