Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon
- Conditions
- Peripheral Arterial DiseasePeripheral Vascular DiseasesArterial Occlusive Diseases
- Interventions
- Device: PTA (UltraScore Focused Force PTA Balloon)
- Registration Number
- NCT03193619
- Lead Sponsor
- C. R. Bard
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PTA-UltraScore Focused Force PTA balloon 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.
- Primary Outcome Measures
Name Time Method Number of Participants That Achieve Optimal PTA Results 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).
Number of Participants With Technical Success of Use of UltraScore™ Focused Force PTA Balloon 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 Outcome Measures
Name Time Method Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects 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.
Number of Participants With Bail-out Stenting Due to Dissection 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.
Number of Participants That Did Not Have a Target Lesion Revascularization (TLR). 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
Number of Participants That Did Not Have a Major Amputation of the Target Limb 12 months post-index procedure Major amputation is defined as above the ankle amputation
Number of Participants That Had Improved Clinical Measures From Baseline (ABI) 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.
Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) 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
Trial Locations
- Locations (31)
SSM DePaul Health Center
🇺🇸Bridgeton, Missouri, United States
US Cardiovascular Jefferson Hills
🇺🇸Jefferson Hills, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
🇺🇸Wormleysburg, Pennsylvania, United States
The Methodist Hospital Research Institute dba Houston Methodist Research Institute
🇺🇸Houston, Texas, United States
St. Luke's Hospital- Phoenix
🇺🇸Phoenix, Arizona, United States
Health One Denver Heart
🇺🇸Denver, Colorado, United States
Community Hospital Munster Research Foundation
🇺🇸Munster, Indiana, United States
St. Joseph Hospital
🇺🇸Fort Wayne, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Providence-Providence Park Hospital
🇺🇸Southfield, Michigan, United States
St. Louis Univeristy
🇺🇸Saint Louis, Missouri, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Methodist Health System
🇺🇸Omaha, Nebraska, United States
Rex Hospital, Inc
🇺🇸Raleigh, North Carolina, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
Coastal Surgery Specialists
🇺🇸Wilmington, North Carolina, United States
Stern Cardiovascular Foundation, Inc
🇺🇸Germantown, Tennessee, United States
Cardiothoracic and Vascular Surgeons
🇺🇸Austin, Texas, United States
Baylor St. Luke's Health College of Medicine
🇺🇸Houston, Texas, United States
Texas Tech University Health Science Center/University Medical Center
🇺🇸Lubbock, Texas, United States
HSHS St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
CIS Clinical Research Corporation
🇺🇸Lafayette, Louisiana, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Willis Knighton Medical Center
🇺🇸Bossier City, Louisiana, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Vascular Access Solutions
🇺🇸Orangeburg, South Carolina, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
MedStar Health Research Institute
🇺🇸Annapolis, Maryland, United States
Beth Israel Deaconess Medical Center, Inc
🇺🇸Boston, Massachusetts, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States