Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon

Completed

Conditions studied: Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases

In brief

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.

Key facts

Study ID

NCT03193619

Run by

C. R. Bard

People needed

350

Starts

2018-03-28

Expected to finish

2022-04-01

Last updated by the study team

2024-03-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
• Subject must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
• Subject must be willing to comply with the protocol requirements, including the follow-up procedures.
• Subject must have a target lesion (de novo lesion or prior failed treatment) that can be treated with the UltraScore™ Focused Force PTA balloon according to the Instructions for Use (IFU). Only a target lesion in the SFA, popliteal, or infra-popliteal arteries (posterior tibial, anterior tibial, or peroneal arteries) may be treated for this study.
• Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off.
• The target lesion must be able to be crossed using a guidewire (use of chronic total occlusion (CTO) or atherectomy is allowed).

You may not qualify if…

• Subjects that are to receive one or more stents as adjunctive therapy at the target lesion (bail out stenting is allowed).
• The subject has a single target lesion that involves both ATK and BTK arteries.
• The subject has a target lesion in a previously placed stent or stent graft (in-stent restenosis).
• The subject has a lesion, which in the opinion of the Investigator, would preclude safe use of the UltraScore™ Focused Force PTA balloon.
• The subject has a flow limiting dissection at the target lesion prior to use of the UltraScore™ Focused Force PTA balloon.
• The subject has acute limb ischemia.
• The subject has been assessed Rutherford category 6.
• The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
• The subject has another medical condition or is currently participating in an investigational drug or another device study that, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.

Where it is running

• St. Luke's Hospital- Phoenix — Phoenix, Arizona, United States
• Health One Denver Heart — Denver, Colorado, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• St. Joseph Hospital — Fort Wayne, Indiana, United States
• Community Hospital Munster Research Foundation — Munster, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• Willis Knighton Medical Center — Bossier City, Louisiana, United States
• CIS Clinical Research Corporation — Lafayette, Louisiana, United States
• MedStar Health Research Institute — Annapolis, Maryland, United States
• Beth Israel Deaconess Medical Center, Inc — Boston, Massachusetts, United States
• Providence-Providence Park Hospital — Southfield, Michigan, United States
• SSM DePaul Health Center — Bridgeton, Missouri, United States
• St. Louis Univeristy — St Louis, Missouri, United States
• Methodist Health System — Omaha, Nebraska, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Staten Island University Hospital — Staten Island, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• Rex Hospital, Inc — Raleigh, North Carolina, United States
• Coastal Surgery Specialists — Wilmington, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States
• US Cardiovascular Jefferson Hills — Jefferson Hills, Pennsylvania, United States
• Pinnacle Health Cardiovascular Institute — Wormleysburg, Pennsylvania, United States
• Vascular Access Solutions — Orangeburg, South Carolina, United States

Full record on ClinicalTrials.gov

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