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

C. R. Bard

Status

Completed

Conditions

Peripheral Vascular Diseases

Arterial Occlusive Diseases

Peripheral Arterial Disease

Treatments

Device: PTA (UltraScore Focused Force PTA Balloon)

Study type

Observational

Funder types

Industry

Identifiers

NCT03193619

BPV-16-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

350 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.