Peripheral Artery Disease
Conditions
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.
Interventions
DEVICELutonix 014 Drug Coated Balloon PTA Catheter
Drug Coated Balloon PTA Catheter for Treatment of Below-the-Knee (BTK) Arteries
Sponsors
C. R. Bard
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Instructions for Use (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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from major adverse limb related events below the knee and of perioperative death. | 30-days | 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. |
| Rate of Target Lesion Revascularization (TLR) | 6 months | Defined as clinically-driven target lesion reintervention. All re-interventions at the target limb are captured and adjudicated by a Clinical Events Committee. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Status of ischemic wounds at the target limb | 6 and 12 months | Ischemic wounds and their status during the follow-up period will be captured. |
| Primary patency of the target lesion | 6, 12 and 24 months | Primary Patency of the target vessel is defined as freedom from total occlusion. Primary patency is assessed by the investigators. |
| Freedom from clinically-driven Target Lesion Revascularization (TLR) | 12 and 24 months | All events leading to re-interventions at the target limb will be adjudicated by a Clinical Events Committee. |
| Rate of amputations above the ankle at the target limb | 1, 6, 12 and 24 months | All events leading to amputations at the target limb will be adjudicated by a Clinical Events Committee. |
| Rate of reintervention for embolization to its distal vasculature | 1, 6, 12 and 24 months | Atherothrombotic debris may occlude the artery downstream and cause distal embolization. |
| Rate of unexpected device or drug-related adverse events | 1, 6, 12 and 24 months | 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. |
| Rate of reintervention for treatment of thrombosis of the target vessel(s) | 1, 6, 12 and 24 months | Arteries may occlude from thrombosis |
| Rate of new or recurrent artery lesions at the target limb | 6 and 12 months | Artery lesions are captured as Adverse Events. |
| Change in Rutherford Class at the target limb | 6 and 12 months | The Rutherford class is captured from Baseline to study end. |
| Rate of Target vessel reintervention (TVR) | 1, 6, 12 and 24 months | All events leading to re-interventions at the target limb will be adjudicated by a Clinical Events Committee. |
| Rate of death | 1, 6, 12 and 24 months | All events leading to a patient's death will be adjudicated by a Clinical Events Committee. |
Countries
Austria, Belgium, France, Germany, Greece, Italy, Portugal, Saudi Arabia, Spain, Switzerland, United Kingdom
Outcome results
None listed