ClinicalTrials.gov

History of Changes for Study: NCT03193619
Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon
Latest version (submitted May 10, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 June 19, 2017 None (earliest Version on record)
2 July 19, 2017 Contacts/Locations and Study Status
3 July 25, 2017 Contacts/Locations and Study Status
4 August 25, 2017 Study Status and Contacts/Locations
5 September 7, 2017 Study Status
6 September 27, 2017 Contacts/Locations and Study Status
7 September 28, 2017 Oversight and Study Status
8 November 13, 2017 Contacts/Locations and Study Status
9 November 23, 2017 Contacts/Locations and Study Status
10 December 21, 2017 Contacts/Locations and Study Status
11 January 11, 2018 Study Status and Contacts/Locations
12 January 25, 2018 Contacts/Locations and Study Status
13 February 6, 2018 Study Status
14 February 26, 2018 Contacts/Locations and Study Status
15 March 20, 2018 Study Status and Contacts/Locations
16 March 28, 2018 Recruitment Status, Study Status and Contacts/Locations
17 April 9, 2018 Study Status and Contacts/Locations
18 May 3, 2018 Contacts/Locations and Study Status
19 May 25, 2018 Study Status
20 June 22, 2018 Study Status
21 July 27, 2018 Study Status
22 August 14, 2018 Study Status and Outcome Measures
23 August 21, 2018 Contacts/Locations and Study Status
24 September 13, 2018 Study Status and Contacts/Locations
25 October 5, 2018 Study Status
26 November 26, 2018 Study Status
27 December 18, 2018 Study Status and Contacts/Locations
28 January 11, 2019 Study Status and Contacts/Locations
29 February 25, 2019 Study Status
30 May 6, 2019 Study Status
31 June 3, 2019 Study Status
32 September 5, 2019 Study Status
33 November 22, 2019 Study Status and Contacts/Locations
34 January 10, 2020 Study Status and Contacts/Locations
35 January 24, 2020 Contacts/Locations and Study Status
36 March 6, 2020 Study Status and Contacts/Locations
37 April 21, 2020 Study Status
38 May 5, 2020 Study Status
39 July 29, 2020 Study Status
40 August 21, 2020 Study Status
41 November 9, 2020 Study Status
42 December 4, 2020 Study Status and Contacts/Locations
43 January 15, 2021 Study Status
44 August 6, 2021 Study Status
45 September 20, 2021 Recruitment Status, Study Status and Study Design
46 January 10, 2022 Study Status
47 February 24, 2022 Study Status
48 May 10, 2022 Recruitment Status and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT03193619
Submitted Date:  June 19, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: BPV-16-001
Brief Title: Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon
Official Title: A Prospective, Multi-Center, Single-Arm, Real-World Study Assessing the Clinical Use of the Bard® UltraScore™ Focused Force PTA Balloon
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2017
Overall Status: Not yet recruiting
Study Start: August 2017
Primary Completion: August 2019 [Anticipated]
Study Completion: October 2019 [Anticipated]
First Submitted: June 19, 2017
First Submitted that
Met QC Criteria:
June 19, 2017
First Posted: June 21, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
June 19, 2017
Last Update Posted: June 21, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: C. R. Bard
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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.
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.
Open or close this module Conditions
Conditions: Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Keywords:
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 350 [Anticipated]
Number of Groups/Cohorts 1
Target Follow-Up Duration: 1 Year
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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.

Open or close this module Outcome Measures
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 coronary 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.
Open or close this module Eligibility
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).
Sampling Method: Non-Probability Sample
Minimum Age: 21 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Josh Smale
Telephone: +1-480-379-2838
Email: Josh.Smale@crbard.com
Central Contact Backup: Ryan Melloy
Telephone: +1-480-350-6074
Email: ryan.melloy@crbard.com
Study Officials: Craig Walker, MD
Principal Investigator
Cardiovascular Institute of the South (CIS) Clinical Research Corporation
Robert Beasley, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Miguel Montero, MD
Principal Investigator
Baylor St. Luke's College of Medicine
Locations: United States, Arizona
St. Luke's Hospital- Phoenix
Phoenix, Arizona, United States, 85006
Contact:Contact: Renata Schwartz 602-251-8890
Contact:Principal Investigator: Richard Heuser, MD
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
Contact:Contact: Jacqueline Gamberdella 203-737-3427
Contact:Principal Investigator: Glen Henry, MD
United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Contact:Contact: Nancy Cabrera 305-439-5208
