A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix® Drug Coated Balloon PTA Catheter for Treatment of Below-the-Knee (BTK) Arteries

Withdrawn

• Conditions: Stenosis - narrow or blocked bloodvessel; 10003216

• Registration Number: NL-OMON42884
• Lead Sponsor: utonix, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Male or non-pregnant, non-breastfeeding female *18 years of age;
2. Rutherford Clinical Category 3-5;
3. Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen;
4. Significant stenosis (*70%) or occlusion of one or more native artery(s) below the tibial plateau and above the tibiotalar joint appropriate for angioplasty per operator visual assessment;
5. Lesion(s) can be treated with available Lutonix® DCB device size matrix per current IFU; and
6. Target vessel(s) reconstitute(s) at or above the ankle with inline flow to at least one patent (<50% residual stenosis) inframalleolar outflow vessel (planned treatment below-the-ankle is not allowed).
NOTE: Outflow must be assessed AFTER pre-dilatation
NOTE: More than one artery allowed, but each target vessel MUST demonstrate inline inframalleolar outflow.

Exclusion Criteria

Patients will be excluded if ANY of the following conditions apply:
1. Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix BTK registry);
2. Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; or
3. Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety: Freedom from BTK MALE+POD at 30-days<br /><br>Freedom at 30-Days from the composite of all-cause death, above-ankle<br /><br>amputation or major reintervention, i.e. new bypass graft, jump/interposition<br /><br>graft revision, or thrombectomy/thrombolysis, of the index limb involving a<br /><br>below-the-knee artery.<br /><br>Efficacy: TLR at 6 months<br /><br>Defined as clinically-driven target lesion reintervention (TLR). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following will be reported:<br /><br>* Acute Device and Procedural success<br /><br>* Primary patency (freedom from total occlusion) at 6, 12 and 24 months<br /><br>* Freedom from clinically-driven TLR at 12 and 24 months<br /><br><br /><br>The following will be reported at 1, 6, 12 and 24 months:<br /><br>* Above-ankle amputation<br /><br>* Target vessel reintervention (TVR)<br /><br>* Unexpected device or drug-related adverse events<br /><br>* Reintervention for treatment of thrombosis of the target vessel(s)<br /><br>* Reintervention for embolization to its distal vasculature<br /><br>* Death (any cause)<br /><br><br /><br>The following endpoints will be assessed at 6 and 12 months:<br /><br>* Wound healing (healed or not; if not, improving, stagnant, worsening)<br /><br>* New or recurrent lesion (target limb)<br /><br>* Change in Rutherford Class (target limb)</p><br>