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ABRE clinical study 24-month data

Abre™ Venous Self-expanding Stent System
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The ABRE study difference

Challenging patient population

44% of subjects (88/200) had stents that extended below the inguinal ligament into the common femoral vein (CFV).

Site and core lab data were used.

Diverse set of patients

  • 47.5% post-thrombotic syndrome (PTS)
  • 36% nonthrombotic iliac vein lesion (NIVL)
  • 16.5% acute DVT (aDVT)
Pie chart showing diverse set of patients in primary indication, PTS, NIVL, aDVT

Primary effectiveness endpoint

The primary effectiveness performance goal was met.*

12 months

  • 88% primary patency at 12 months
  • 98.6% NIVL, 87.1% aDVT, 79.8% PTS primary patency by patient population

24 months

  • 85.7% primary patency at 24 months
  • 24-month patency by patient population not yet available due to COVID-19 follow-up challenges

Primary safety endpoint

The MAE rate of 2% was met.*

  • 98% freedom from MAEs at 30 days

Secondary endpoint

  • 0% stent fractures at 24 months§
  • 0% stent migration at 24 months||
  • 100% device success

Quality of life

Clinically meaningful improvements in quality of life and venous functional assessment scores through 24 months compared to baseline.

Quality of life measures

Chart showing quality of life scores at 24 months in ABRE clinical study

ABRE clinical study design

ABRE clinical study design

Purpose

Evaluate the safety and effectiveness of the Abre venous self-expanding stent system, intended for the treatment of symptomatic iliofemoral venous outflow obstruction

Sample size

200 subjects

Initial clinical presentation

Acute DVT (aDVT), post-thrombotic syndrome (PTS), and nonthrombotic iliac vein lesion (NIVL)

Follow-up

1, 6, 12, 24, and 36 months

Study design

    • Prospective, multicenter, single-arm
    • Designed to meet literature-based performance goals:
      • 12-month primary effectiveness endpoint‡‡
      • 30-day primary safety endpoint§§

Baseline demographics 

Demographics

Included subjects

Age (years) (mean ± SD)

51.5 ± 15.9 

Age (< 50 years) 41.5% (83/200)
Female

66.5% (133/200)

BMI (kg/m²) (mean ± SD)

29.5 ± 7.1 

Baseline medical history

Medical history

Included subjects

Previous history of venous thromboembolism

52.0% (104/200)

Hypertension

31.0% (62/200)

Venous claudication

30.0% (60/200)

Known family history of DVT

22.0% (44/200)

Pulmonary embolism

17.0% (34/200)

Smoking (active)

12.0% (24/200)

Hypercoagulable condition

11.5% (23/200)

Cancer (ongoing or remission)

11.0% (22/200)

IVC filter present

5.0% (10/200)

Procedural data

Assessment

Included subjects

Target limb — left

92% (184/200)

Reference vessel diameter (mm) (mean ± SD)

15.0 ± 2.7

% area stenosis (mean ± SD)llll

74.9 ± 16.8

% diameter stenosis (mean ± SD)

63.0 ± 28.6

Subjects with occluded lesions

25.6% (50/195)

Lesion length (mm) (mean ± SD)  

112.4 ± 66.1

Total stented length (mm) (mean ± SD)

134.3 ± 58.0

Number of Abre stents implanted per subject

1.5 ± 0.6 

Stented vein location¶¶

 

    Common iliac vein

96.0% (192/200)

    External iliac vein

80.5% (161/200)

    Common femoral vein

44.0% (88/200)

Additional resources

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*

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.

Reference

ABRE CSR v1.2 30/JUL/2020 and ABRE 24M PASR v1.0.