Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease

Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4.

Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.

Major Adverse Events (MAE) composite defined as all-cause death, clinically-driven target vessel revascularization (CD-TVR), major target limb amputation, thrombosis at the target lesion site

Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure baseline.

Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class. Rutherford classification is a clinical staging system that is used to describe peripheral arterial disease.

Freedom from target limb amputation and increase in Rutherford class.

Duplex ultrasound measurement that measures the peak systolic velocity of blood (cm/sec) within a lesion divided by the peak velocity of blood (cm/sec) proximal to the lesion.

Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used.

EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'.

Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication.

Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment).

Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).

Procedural success is defined as obtainment of ≤30% residual stenosis by visual estimate (with or without stenting)

Clinical success is defined as procedural success without procedural complications (death, stroke, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)) prior to discharge.

Days of hospitalization from procedure through 12 month.