Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon
NCT ID: NCT03193619
Last Updated: 2024-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
350 participants
OBSERVATIONAL
2018-03-28
2022-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Subject must be willing to comply with the protocol requirements, including the follow-up procedures.
4. 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.
5. Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off.
6. The target lesion must be able to be crossed using a guidewire (use of chronic total occlusion (CTO) or atherectomy is allowed).
Exclusion Criteria
2. The subject has a single target lesion that involves both ATK and BTK arteries.
3. The subject has a target lesion in a previously placed stent or stent graft (in-stent restenosis).
4. The subject has a lesion, which in the opinion of the Investigator, would preclude safe use of the UltraScore™ Focused Force PTA balloon.
5. The subject has a flow limiting dissection at the target lesion prior to use of the UltraScore™ Focused Force PTA balloon.
6. The subject has acute limb ischemia.
7. The subject has been assessed Rutherford category 6.
8. The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
9. 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.
21 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Craig Walker, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Institute of the South (CIS) Clinical Research Corporation
Robert Beasley, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Miguel Montero, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor St. Luke's College of Medicine
Locations
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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
Stern Cardiovascular Foundation, Inc
Germantown, Tennessee, United States
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States
Baylor St. Luke's Health College of Medicine
Houston, Texas, United States
The Methodist Hospital Research Institute dba Houston Methodist Research Institute
Houston, Texas, United States
Texas Tech University Health Science Center/University Medical Center
Lubbock, Texas, United States
HSHS St. Vincent Hospital
Green Bay, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BPV-16-001
Identifier Type: -
Identifier Source: org_study_id
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