MedTrace Logo

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

NCT03193619 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2024-03-28

Study results available
· View outcomes & findings →

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.

Conditions

  • Peripheral Arterial Disease
  • Peripheral Vascular Diseases
  • Arterial 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.

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Craig Walker, MD · Cardiovascular Institute of the South (CIS) Clinical Research Corporation

  • Robert Beasley, MD · Icahn School of Medicine at Mount Sinai

  • Miguel Montero, MD · Baylor St. Luke's College of Medicine

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-28
Primary Completion
2020-10-29
Completion
2022-04-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03193619 on ClinicalTrials.gov