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