Trial Outcomes & Findings for Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (NCT NCT03216005)

Not applicable - Pre-assignment was not part of the protocol

Race and Ethnicity were not collected from any participant.

Change in reflux time (reported as % change) in the primary treated vessel from pre-procedure baseline compared to the 30-day follow-up

Rates (count) of participant with DVTs in the target vessel at the 30-day time point - analyzed for subjects that completed the 30-day follow-up visit

Rates (count) of participants with DVTs in the target vessel at the 90-day and 210-day follow-up assessed by follow-up imaging

Assessment of the reflux time in the primary treated vein segment. Change in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 90-day and 210-day follow-up visits were assessed; the outcome is reported as the % change in the reflux time from Baseline

Procedure technical success is defined as delivery of the system to the target vessel and formation of at least one mobile autogenous valve (as measured with intravascular ultrasound (IVUS) or venography following valve formation) without target vessel occlusion at the conclusion of the index procedure

Assessment of the average (mean) rVCSS at Baseline, 30D and 90D. A severity score is assigned to each of ten attributes of venous disease; a total severity score is calculated by summing the individual attribute scores. The score is a composite based on a rating score of none (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, the number of active ulcers (0, +1, +2, \>/=3), duration of ulcers (\<3 months, \>3 months but \<1 year, not healed for \>1 year), active ulcer size (diameter \<2cm, diameter 2-6cm, and diameter \>6cm), and use of compression therapy (not used (0), intermittent use of stockings (+1), wears stockings most days (+2), and full compliance (+3)). A higher total score would indicate a worse outcome (total score can range from 0 to 30); the outcome is reported as the average (mean) scores at Baseline, 30D and 90D.

Assessment of the average (mean) change in rVCSS at 30D and 90D compared to Baseline. A severity score is assigned to each of ten attributes of venous disease; a total severity score is calculated by summing the individual attribute scores. The score is a composite based on a rating score of none (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, the number of active ulcers (0, +1, +2, \>/=3), duration of ulcers (\<3 months, \>3 months but \<1 year, not healed for \>1 year), active ulcer size (diameter \<2cm, diameter 2-6cm, and diameter \>6cm), and use of compression therapy (not used (0), intermittent use of stockings (+1), wears stockings most days (+2), and full compliance (+3)). An increase in total score over time would indicate a worse outcome; the outcome is reported as the average (mean) numeric change in score at 30D and 90D compared to the Baseline score (for Baseline scores refer to outcome measure "Average Revised Venous Clinical Severity Score").

Assessment of the average (mean) Villalta Scale Score at Baseline, 30D, and 90D. The score is a composite of 11 items based on a rating score of absent (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, and presence or absence of venous ulcers. Based on the possible rating scores of 0-3 for each item, the possible scale range for the 11 items is 0-33, where a higher Villalta Scale Score indicates a worse outcome; the outcome is reported as the average (mean) scores at Baseline, 30D and 90D. A total Villalta score of 0-4 indicates no disease (negative for PTS); a score of 5-9 indicates mild disease; a score of 10-14 indicates moderate disease; and a score of 15 or greater indicates severe disease.

Assessment of average (mean) change in Villalta Scale Score at 30D and 90D compared to Baseline. The score is a composite of 11 items based on a rating score of absent (0), mild (+1), moderate (+2) and severe (+3) for symptoms and clinical signs, and presence or absence of venous ulcers. Based on the possible rating scores of 0-3 for each item, the possible scale range for the 11 items is 0-33, where a higher Villalta Scale Score indicates a worse outcome; the outcome is reported as the average numeric change in score at 30D and 90D compared to the Baseline score (for Baseline scores refer to outcome measure "Average Villalta Scale Score"). A total Villalta score of 0-4 indicates no disease (negative for PTS); a score of 5-9 indicates mild disease; a score of 10-14 indicates moderate disease; and a score of 15 or greater indicates severe disease.

Assessment of the average (mean) VEINES-QoL/Sym Score at Baseline, 30D, 90D and 210D. The VEINES instrument consists of 35 items in 2 categories that generate two (2) separate summary scores for symptoms (VEINES-Sym) and quality of life (VEINES-QoL). Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. The scoring varies based on the following scores on a scale: Q1 (1-5, higher score is better); Q2/Q3 (1-6, higher score is better); Q4 (0-3, higher score is better); Q5 (1-2, higher score is better); Q6 (1-5, higher score is better); Q7 (1-6, higher score is worse/reverse scored when totaling the summary scores); Q8 (1-6, higher score is better). VEINES-QoL/Sym scores can range from 0-100, where higher scores indicate better outcomes (higher quality of life and less severe symptoms). The calculated mean VEINES-QoL/Sym scores at 30D, 90D and 210D post-procedure are provided.

Assessment of the change in the median (min, max) VEINES-QoL/Sym Score at 30D, 90D and 210D compared to Baseline. The VEINES instrument consists of 35 items in 2 categories that generate two (2) separate summary scores for symptoms (VEINES-Sym) and quality of life (VEINES-QoL). Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. The scoring varies based on the following scores on a scale: Q1 (1-5, higher score is better); Q2/Q3 (1-6, higher score is better); Q4 (0-3, higher score is better); Q5 (1-2, higher score is better); Q6 (1-5, higher score is better); Q7 (1-6, higher score is worse/reverse scored when totaling the summary scores); Q8 (1-6, higher score is better). The outcome is reported as the change in median (min, max) score at 30D, 90D and 210D compared to the Baseline score (for Baseline scores refer to outcome measure "Average VEINES-QoL/Sym Score").