Aspiration Thrombectomy Using the Symphony or Prodigy System

Freedom from major (above-ankle) unanticipated amputation of the index limb

Treated limb improvement at 30 days, defined as no unplanned intervention for breakthrough re-thrombosis and improvement in Villalta score relative to baseline.

Normal right ventricular function at 30 days follow-up, defined as tricuspid annular plane systolic excursion (TAPSE) >1.7cm , measured on transthoracic echocardiography (TTE) and independently adjudicated.

Freedom from major (above-ankle) amputation of the index limb

Freedom from major (above-ankle) amputation of the index limb

Major adverse cardiovascular events (MACE) rate

Major adverse cardiovascular events (MACE) rate

Major adverse cardiovascular events (MACE) rate

Target vessel patency assessed using change in ankle-brachial index

Target vessel patency assessed using change in ankle-brachial index

Target vessel patency assessed using change in ankle-brachial index

Target vessel patency assessed using change in Rutherford claudication grade

Target vessel patency assessed using change in Rutherford claudication grade

Target vessel patency assessed using change in Rutherford claudication grade

Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management

Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management

Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management

Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6)

Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6)

All-cause mortality

All-cause mortality

All-cause mortality

Technical success defined as complete or near complete (>75%) reduction in Marder score from baseline to immediately after the use of the device and prior to any use of adjunctive device, as independently adjudicated

Rate of Major Adverse Events (MAEs) as adjudicated by an independent medical monitor and defined as the occurrence of any of the following:

• Major bleeding
• Device-related mortality
• Device-related Serious Adverse Events (SAE)

Treated limb improvement at 90 days, defined as no unplanned intervention for re-thrombosis in patients who are compliant with prescribed medical management and improvement in Villalta score relative to baseline

Treated limb improvement at 180 days, defined as no unplanned intervention for re-thrombosis in patients who are compliant with prescribed medical management and improvement in Villalta score relative to baseline

Proportion of patients demonstrating decrease in Villalta score (A decrease in Villalta score reflects an improvement per the following scale: 0-4 - no disease; 5-9: mild disease; 10-14: moderate disease; 15 or > : severe disease)

Proportion of patients demonstrating decrease in Villalta score

Proportion of patients demonstrating decrease in Villalta score

Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure.

Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure.

Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure.

Quality of life and symptom severity assessment using the Venous Insufficiency Epidemiological and Economic Study (VEINES -QOL); higher scores indicate better quality of life/fewer symptoms

All-cause mortality

All-cause mortality

All-cause mortality

Change in pulmonary artery pressure

Normal tricuspid annular plane systolic excursion (TAPSE) - independently adjudicated

Right ventricle fractional area change (FAC) on TTE pre-procedure, 48 hours - independently adjudicated

Right ventricle fractional area change (FAC) on TTE pre-procedure, 30 days - independently adjudicated

Tricuspid annular peak systolic velocity (S') pre-procedure, 48 hours - independently adjudicated

Tricuspid annular peak systolic velocity (S') pre-procedure, 30 days - independently adjudicated

Rate of Major Adverse Events (MAEs) as adjudicated by an independent medical monitor and defined as the occurrence of any of the following:

• Major bleeding
• Device-related mortality
• Device-related Serious Adverse Events (SAE)

Right ventricle to left ventricle (RV/LV) ratio reduction from baseline

Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class

Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class

Pulmonary Embolism recurrence

Pulmonary Embolism recurrence

Pulmonary Embolism recurrence

Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire

Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire

Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire

All-cause mortality

All-cause mortality

All-cause mortality