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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03193619
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2017
Last Update Posted : January 27, 2020
Information provided by (Responsible Party):
C. R. Bard

Brief 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.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Peripheral Vascular Diseases Arterial Occlusive Diseases Device: PTA (UltraScore Focused Force PTA Balloon)

Detailed Description:
The registry is a prospective, multi-center, single-arm, real-world study to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal artery, and infra-popliteal arteries (posterior tibial, anterior tibial and peroneal arteries). Follow-up for all treated subjects will be performed at hospital discharge, 30 days, and 6 and 12 months post-index procedure.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Group/Cohort Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. Achieve optimal PTA results [ Time Frame: Index procedure (Day 0); approximate duration of procedure is 90 minutes. ]
    Optimal result is defined as ≤30% residual stenosis without major flow-limiting dissection, as measured by angiographic imaging. Major flow limiting dissections are classified by the National Heart, Lung, and Blood Institute (NHLBI) as Grade D (Spiral luminal filling defects), Grade E (Appearance of new and persistent filling defects with reduced flow), and Grade F (Total occlusion without distal flow).

  2. Technical success of use of UltraScore™ Focused Force PTA balloon [ Time Frame: Index procedure (Day 0); approximate duration of procedure is 90 minutes. ]
    Technical success is determined subjectively by the investigator according to delivery location of the study device relative to the target lesion, as assessed by angiographic imaging, and inflation without movement.

Secondary Outcome Measures :
  1. Rate of bail-out stenting due to dissection [ Time Frame: Index procedure (Day 0); approximate duration of procedure is 90 minutes. ]
    Rate of emergency artery stent placement for abrupt or threatened artery closure caused by arterial dissection immediately following index procedure.

  2. Freedom from target lesion revascularization (TLR). [ Time Frame: 30 days, 6 months, and 12 months post-index procedure ]
    TLR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in target vessel after the index procedure

  3. Freedom from major amputation of the target limb [ Time Frame: 30 days, 6 months, and 12 months post-index procedure ]
    Major amputation is defined as above the ankle amputation

  4. Improved clinical measures from baseline [ Time Frame: 30 days, 6 months, and 12 months post-index procedure ]
    Resting ankle brachial index (ABI) and Rutherford classification for chronic limb ischemia measurements will be assessed clinically at follow-up and compared with baseline.

  5. Primary patency for Above the Knee (ATK) subjects [ Time Frame: 30 days, 6 months, and 12 months post-index procedure ]
    ATK subjects have a target lesion of the SFA or popliteal artery only. Primary patency is measured by duplex ultrasound (DUS) core lab; a peak systolic velocity ratio (PSVR) ≥2.5 suggests 50% restenosis and loss of patency.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will include a maximum of 350 subjects at up to 45 U.S. sites. All subjects will have peripheral arterial disease (PAD; a stenotic lesion of the SFA, popliteal, or infra-popliteal arteries).

Inclusion Criteria:

  1. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
  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:

  1. Subjects that are to receive one or more stents as adjunctive therapy at the target lesion (bail out stenting is allowed).
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03193619

Hide Hide 31 study locations
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United States, Arizona
St. Luke's Hospital- Phoenix
Phoenix, Arizona, United States, 85006
United States, Colorado
Health One Denver Heart
Denver, Colorado, United States, 80220
United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Indiana
St. Joseph Hospital
Fort Wayne, Indiana, United States, 46802
Community Hospital Munster Research Foundation
Munster, Indiana, United States, 46321
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
Willis Knighton Medical Center
Bossier City, Louisiana, United States, 71112
CIS Clinical Research Corporation
Lafayette, Louisiana, United States, 70506
United States, Maryland
MedStar Health Research Institute
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Beth Israel Deaconess Medical Center, Inc
Boston, Massachusetts, United States, 02215
United States, Michigan
Providence-Providence Park Hospital
Southfield, Michigan, United States, 48075
United States, Missouri
SSM DePaul Health Center
Bridgeton, Missouri, United States, 63044
St. Louis Univeristy
Saint Louis, Missouri, United States, 63103
United States, Nebraska
Methodist Health System
Omaha, Nebraska, United States, 68114
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Mount Sinai School of Medicine
New York, New York, United States, 10029
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27858
Rex Hospital, Inc
Raleigh, North Carolina, United States, 27607
Coastal Surgery Specialists
Wilmington, North Carolina, United States, 28401
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
US Cardiovascular Jefferson Hills
Jefferson Hills, Pennsylvania, United States, 15025
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, United States, 17043
United States, South Carolina
Vascular Access Solutions
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Stern Cardiovascular Foundation, Inc
Germantown, Tennessee, United States, 38138
United States, Texas
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States, 78746
Baylor St. Luke's Health College of Medicine
Houston, Texas, United States, 77030
The Methodist Hospital Research Institute dba Houston Methodist Research Institute
Houston, Texas, United States, 77030
Texas Tech University Health Science Center/University Medical Center
Lubbock, Texas, United States, 79430
United States, Wisconsin
HSHS St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Sponsors and Collaborators
C. R. Bard
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Principal Investigator: Craig Walker, MD Cardiovascular Institute of the South (CIS) Clinical Research Corporation
Principal Investigator: Robert Beasley, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Miguel Montero, MD Baylor St. Luke's College of Medicine

Additional Information:

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Responsible Party: C. R. Bard Identifier: NCT03193619    
Other Study ID Numbers: BPV-16-001
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases