Clinical trial NCT03193619: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2017-06-21
Enrollment: 350
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Primary outcomes:
measure: Number of Participants That Achieve Optimal PTA Results
timeFrame: Index procedure (Day 0); approximate duration of procedure is 90 minutes.
measure: Number of Participants With Technical Success of Use of UltraScore™ Focused Force PTA Balloon
timeFrame: Index procedure (Day 0); approximate duration of procedure is 90 minutes.
Secondary outcomes:
measure: Number of Participants With Bail-out Stenting Due to Dissection
timeFrame: Index procedure (Day 0); approximate duration of procedure is 90 minutes.
measure: Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).
timeFrame: 30 days post-index procedure
measure: Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).
timeFrame: 6 months post-index procedure
measure: Number of Participants That Did Not Have a Target Lesion Revascularization (TLR).
timeFrame: 12 months post-index procedure
measure: Number of Participants That Did Not Have a Major Amputation of the Target Limb
timeFrame: 30 days post-index procedure
measure: Number of Participants That Did Not Have a Major Amputation of the Target Limb
timeFrame: 6 months post-index procedure
measure: Number of Participants That Did Not Have a Major Amputation of the Target Limb
timeFrame: 12 months post-index procedure
measure: Number of Participants That Had Improved Clinical Measures From Baseline (ABI)
timeFrame: 30 days post-index procedure
measure: Number of Participants That Had Improved Clinical Measures From Baseline (ABI)
timeFrame: 6 months post-index procedure
measure: Number of Participants That Had Improved Clinical Measures From Baseline (ABI)
timeFrame: 12 months post-index procedure
measure: Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)
timeFrame: 30 days post-index procedure
measure: Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)
timeFrame: 6 months post-index procedure
measure: Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification)
timeFrame: 12 months post-index procedure
measure: Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects
timeFrame: 30 days post-index procedure
measure: Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects
timeFrame: 6 months post-index procedure
measure: Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects
timeFrame: 12 months post-index procedure
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Luke's Hospital- Phoenix
state: Arizona
city: Denver
country: United States
facility: Health One Denver Heart
state: Colorado
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Fort Wayne
country: United States
facility: St. Joseph Hospital
state: Indiana
city: Munster
country: United States
facility: Community Hospital Munster Research Foundation
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Bossier City
country: United States
facility: Willis Knighton Medical Center
state: Louisiana
city: Lafayette
country: United States
facility: CIS Clinical Research Corporation
state: Louisiana
city: Annapolis
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Inc
state: Massachusetts
city: Southfield
country: United States
facility: Providence-Providence Park Hospital
state: Michigan
city: Bridgeton
country: United States
facility: SSM DePaul Health Center
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Univeristy
state: Missouri
city: Omaha
country: United States
facility: Methodist Health System
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Raleigh
country: United States
facility: Rex Hospital, Inc
state: North Carolina
city: Wilmington
country: United States
facility: Coastal Surgery Specialists
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Jefferson Hills
country: United States
facility: US Cardiovascular Jefferson Hills
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Orangeburg
country: United States
facility: Vascular Access Solutions
state: South Carolina
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation, Inc
state: Tennessee
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons
state: Texas
city: Houston
country: United States
facility: Baylor St. Luke's Health College of Medicine
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute dba Houston Methodist Research Institute
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Science Center/University Medical Center
state: Texas
city: Green Bay
country: United States
facility: HSHS St. Vincent Hospital
state: Wisconsin
Study officials:
affiliation: Cardiovascular Institute of the South (CIS) Clinical Research Corporation
name: Craig Walker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Robert Beasley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor St. Luke's College of Medicine
name: Miguel Montero, MD
role: PRINCIPAL_INVESTIGATOR
References: