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

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.

Study Overview

• Status: Completed
• Conditions: Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Bail-out Stenting Due to Dissection	Number of participants who needed stent placement for abrupt or threatened artery closure caused by arterial dissection immediately following index procedure.	Index procedure (Day 0); approximate duration of procedure is 90 minutes.
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).	TLR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in target vessel after the index procedure	30 days post-index procedure
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).	TLR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in target vessel after the index procedure	6 months post-index procedure
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).	TLR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in target vessel after the index procedure	12 months post-index procedure
Number of Participants That Did Not Have a Major Amputation of the Target Limb	Major amputation is defined as above the ankle amputation	30 days post-index procedure
Number of Participants That Did Not Have a Major Amputation of the Target Limb	Major amputation is defined as above the ankle amputation	6 months post-index procedure
Number of Participants That Did Not Have a Major Amputation of the Target Limb	Major amputation is defined as above the ankle amputation	12 months post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)	Resting ankle brachial index (ABI) for chronic limb ischemia measurements will be assessed clinically at follow-up and compared with baseline. ABI measurements: Mild to moderate if the ABI is between 0.4 and 0.9, and an ABI less than 0.40 is suggestive of severe PAD [19]. An ABI value greater than 1.3 is also considered abnormal, suggestive of non-compressible vessels.	30 days post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)	Resting ankle brachial index (ABI) for chronic limb ischemia measurements will be assessed clinically at follow-up and compared with baseline. ABI measurements: Mild to moderate if the ABI is between 0.4 and 0.9, and an ABI less than 0.40 is suggestive of severe PAD [19]. An ABI value greater than 1.3 is also considered abnormal, suggestive of non-compressible vessels.	6 months post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (ABI)	Resting ankle brachial index (ABI) for chronic limb ischemia measurements will be assessed clinically at follow-up and compared with baseline. ABI measurements: Mild to moderate if the ABI is between 0.4 and 0.9, and an ABI less than 0.40 is suggestive of severe PAD [19]. An ABI value greater than 1.3 is also considered abnormal, suggestive of non-compressible vessels.	12 months post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)	Rutherford classification (RC): 0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain; Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after >2 blocks (>600 feet, or 2 football fields); Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields); Severe claudication: ischemic limb muscle pain that limits walking to <1 block (<300 feet, or 1 football field); Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion; Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia; Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts	30 days post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)	Rutherford classification (RC): 0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain; Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after >2 blocks (>600 feet, or 2 football fields); Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields); Severe claudication: ischemic limb muscle pain that limits walking to <1 block (<300 feet, or 1 football field); Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion; Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia; Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts	6 months post-index procedure
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)	Rutherford classification (RC): 0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain; Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after >2 blocks (>600 feet, or 2 football fields); Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields); Severe claudication: ischemic limb muscle pain that limits walking to <1 block (<300 feet, or 1 football field); Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion; Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia; Major tissue loss: ischemic gangrene extending above TM level, functional foot no longer salvageable without extensive resvascularization efforts	12 months post-index procedure
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects	ATK subjects have a target lesion of the SFA or popliteal artery only. Primary patency (patent or open target vessel) is measured by duplex ultrasound (DUS) core lab; the core lab determines whether target vessel is patent/open.	30 days post-index procedure
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects	ATK subjects have a target lesion of the SFA or popliteal artery only. Primary patency (patent or open target vessel) is measured by duplex ultrasound (DUS) core lab; the core lab determines whether target vessel is patent/open.	6 months post-index procedure
Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects	ATK subjects have a target lesion of the SFA or popliteal artery only. Primary patency (patent or open target vessel) is measured by duplex ultrasound (DUS) core lab; the core lab determines whether target vessel is patent/open.	12 months post-index procedure

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Craig Walker, MD, Cardiovascular Institute of the South (CIS) Clinical Research Corporation; Principal Investigator: Miguel Montero, MD, Baylor St. Luke's College of Medicine; Principal Investigator: Robert Beasley, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): October 29, 2020
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: BPV-16-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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