|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P200026 / PAS001 |
| Date Original Protocol Accepted |
10/21/2020
|
| Date Current Protocol Accepted |
|
| Study Name |
ABRE Continued Follow-up Study
|
| Device Name |
Abre Venous Self-expanding Stent System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
To evaluate the long-term safety and effectiveness of the ABRE Stent System for treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease through 36 months.
A prospective, multi-center, follow-up of the ABRE pivotal study
|
| Study Population |
Subjects between 18 and 80 years (inclusive) requiring treatment of a non-malignant venous obstruction within the common iliac, external iliac
and/or common femoral vein enrolled in the ABRE Study.
Subjects were categorized as acute DVT (aDVT), post-thrombotic syndrome (PTS), or non-thrombotic iliac vein lesion (NIVL)).
|
| Sample Size |
A total of 200 subjects were enrolled at 24 sites in the U.S. and Europe, 128 (64%) of subjects enrolled at US sites and 72 (36%) subjects at
European sites.
|
| Key Study Endpoints |
Primary Endpoint
Freedom from target lesion revascularization (TLR) at 36 months.
Secondary Endpoints
The following secondary endpoints will be evaluated annually through 36 months post implant:
Primary patency
Primary assisted patency
Secondary patency
Target Lesion Revascularization (TLR)
Major Adverse Events (MAE)
Delayed Stent Migration
Stent Fracture
Change in VEINES-QOL/Sym Score
Change in VILLALTA Score
Change in EQ5D Quality of life Score
Change in VCSS Score
Major bleeding complication
Medical resource utilization
|
| Follow-up Visits and Length of Follow-up |
36 months
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
200
|
| Actual Number of Sites Enrolled |
24
|
| Patient Follow-up Rate |
98.9%
|
| Final Safety Findings |
Through 1080 days a total of 414 adverse events (non-SAEs) were reported in 144 subjects. Musculoskeletal and connective tissue disorders (23.5%), Vascular Disorders (19.0%), General disorders and administration site conditions (17.5%), and Infections and Infestations (17.0%) were the most reported non-SAE SOCs. Subjects with aDVT mostly reported general disorders and administration site conditions with 24.2%, while 27.4% of subject with PTS reported musculoskeletal and connective tissue disorders, and 25.0% of subjects with NIVL reported vascular disorders.
|
| Final Effect Findings |
The 36-month primary patency rate was 80.6%. Among the subjects evaluable for primary patency, the freedom from occlusion rate at 36 months was 98.5%, the freedom from restenosis rate at 36 months was 90.4%, and the freedom from clinically driven TLR through 1110 days was 85.9%. The primary assisted patency rate at 36 months was 86.4%. The secondary patency rate at 36 months was 90.4%.
|
| Study Strengths & Weaknesses |
Study strength: good follow up rates were achieved. Weakness: The study was a single-arm study without a control arm.
|
| Recommendations for Labeling Changes |
Yes
|
