Trial Outcomes & Findings for ABRE Clinical Study of the Abre Venous Self-expanding Stent System (NCT NCT03038438)

Patients were screened for enrollment based on the study Inclusion/Exclusion criteria between December 2017 and November 2018. Included subjects went on to have one or more Abre stents implanted. The first subject was included on December 19, 2017 and the last subject was included on November 29, 2018.

Of the 260 enrolled subjects, 200 met inclusion criteria and were implanted with the Abre stent(s).

ABRE Clinical Study of the Abre Venous Self-expanding Stent System

Freedom from occlusion of the stented segment; Freedom from restenosis \>=50%; and Freedom from clinically-driven target lesion revascularization

The components of the Major Adverse Events include: All-cause death occurring post-procedure, clinically-significant pulmonary embolism, major bleeding complication, stent thrombosis, and stent migration

Successful delivery and deployment of the stent and removal of the delivery system during the index procedure. Stent based outcome measure.

Venographic evidence of \<50% residual stenosis of the stented segment of the target lesion after post-dilation.

Lesion success without procedure-related MAEs prior to hospital discharge

Primary Patency: Defined as meeting all of the following criteria: * Freedom from occlusion of the stented segment of the target lesion; * Freedom from restenosis ≥50% of the stented segment of the target lesion; * Freedom from clinically driven target lesion revascularization.

Uninterrupted patency of the stented segment of the target lesion with a secondary intervention, also known as an adjunctive treatment (e.g. balloon venoplasty, subsequent stenting, etc.)

Secondary patency is defined as patency of the stented segment of the target lesion after subsequent intervention for an occlusion.

X-ray for the 30-day visit was only required on the first 30 subjects. Stent Fracture within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1080, respectively.

Percentage of subjects with target lesion revascularization through 30 days, 180 days, 360 days, 720, and 1080 days.

Delayed Stent Migration within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1140, respectively.

Safety endpoints (MAE, TLR, and Major Bleeding) included subjects with an event or without an event but follow-up days have reached 150 days for 6-month, 330 days for 12-month, 690 days for 24-month, and 1050 days for 36-month visit.

A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more post-index procedure is related to bleeding occurring during the index procedure.

Number of subjects that were re-hospitalized due to their target lesion from the Index Procedure.

Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS. Change in Villalta scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months). A negative change is associated with improved outcome.

VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Follow-up score minus the Baseline score. A negative change is associated with improved outcome.

Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health). A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, and 24 months) for both the index and VAS scores.

Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym). Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months). A positive change is associated with improved outcome.