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

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ClinicalTrials.gov Identifier: NCT03193619
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2017
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Tracking Information
First Submitted Date June 19, 2017
First Posted Date June 21, 2017
Last Update Posted Date September 6, 2019
Actual Study Start Date March 28, 2018
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2017)
  • 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).
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03193619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 14, 2018)
  • Rate of bail-out stenting due to dissection [ Time Frame: Index procedure (Day 0); approximate duration of procedure is 90 minutes. ]
    Rate of emergency artery stent placement for abrupt or threatened artery closure caused by arterial dissection immediately following index procedure.
  • 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
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: June 19, 2017)
  • 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.
  • 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
  • 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
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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).
Condition
  • Peripheral Arterial Disease
  • Peripheral Vascular Diseases
  • Arterial Occlusive Diseases
Intervention 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.

Study Groups/Cohorts 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.
Intervention: Device: PTA (UltraScore Focused Force PTA Balloon)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 19, 2017)
350
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03193619
Other Study ID Numbers BPV-16-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party C. R. Bard
Study Sponsor C. R. Bard
Collaborators Not Provided
Investigators
Principal Investigator: 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
PRS Account C. R. Bard
Verification Date September 2019