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Abre Clinical Study 12-month Data

Abre™ Venous Self-expanding Stent System
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Alert Indications, Safety, and Warnings

The Abre Study Difference

Pie chart showing diverse set of patients in primary indication, PTS, NIVL, aDVT

Diverse Set of Patients

Challenging Patient Population   44% 

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

ABRE Clinical Study Design    

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 locationll

 

    Common iliac vein

96.0% (192/200)

    External iliac vein

80.5% (161/200)

    Common femoral vein

44.0% (88/200)

Primary Effectiveness Endpoint 

The Primary Effectiveness Performance  Goal Was Exceeded¶ 

88% Primary patency  at 12 months*

98.6% NIVL 87.1% aDVT 79.8% PTS Primary patency by patient population

Primary Safety Endpoint    

The MAE Rate  of 2% Was Significantly Lower than the Performance Goal 

98% Freedom from  MAEs at 30 days#

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Secondary Endpoints

0% Stent Fracture at 12 Months**

0% Stent Migration at 12 Months††

100% Device Success‡‡

Quality of Life

Sustained and clinically meaningful improvements in quality of life (QoL) measures and venous functional assessment scores (Villalta and Venous Clinical Severity Scores) at 12 months compared to baseline (p < 0.001).

Villalta Results

Chart showing Villalta scores with PTS symptoms decreasing at 6 and 12 months

Villalta Score: Mean ± SE (n)

Day 0: 11.2 ± 0.4 (199)

6 Months: 4.7 ± 0.3 (191)

12 Months: 4.2 ± 0.4 (192)

p < 0.001

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.


VCSS Results

Chart showing VCSS scores with disease severity decreasing at 6 and 12 months

VCSS Score: Mean ± SE (n)

Day 0: 8.8 ± 0.3 (199)

6 Months: 4.7 ± 0.3 (191)

12 Months: 4.3 ± 0.3 (192)

p < 0.001

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 Quality of Life Results

Chart showing quality of life index improving at 6 and 12 months

EQ-5D Index: Mean ± SE (n)

Day 0: 0.66 ± 0.02 (200)

6 Months: 0.81 ± 0.01 (192)

12 Months: 0.80 ± 0.02 (192)

p < 0.001

EQ-5D is a generic QoL questionnaire that assesses the subject's 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, 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.

‡

Site data was used when venography core laboratory data was not available.

§

Data from IVUS.

||

Stent extended across the locations.

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%.

#

MAEs included all-cause death, clinically significant pulmonary embolism, 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.