Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries

Study Overview
=================
Brief Summary
-----------------
The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.

Detailed Description
-----------------
Patients will be treated according to hospital routine with anticipated visits 30 days, 6 months, 12months and 24 months after the index procedure. Data on Rutherford grade, wound healing, patency of the target lesion, concomitant antiplatelet medication and Adverse Events will be collected.

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

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Device: Lutonix 014 Drug Coated Balloon PTA Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant, non-breastfeeding female ≥18 years of age; Rutherford Clinical Category 3-5; Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen; 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; Lesion(s) can be treated with available Lutonix DCB device size matrix per current Instructions for Use (IFU); and 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: 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); Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; or Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Lutonix 014 Drug Coated Balloon PTA Catheter|Drug Coated Balloon PTA Catheter for Treatment of Below-the-Knee (BTK) Arteries|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from major adverse limb related events below the knee and of perioperative death. | Freedom from the composite of all-cause death, above-ankle amputation or major reintervention, i.e. new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis, of the index limb involving a below-the-knee artery. All these events will be adjudicated by a Clinical Events Committee. | 30-days | 
| Rate of Target Lesion Revascularization (TLR) | Defined as clinically-driven target lesion reintervention. All re-interventions at the target limb are captured and adjudicated by a Clinical Events Committee. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency of the target lesion | Primary Patency of the target vessel is defined as freedom from total occlusion. Primary patency is assessed by the investigators. | 6, 12 and 24 months | 
| Freedom from clinically-driven Target Lesion Revascularization (TLR) | All events leading to re-interventions at the target limb will be adjudicated by a Clinical Events Committee. | 12 and 24 months | 
| Rate of amputations above the ankle at the target limb | All events leading to amputations at the target limb will be adjudicated by a Clinical Events Committee. | 1, 6, 12 and 24 months | 
| Rate of Target vessel reintervention (TVR) | All events leading to re-interventions at the target limb will be adjudicated by a Clinical Events Committee. | 1, 6, 12 and 24 months | 
| Rate of unexpected device or drug-related adverse events | Unexpected device or drug-related adverse events are those events that are related to the device or drug, but are not listed in the potential adverse event section of the Instructions For Use. | 1, 6, 12 and 24 months | 
| Rate of reintervention for treatment of thrombosis of the target vessel(s) | Arteries may occlude from thrombosis | 1, 6, 12 and 24 months | 
| Rate of reintervention for embolization to its distal vasculature | Atherothrombotic debris may occlude the artery downstream and cause distal embolization. | 1, 6, 12 and 24 months | 
| Rate of death | All events leading to a patient's death will be adjudicated by a Clinical Events Committee. | 1, 6, 12 and 24 months | 
| Status of ischemic wounds at the target limb | Ischemic wounds and their status during the follow-up period will be captured. | 6 and 12 months | 
| Rate of new or recurrent artery lesions at the target limb | Artery lesions are captured as Adverse Events. | 6 and 12 months | 
| Change in Rutherford Class at the target limb | The Rutherford class is captured from Baseline to study end. | 6 and 12 months |