The ABRE study difference: complex and diverse set of patients

  • 47.5% categorized as PTS patients.
  • 35.8% of PTS patients presented with complete vein occlusion.
  • 44% of patients with stents extending below inguinal ligament.
  • 112.4 mm average lesion length.
This is a graphic showing the clinical presentation of ABRE study patients.

Quality of life and venous functional scores: EQ5D, VEINES, Villalta, VCSS

EQ5D index score

This chart shows the EQ5D index score through 36 months in the ABRE clinical study.

VEINES-QoL§

This chart shows the VEINES-QoL score through 36 months in the ABRE clinical study.

Villalta

This chart shows the Villalta score through 36 months in the ABRE clinical study.

VCSS

This chart shows the VCSS score through 36 months in the ABRE clinical study.

Primary patency#

36-month patency

81.6% 
overall

NIVL 97.1% 
aDVT 76.5% 
PTS 70.4%

24-month patency

86.2% 
overall

NIVL 98.6% 
aDVT 83.3% 
PTS 76.8%

12-month patency

93.2% 
overall

NIVL 98.6% 
aDVT 100% 
PTS 86.4%

Primary safety end point

98.0% freedom from MAEs at 30 days.

Complications
Cumulative incidence
(based on Kaplan-Meier estimate)
36 months (within 1,080 days)
N = 200 subjects
TLR 16.3% (32)
MAE 10.2% (20)
    All-cause death occurring post-procedure 1.5% (3)
    Clinically significant pulmonary embolism 2.1% (4)
    Major bleeding complication (post-procedure) 0.5% (1)
    Stent thrombosis 6.1% (12)
    Stent migration 0.0% (0)
Major bleeding related to index procedure 0.0% (0)

Secondary end points

  • 83.7% freedom from TLR at 36 months.††
  • 0.0% stent fracture at 36 months.‡‡
  • 0.0% delayed stent migration at 36 months.§§
This is an image of a woman kneeling down in a greenhouse, tending to plants.

Abre™ clinical study design

Purpose and indication

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, 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)

Thrombophilia

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)##

74.9 ± 16.8

% Diameter stenosis (mean ± SD)

62.8 ± 28.7

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)