ABRE clinical study 24-month data

The effectiveness and safety performance goals (PG) were met with statistical significance (p < 0.0001). The primary effectiveness PG was 75% and the primary safety PG for MAE rate was 12.5% based on the literature. The 30-day MAE rate was 2.0%.

Primary patency was 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, and freedom from clinically driven target lesion revascularization.

MAEs included all-cause death, clinically significant pulmonary embolism, post-procedural major bleeding complication, stent thrombosis, and stent migration. MAEs were adjudicated by a Clinical Events Committee, except stent thrombosis and stent migration, which were assessed by an imaging core laboratory.

Fracture or breakage of any portion of the stent verified by core lab via X-ray.

Position change of a venous stent > 1 cm from its original location at the conclusion of the index procedure, as determined with regard to a reference anatomic structure, as verified by core labs.

Device success: successful delivery and deployment of the Abre stent in the target lesion with successful removal of the delivery system.

Villalta score categorizes the severity of PTS (score > 5 diagnoses PTS; score > 14 categorizes severe PTS). Symptoms of PTS assessed by Villalta include pain, heaviness, clinical signs such as skin induration and redness, and presence of venous ulcers.

Venous Clinical Severity Score (VCSS) measures venous disease severity over time and in response to treatment. VCSS scores range from 0, indicating no disease, to 30, indicating severe disease.

EQ-5D is a generic QoL questionnaire that assesses the subjects’ health status on that day on a range of 0–1 (worst health to best health).

Primary effectiveness endpoint was primary patency at 12 months post-procedure, defined as meeting all of the following: freedom from occlusion and ≥ 50% restenosis of the stented segment of the target lesion and freedom from clinically driven target lesion revascularization.

Primary safety endpoint was MAEs within 30 days post-procedure, including all-cause death, clinically significant pulmonary embolism, major procedural bleeding complication, stent thrombosis, and stent migration. MAEs were adjudicated by a Clinical Events Committee, except stent thrombosis and stent migration, which were assessed by an imaging core laboratory.

Data from IVUS.

Site and core lab data were used.