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

NCT03193619 | Completed Results FDA Device

• 1 other identifier: BPV-16-001
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 31

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.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases

Outcome Measures

Primary Outcomes (2)

• Number of Participants That Achieve Optimal PTA Results

  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).

  Index procedure (Day 0); approximate duration of procedure is 90 minutes.

• Number of Participants With Technical Success of Use of UltraScore™ Focused Force PTA Balloon

  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.

  Index procedure (Day 0); approximate duration of procedure is 90 minutes.

Secondary Outcomes (16)

• Number of Participants With Bail-out Stenting Due to Dissection

  Index procedure (Day 0); approximate duration of procedure is 90 minutes.

• Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).

  30 days post-index procedure

• Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).

  6 months post-index procedure

• Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).

  12 months post-index procedure

• Number of Participants That Did Not Have a Major Amputation of the Target Limb

  30 days post-index procedure

Study Arms (1)

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)

Interventions

PTA (UltraScore Focused Force PTA Balloon) DEVICE

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.

PTA-UltraScore Focused Force PTA balloon

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
• 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.
• Subject must be willing to comply with the protocol requirements, including the follow-up procedures.
• 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.
• Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off.
• The target lesion must be able to be crossed using a guidewire (use of chronic total occlusion (CTO) or atherectomy is allowed).

You may not qualify if:

• Subjects that are to receive one or more stents as adjunctive therapy at the target lesion (bail out stenting is allowed).
• The subject has a single target lesion that involves both ATK and BTK arteries.
• The subject has a target lesion in a previously placed stent or stent graft (in-stent restenosis).
• The subject has a lesion, which in the opinion of the Investigator, would preclude safe use of the UltraScore™ Focused Force PTA balloon.
• The subject has a flow limiting dissection at the target lesion prior to use of the UltraScore™ Focused Force PTA balloon.
• The subject has acute limb ischemia.
• The subject has been assessed Rutherford category 6.
• The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (31)

St. Luke's Hospital- Phoenix

Phoenix, Arizona, 85006, United States

Location

Health One Denver Heart

Denver, Colorado, 80220, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

St. Joseph Hospital

Fort Wayne, Indiana, 46802, United States

Location

Community Hospital Munster Research Foundation

Munster, Indiana, 46321, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Willis Knighton Medical Center

Bossier City, Louisiana, 71112, United States

Location

CIS Clinical Research Corporation

Lafayette, Louisiana, 70506, United States

Location

MedStar Health Research Institute

Annapolis, Maryland, 21401, United States

Location

Beth Israel Deaconess Medical Center, Inc

Boston, Massachusetts, 02215, United States

Location

Providence-Providence Park Hospital

Southfield, Michigan, 48075, United States

Location

SSM DePaul Health Center

Bridgeton, Missouri, 63044, United States

Location

St. Louis Univeristy

St Louis, Missouri, 63103, United States

Location

Methodist Health System

Omaha, Nebraska, 68114, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

Rex Hospital, Inc

Raleigh, North Carolina, 27607, United States

Location

Coastal Surgery Specialists

Wilmington, North Carolina, 28401, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

US Cardiovascular Jefferson Hills

Jefferson Hills, Pennsylvania, 15025, United States

Location

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, 17043, United States

Location

Vascular Access Solutions

Orangeburg, South Carolina, 29118, United States

Location

Stern Cardiovascular Foundation, Inc

Germantown, Tennessee, 38138, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78746, United States

Location

Baylor St. Luke's Health College of Medicine

Houston, Texas, 77030, United States

Location

The Methodist Hospital Research Institute dba Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Texas Tech University Health Science Center/University Medical Center

Lubbock, Texas, 79430, United States

Location

HSHS St. Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Anna Lovas
• Organization: Becton, Dickinson, and Company

anna.lovas@bd.com

952-239-0548

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: March 28, 2018
• Primary Completion: October 29, 2020
• Study Completion: April 1, 2022
• Last Updated: March 28, 2024
• Results First Posted: March 28, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)