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

CompletedOBSERVATIONAL
Enrollment

350

Participants

Timeline

Start Date

March 28, 2018

Primary Completion Date

October 29, 2020

Study Completion Date

April 1, 2022

Conditions
Peripheral Arterial DiseasePeripheral Vascular DiseasesArterial Occlusive Diseases
Interventions
DEVICE

PTA (UltraScore Focused Force PTA Balloon)

"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."

Trial Locations (31)

10029

Mount Sinai School of Medicine, New York

10305

Staten Island University Hospital, Staten Island

10467

Montefiore Medical Center, The Bronx

15025

US Cardiovascular Jefferson Hills, Jefferson Hills

17043

Pinnacle Health Cardiovascular Institute, Wormleysburg

21401

MedStar Health Research Institute, Annapolis

27607

Rex Hospital, Inc, Raleigh

27858

East Carolina University, Greenville

28401

Coastal Surgery Specialists, Wilmington

29118

Vascular Access Solutions, Orangeburg

33140

Mount Sinai Medical Center, Miami Beach

38138

Stern Cardiovascular Foundation, Inc, Germantown

40536

University of Kentucky, Lexington

46321

Community Hospital Munster Research Foundation, Munster

46802

St. Joseph Hospital, Fort Wayne

48075

Providence-Providence Park Hospital, Southfield

52242

University of Iowa Hospitals and Clinics, Iowa City

54301

HSHS St. Vincent Hospital, Green Bay

63044

SSM DePaul Health Center, Bridgeton

63103

St. Louis Univeristy, St Louis

68114

Methodist Health System, Omaha

70506

CIS Clinical Research Corporation, Lafayette

71112

Willis Knighton Medical Center, Bossier City

77030

Baylor St. Luke's Health College of Medicine, Houston

The Methodist Hospital Research Institute dba Houston Methodist Research Institute, Houston

78746

Cardiothoracic and Vascular Surgeons, Austin

79430

Texas Tech University Health Science Center/University Medical Center, Lubbock

80220

Health One Denver Heart, Denver

85006

St. Luke's Hospital- Phoenix, Phoenix

97239

Oregon Health & Science University, Portland

02215

Beth Israel Deaconess Medical Center, Inc, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

C. R. Bard

INDUSTRY

NCT03193619 - Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon | Biotech Hunter | Biotech Hunter