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



Status:Enrolling by invitation
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:2/28/2019
Start Date:March 28, 2018
End Date:April 2020

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

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.

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.

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.
We found this trial at
30
sites
475 Seaview Ave
Staten Island, New York 10305
(718) 226-9000
Principal Investigator: Kuldeep Singh, MD
Phone: 718-226-6800
Staten Island University Hospital Staten Island University Hospital is a 714-bed, specialized teaching hospital located...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Marc Schermerhorn, MD
Phone: 617-632-7488
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Jose Wiley, MD
Phone: 718-920-8576
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Khashayar Farsad, MD
Phone: 503-494-7660
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Annapolis, Maryland 21401
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Annapolis, MD
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Austin, TX
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2600 Greenwood Road
Bossier City, Louisiana 71112
Principal Investigator: Britton Eaves, MD
Phone: 601-813-1345
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Bossier City, LA
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Bridgeton, Missouri 63044
Principal Investigator: Sundeep Das, MD
Phone: 314-741-0911
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4567 East 9th Avenue
Denver, Colorado 80220
Principal Investigator: Sameer Mehta, MD
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Fort Wayne, Indiana 46802
Principal Investigator: Louis Lopez, MD
Phone: 260-423-1331
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Germantown, Tennessee 38138
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835 S Van Buren St
Green Bay, Wisconsin 54307
Principal Investigator: John Hutto, MD
Phone: 920-272-1053
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6620 Main Street
Houston, Texas 77030
Principal Investigator: Miguel Montero, MD
Phone: 713-798-7508
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6670 Bertner Avenue
Houston, Texas 77030
Principal Investigator: Imran Mohiuddin, MD
Phone: 218-274-8095
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1600 Medical Center Drive
Huntington, West Virginia 25701
Principal Investigator: Mehiar El-Hamdani, MD
Phone: 304-691-8561
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Melhem Sharafuddin, MD
Phone: 319-353-8736
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Lafayette, Louisiana 70506
Principal Investigator: Craig Walker, MD
Phone: 985-876-0300
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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3601 4th Street
Lubbock, Texas 79430
Principal Investigator: Mohammad Ansari, MD
Phone: 806-743-6900
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Miami Beach, Florida 33140
Principal Investigator: Robert Beasley, MD
Phone: 305-439-5208
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926 Ridge Road
Munster, Indiana 46321
Principal Investigator: Samer Abbas, MD
Phone: 219-836-7026
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Munster, IN
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New York, New York 10029
Principal Investigator: Parakash Krishnan, MD
Phone: 978-848-8186
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Omaha, Nebraska 68114
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Orangeburg, South Carolina 29118
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Phoenix, Arizona 85006
Principal Investigator: Richard Heuser, MD
Phone: 602-251-8890
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Raleigh, North Carolina 27607
Principal Investigator: George Adams, MD
Phone: 919-787-5380
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1 North Grand Boulevard
Saint Louis, Missouri 63103
Principal Investigator: Matthew Smeds, MD
Phone: 314-577-8461
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16001 West Nine Mile Road
Southfield, Michigan 48075
Principal Investigator: Patrick Alexander, MD
Phone: 248-849-3369
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Wilmington, North Carolina 28401
Principal Investigator: David Weatherford, MD
Phone: 910-343-0811
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Wormleysburg, Pennsylvania 17043
Principal Investigator: William Bachinsky, MD
Phone: 717-731-0101
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