N/A
Completed N=350
Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon
Peripheral arterial disease · Peripheral Vascular Diseases · Arterial Occlusive Diseases
Source: ClinicalTrials.gov NCT03193619 ↗
Enrolled (actual)
350
Serious AEs
12.9%
Results posted
Mar 2024
Primary outcomePrimary: Number of Participants That Achieve Optimal PTA Results — 254 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Achieve Optimal PTA Results |
254 | — |
| PRIMARY Number of Participants With Technical Success of Use of UltraScore™ Focused Force PTA Balloon |
350 | — |
| SECONDARY Number of Participants With Bail-out Stenting Due to Dissection |
14 | — |
| SECONDARY Number of Participants That Did Not Have a Target Lesion Revascularization (TLR). |
232 | — |
| SECONDARY Number of Participants That Did Not Have a Major Amputation of the Target Limb |
253 | — |
| SECONDARY Number of Participants That Had Improved Clinical Measures From Baseline (ABI) |
0.952 | — |
| SECONDARY Number of Participants That Had Improved Clinical Measures From Baseline (Rutherford Classification) |
112; 30; 22; 23; 12; 12 | — |
| SECONDARY Number of Participants That Had an Open (Patent) Target Vessel for Above the Knee (ATK) Subjects |
64 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03193619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.