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

October 4, 2023 updated by: C. R. Bard

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants That 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).
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
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.
Index procedure (Day 0); approximate duration of procedure is 90 minutes.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Bail-out Stenting Due to Dissection
Time Frame: Index procedure (Day 0); approximate duration of procedure is 90 minutes.
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).
Time Frame: 30 days post-index procedure
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).
Time Frame: 6 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
6 months post-index procedure
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).
Time Frame: 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
12 months post-index procedure
Number of Participants That Did Not Have a Major Amputation of the Target Limb
Time Frame: 30 days post-index procedure
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
Time Frame: 6 months post-index procedure
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
Time Frame: 12 months post-index procedure
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)
Time Frame: 30 days post-index procedure
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)
Time Frame: 6 months post-index procedure
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)
Time Frame: 12 months post-index procedure
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)
Time Frame: 30 days post-index procedure

Rutherford classification (RC):

0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain

  1. Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after >2 blocks (>600 feet, or 2 football fields)
  2. Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields)
  3. Severe claudication: ischemic limb muscle pain that limits walking to <1 block (<300 feet, or 1 football field)
  4. Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion
  5. Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia
  6. 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)
Time Frame: 6 months post-index procedure

Rutherford classification (RC):

0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain

  1. Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after >2 blocks (>600 feet, or 2 football fields)
  2. Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields)
  3. Severe claudication: ischemic limb muscle pain that limits walking to <1 block (<300 feet, or 1 football field)
  4. Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion
  5. Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia
  6. 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)
Time Frame: 12 months post-index procedure

Rutherford classification (RC):

0 Asymptomatic: documented peripheral arterial disease, without symptoms of claudication or ischemic pain

  1. Mild claudication: ischemic limb muscle pain that does not limit walking, or limits walking only after >2 blocks (>600 feet, or 2 football fields)
  2. Moderate claudication: ischemic limb muscle pain that limits walking to 1-2 blocks (300-600 feet, or 1-2 football fields)
  3. Severe claudication: ischemic limb muscle pain that limits walking to <1 block (<300 feet, or 1 football field)
  4. Ischemic rest pain: pain in the distal foot at rest felt to be due to limited arterial perfusion
  5. Minor tissue loss: non-healing ischemic ulcer(s) on distal leg, or focal gangrene with diffuse pedal ischemia
  6. 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
Time Frame: 30 days post-index procedure
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
Time Frame: 6 months post-index procedure
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
Time Frame: 12 months post-index procedure
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
C. R. Bard

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

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Locations

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