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Completed

NCT Number: NCT03193619

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

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Luke's Hospital- Phoenix, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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

    • 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. 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

    • 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

  13. 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

    • 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

  14. 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.

  15. 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.

  16. 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.

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jun 21, 2017
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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