Contact:Principal Investigator: Robert Beasley, MD
United States, Hawaii
Kaiser Foundation Hospitals
Honolulu, Hawaii, United States, 96819
Contact:Contact: Alex Kang 808-432-5555 Ext. 1453
Contact:Principal Investigator: Peter Schneider, MD
United States, Indiana
St. Joseph Hospital
Fort Wayne, Indiana, United States, 46802
Contact:Contact: Cheryl Bair 260-423-1331
Contact:Principal Investigator: Louis Lopez, MD
Community Hospital Munster Research Foundation
Munster, Indiana, United States, 46321
Contact:Contact: Cheryl Smyth 219-836-7026
Contact:Principal Investigator: Samer Abbas, MD
United States, Louisiana
Willis Knighton Medical Center
Bossier City, Louisiana, United States, 71112
Contact:Contact: Kristen Terry 601-813-1345
Contact:Principal Investigator: Britton Eaves, MD
CIS Clinical Research Corporation
Houma, Louisiana, United States, 70360
Contact:Contact: Deanna Benoit 985-876-0300
Contact:Principal Investigator: Craig Walker, MD
United States, Massachusetts
Beth Israel Deaconess Medical Center, Inc
Boston, Massachusetts, United States, 02215
Contact:Contact: Mary Trovato 617-632-7488
Contact:Principal Investigator: Marc Schermerhorn, MD
United States, Mississippi
Jackson Heart Clinic, P.A
Jackson, Mississippi, United States, 39216
Contact:Contact: Sandy Puckett 601-366-8507
Contact:Principal Investigator: James Bennett, MD
United States, Missouri
SSM DePaul Health Center
Bridgeton, Missouri, United States, 63044
Contact:Contact: Nicole Elmore 314-741-0911
Contact:Principal Investigator: Sundeep Das, MD
Kansas City Vascular Foundation
Kansas City, Missouri, United States, 64116
Contact:Contact: Nikki Kramer 816-659-8193
Contact:Principal Investigator: Scott Kujath, MD
Cox Medical Center
Springfield, Missouri, United States, 65807
Contact:Contact: Uriah Atkinson 417-269-0511
Contact:Principal Investigator: John Mullins, MD
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Contact:Contact: Michael Gallo 978-848-8186
Contact:Principal Investigator: Parakash Krishnan, MD
Staten Island University Hospital
Staten Island, New York, United States, 10305
Contact:Contact: Maria Scrabilia 718-226-6800
Contact:Principal Investigator: Kuldeep Singh, MD
United States, North Carolina
LeBauer Cardiovascular REsearch Foundation
Greensboro, North Carolina, United States, 27401
Contact:Contact: Jennifer Knapp 336-832-3795
Contact:Principal Investigator: Wells Brabham, MD
Rex Hospital, Inc
Raleigh, North Carolina, United States, 27607
Contact:Contact: Susan Wilkinson 919-787-5380
Contact:Principal Investigator: George Adams, MD
Coastal Surgery Specialists
Wilmington, North Carolina, United States, 28401
Contact:Contact: Tracy Helm 910-343-0811
Contact:Principal Investigator: David Weatherford, MD
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Contact:Contact: Lori Russell 503-494-7660
Contact:Principal Investigator: Khashayar Farsad, MD
United States, Pennsylvania
Saint Vincent Consultants in Cardiovascular Diseases, LLC
Erie, Pennsylvania, United States, 16502
Contact:Contact: Tara Friedman 814-453-7767 Ext. 2315
Contact:Principal Investigator: Matthew Becker, MD
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, United States, 17043
Contact:Contact: Laura Wells 717-731-0101 Ext. 3151
Contact:Contact: Gretchen Maise 717-731-0101 Ext. 4280
Contact:Principal Investigator: William Bachinsky, MD
United States, Texas
Baylor St. Luke's Health College of Medicine
Houston, Texas, United States, 77030
Contact:Contact: Alicia Marie Palao 713-798-7508
Contact:Principal Investigator: Miguel Montero, MD
The Methodist Hospital Research Institute dba Houston Methodist Research Institute
Houston, Texas, United States, 77030
Contact:Contact: Sheila Moore 218-274-8095
Contact:Principal Investigator: Imran Mohiuddin, MD
Grace Research, LLC
Huntsville, Texas, United States, 77340
Contact:Contact: Kristen Terry 601-813-1345
Contact:Principal Investigator: Gaurav Aggarwala, MD
Texas Tech University Health Science Center/University Medical Center
Lubbock, Texas, United States, 79430
Contact:Contact: Ronnie Orozco 806-743-6900
Contact:Principal Investigator: Mohammad Ansari, MD
United States, Virginia
Virginia Cardiovascular Specialists
Richmond, Virginia, United States, 23225
Contact:Contact: Laura Puckett 804-323-4029 Ext. 231
Contact:Principal Investigator: Ashwani Kumar, MD
United States, West Virginia
University Physicians and Surgeons d/b/a Marshall Health
Huntington, West Virginia, United States, 25701
Contact:Contact: Melissa Marcum 304-691-8561
Contact:Principal Investigator: Mehiar El-Hamdani, MD
United States, Wisconsin
HSHS St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Contact:Contact: Cynthia Quinnell 920-272-1053
Contact:Principal Investigator: John Hutto, MD
Columbia St. Mary's, Inc.
Milwaukee, Wisconsin, United States, 53211
Contact:Contact: Cynthia Lessila 414-291-1497
Contact:Principal Investigator: Erik Stilp, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services