A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon

Status: Completed
Location: See all (31) locations...
Intervention Type: Device
Study Type: Observational [Patient Registry]
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: No
View:

• 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).

Locations
United States
Arizona
St. Luke's Hospital- Phoenix
Phoenix
Colorado
Health One Denver Heart
Denver
Florida
Mount Sinai Medical Center
Miami Beach
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Indiana
St. Joseph Hospital
Fort Wayne
Community Hospital Munster Research Foundation
Munster
Kentucky
University of Kentucky
Lexington
Louisiana
Willis Knighton Medical Center
Bossier City
CIS Clinical Research Corporation
Lafayette
Massachusetts
Beth Israel Deaconess Medical Center, Inc
Boston
Maryland
MedStar Health Research Institute
Annapolis
Michigan
Providence-Providence Park Hospital
Southfield
Missouri
SSM DePaul Health Center
Bridgeton
St. Louis Univeristy
Saint Louis
North Carolina
East Carolina University
Greenville
Rex Hospital, Inc
Raleigh
Coastal Surgery Specialists
Wilmington
Nebraska
Methodist Health System
Omaha
New York
Montefiore Medical Center
Bronx
Mount Sinai School of Medicine
New York
Staten Island University Hospital
Staten Island
Oregon
Oregon Health & Science University
Portland
Pennsylvania
US Cardiovascular Jefferson Hills
Jefferson Hills
Pinnacle Health Cardiovascular Institute
Wormleysburg
South Carolina
Vascular Access Solutions
Orangeburg
Tennessee
Stern Cardiovascular Foundation, Inc
Germantown
Texas
Cardiothoracic and Vascular Surgeons
Austin
Baylor St. Luke's Health College of Medicine
Houston
The Methodist Hospital Research Institute dba Houston Methodist Research Institute
Houston
Texas Tech University Health Science Center/University Medical Center
Lubbock
Wisconsin
HSHS St. Vincent Hospital
Green Bay
Time Frame
Start Date: March 28, 2018
Completion Date: April 1, 2022
Participants
Target number of participants: 350
Treatments
PTA-UltraScore Focused Force PTA balloon
Treatment with the UltraScore Focused Force PTA balloon will be per the investigational site's standard of care and adhering to the IFU.
Sponsors
Leads: C. R. Bard

This content was sourced from clinicaltrials.gov

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