Major adverse events were defined as procedural bleeding requiring transfusion, procedure- or device-related death, clinically driven target lesion reintervention, clinical migration, new symptomatic PE, or procedure-related perforation requiring open surgical repair or flow-limiting dissection of the target vessel.

The study protocol specified the analysis be based on the intent-to-treat population, which includes all 243 enrolled patients. Among the 243 enrolled patients, data for the primary safety endpoint were available for 240 patients. Therefore, because the number of analyzable patients exceeded the minimum sample size required for sufficient statistical power (n=218), the primary analysis was based on the analyzable population in accordance with the study protocol.

Primary quantitative patency was defined as a treated venous segment that retained (uninterrupted; intervention-free) an MLD (Minimum Lumen Diameter ) > 50% of the immediate post-procedure stented MLD as demonstrated by venography as determined by the core laboratory.

The study protocol specified the primary analysis be based on intent-to-treat population (n=243). Among the 243 enrolled patients, 189 patients had venographic primary patency outcome data available (i.e., post-procedure and 12-month venogram data). Therefore, the results presented are after the outcome was imputed multiple times by random sampling from the Bernoulli distribution based on outcomes for the analyzable patients (n=189) without covariate adjustment.

Venous Clinical Severity Score (VCSS) is a method of classifying venous disease severity based on 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulcer, size of active ulcer, and use of compression therapy), each scored on a scale from 0 (Absent) to 3 (Severe). The VCSS score is the sum of the scores for the individual descriptors, ranging from 0 to 30.

Mean change = (1-month score - Baseline Score)

All participants with baseline and 1-month Venous Clinical Severity Score (VCSS) available. Venous Clinical Severity Score (VCSS) were available for 233 patients at 1 month.

Venous Clinical Severity Score (VCSS) is a method of classifying venous disease severity based on 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulcer, size of active ulcer, and use of compression therapy), each scored on a scale from 0 (Absent) to 3 (Severe). The VCSS score is the sum of the scores for the individual descriptors, ranging from 0 to 30.

Mean change = (12-month score - Baseline Score)

All participants with baseline and 12-months Venous Clinical Severity Score (VCSS) available. Venous Clinical Severity Score (VCSS) were available for 202 patients at 12 months.