Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis

Primary Safety Events include: All Cause Perioperative (≤30 day) Death, Index Limb Amputation, Index Limb Reintervention and Index Limb Related Death at 1 Year

Time frame: 12 Months

Population: All participants with 12-month evaluable data for the primary safety endpoint.

Primary patency is defined as freedom from clinically driven target lesion restenosis (TLR) and from Binary Restenosis.

Time frame: 12 Months

Population: All subjects who completed a 12-Month follow-up visit

EQ-5D is a standardized tool to assess patient-reported mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, or slight, moderate, severe, or extreme problems. Patients choose the appropriate level in each of the 5 dimensions, which results in a 1-digit number for each dimension. The digits for the 5 dimensions are converted into a single EQ-5D™ index score based on a set of population-based preference weights. For the U.S. general population, possible EQ-5D™ index scores range from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. A downloadable scoring file is available at: https://www.ahrq.gov/rice/EQ5Dscore.htm. The EQ VAS records a patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). A higher VAS value indicates a higher quality of life.

Time frame: 6 months and 12 Months

Population: All participants with evaluable data

The Walking Impairment Questionnaire (WIQ) is a validated questionnaire that evaluates walking ability with a focus on walking distance, walking speed, and the ability to climb stairs. Participants answer each item on a Likert scale from 0 for unable to do to 4 for no difficulty, and each response is weighted based on the difficulty of the task. The overall score is determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100. The overall score ranges from 0-100 with lower scores indicating lower performance.

Time frame: 6 months and 12 months

Population: All participants with evaluable data

The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium).

Time frame: 6 months and 12 months

Population: All participants with evaluable data

The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene. A decrease in units on the scale represents improvement in clinical symptoms.

Time frame: 6 months and 12 months

Population: All patients with evaluable data.

Device success is defined as, on a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.

Time frame: During the Index Procedure (90 mins)

Population: All participants with evaluable data

Mortality from any cause.

Time frame: 1 month, 6 months, and 12 months

Population: All participants with evaluable data

Any surgical intervention in the target limb.

Time frame: 1 month, 6 months, and 12 months

Population: All participants with evaluable data

Clinically-driven TLR is defined as revascularization of the target vessel with evidence of target vessel diameter stenosis \>50% determined by duplex ultrasound or angiography and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated with the target limb or due to clinical symptoms), OR revascularization of a target vessel with an in-lesion diameter stenosis of \>70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms.

Time frame: 6 months and 12 months

Population: All participants with evaluable data.

Major limb amputation is defined as amputation of the lower limb above the ankle.

Time frame: 1 month, 6 months, and 12 months

Population: All participants with evaluable data

Freedom from major vascular complications at 30 days follow-up

Time frame: 30 Days

Population: All participants with evaluable data

Minor limb amputation is defined as amputation of a part of the foot below the ankle.

Time frame: 1 month, 6 months, and 12 months

Population: All participants with evaluable data

TLR is defined as any repeat revascularization procedure (percutaneous or surgical) of the original target lesion site.

Time frame: 6 months and 12 months

Population: All participants with evaluable data.

A TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel.

Time frame: 1 month, 6 months, and 12 months

Population: All participants with evaluable data

Primary Patency is defined as Freedom from CEC-adjudicated Clinically-Driven TLR and from Core laboratory-adjudicated Binary Restenosis. Binary restenosis is based on threshold Doppler peak systolic velocity ratio (PSVR) ≥ 2.5 (together with waveform analysis & color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol).

Time frame: 6 months and 12 months

Population: All participants with evaluable data at each time point.

Procedural Success is defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without major adverse events (defined as occurrence of death, amputation of the target limb, or repeat revascularization of the target lesion) during the index procedure and through the hospital stay.

Time frame: During the Index Procedure (90 mins)

Population: All participants with evaluable data.

Secondary patency is defined as the absence of Binary Restenosis as adjudicated by the blinded, independent core laboratory, independent of whether or not patency is re-established via an endovascular procedure.

Time frame: 6 months and 12 months

Population: All participants with evaluable data.

Sustained clinical benefit is defined as an improvement in Rutherford Classification compared to baseline and freedom from target vessel revascularization. The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene. A decrease in units on the scale represents improvement in clinical symptoms.

Time frame: 6 months and 12 months

Population: All participants with evaluable data

Technical success of the balloon procedure is defined as the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion and a successful withdrawal of the study system with the achievement of \< 30% residual percent stenosis without deployment of a bail-out stent.

Time frame: During the Index Procedure (90 mins)