Clinical trial NCT03038438: ABRE Clinical Study of the Abre Venous Self-expanding Stent System
Official title: A Multi-center, Non-randomized Study to Evaluate the Safety and Effectiveness of the Abre Venous Self-expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iliofemoral Venous Obstruction
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2017-01-31
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and effectiveness of the Abre venous self-expanding stent system for treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.


Eligibility criteria: Inclusion Criteria:

1. Patient is ≥ 18 and ≤ 80 years of age;
2. Patient has at least one of the following clinical manifestations (i.e. symptoms and/or signs) of venous disease in lower extremity:

   * CEAP score ≥ 3
   * Venous Clinical Severity Score pain score (VCSS) ≥2
   * Suspected deep vein thrombosis (DVT);
3. Patient is willing and capable of complying with specified follow-up evaluations at the specified times;
4. Patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Ethics Board.
5. Patient has diagnosis of non-malignant venous obstruction within the common iliac, external iliac, and/or common femoral vein. The proximal point of the obstruction may extend to the iliac venous confluence of the inferior vena cava and the distal point may be at or above the deep femoral vein. Diagnosis must be made based on objective imaging by using venography and/or intravascular ultrasound (IVUS);
6. Patient has an obstructive lesion defined as:

   * Occluded, or
   * ≥50% in diameter reduction on venography or IVUS, or
   * ≥50% area reduction on IVUS
7. Acute DVT patients should be treated with the Abre stent within 14 days after onset of symptoms. Patients with acute DVT must first undergo successful treatment of acute thrombus by catheter based techniques; successful treatment is defined as 30% or less residual thrombus by venogram, as determined by physician, no bleeding, no symptomatic pulmonary embolism (confirmed by imaging), and no renal compromise (renal compromise defined as GFR\>30). Patients with underlying obstructive lesions can then be included in the study within the same procedure;
8. Target vessel can accommodate a 9 French Sheath, from insertion site to target segment;
9. Exchangeable guidewire must cross target lesion(s) with successful predilation.

Exclusion Criteria:

1. Patient with DVT in the target limb of which the onset of symptoms is between 15 days and 6 months prior to planned treatment or patient has an acute DVT anywhere else than in the target vessel;
2. Patient has peripheral arterial disease causing symptoms in target limb;
3. Patient is pregnant, female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure;
4. Patient has a known or suspected systemic infection at the time of the index procedure;
5. Patient has a planned percutaneous or surgical intervention within 30 days prior or 30 days following index procedure, or a contralateral iliofemoral lesion requiring planned treatment within 12 months;
6. Patient requires femoral endovenectomy and patch venoplasty, greater saphenous vein ablation, and/or small saphenous vein stripping during the index procedure;
7. Patient has an active vasculitic inflammatory disorder (e.g. Behcet disease) predisposing the patient to thrombosis and requiring systemic corticosteroid therapy;
8. Patient has impaired renal function (GFR \< 30) or is on dialysis;
9. Patient has a platelet count \< 50,000 cells/mm3 or \> 1,000,000 cells/mm3 and/or a White Blood Cell count \< 3,000 cells/mm3 or \> 12,500 cells/mm3;
10. Patient has a history of bleeding diathesis or either a history or presence of heparin induced thrombocytopenia antibodies;
11. Patient has a known hypersensitivity or contraindication to antiplatelets or anticoagulation, nitinol, or a contrast sensitivity that cannot be adequately pre-medicated;
12. Patient has presence of other severe co-morbid conditions, which in the investigator's opinion may interfere with the patient's compliance with study visits and procedures, or may confound interpretation of study data (e.g. congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy \< 1 year);
13. Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures. Patient must be able to consent for themselves;
14. Patient is currently participating in another investigational drug or device study or observational competitive study.
15. Patient has a vena cava obstruction or lesion extending into the inferior vena cava (IVC), or the presence of bilateral iliofemoral venous lesions requiring planned treatment within 12 months;
16. Patient has significant venous bleeding, arterial dissection or other injury requiring additional percutaneous or surgical intervention prior to enrollment;
17. Patient has a previously placed stent in the ipsilateral venous vasculature;
18. Patient has disease that precludes safe advancement of the venous stent to the target lesion(s)

Primary outcomes:
measure: Primary Patency
timeFrame: 12 Months
measure: Composite Major Adverse Events
timeFrame: 30 Days
Secondary outcomes:
measure: Device Success
timeFrame: Index Procedure
measure: Lesion Success Obtained at Index Procedure
timeFrame: Index Procedure
measure: Index Procedure Success
timeFrame: 30 days
measure: Primary Patency
timeFrame: 24 Months, 36 Months
measure: Primary Assisted Patency
timeFrame: 12 Months, 24 Months, 36 Months
measure: Secondary Patency
timeFrame: 12 Months, 24 Months, 36 Months
measure: Stent Fracture
timeFrame: 30 Days, 12 Months, 24 Months, 36 Months
measure: Target Lesion Revascularization
timeFrame: 30 days, 6 months, 12 months, 24 months, 36 months
measure: Delayed Stent Migration
timeFrame: 12 Months, 24 Months, 36 Months
measure: Major Adverse Events
timeFrame: 6 Months, 12 Months, 24 Months, 36 Months
measure: Major Bleeding Related to Index Procedure
timeFrame: 30 Days, 6 Months, 12 Months, 24 Months, 36 Months
measure: Re-Hospitalization
timeFrame: 0-180, 181-360, 361-720, 721-1080 and 0-1080 days
measure: Villalta Score
timeFrame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
measure: Venous Clinical Severity Score (VCSS)
timeFrame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
measure: EuroQol-5 Dimension (EQ-5D) Score
timeFrame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
measure: Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score
timeFrame: Change from Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Other outcomes:
Locations:
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: Darien
country: United States
facility: The Vascular Experts
state: Connecticut
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Health System
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: McKinney
country: United States
facility: Cardiac Center of Texas
state: Texas
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Bellevue
country: United States
facility: Lake Washington Vascular, PLLC
state: Washington
city: Marseille
country: France
facility: Assistance Publique - Hôpitaux de Marseille - Hôpital Nord
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Arnsberg
country: Germany
facility: Klinikum Arnsberg, Karolinen Hospital
city: Galway
country: Ireland
facility: Galway University Hospitals - University Hospital Galway
city: Modena
country: Italy
facility: Hesperia Hospital
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust - University College London Hospitals
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital
Study officials:
affiliation: Carolinas Health Care System
name: Erin Murphy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Stephen Black, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murphy E, Gibson K, Sapoval M, Dexter DJ, Kolluri R, Razavi M, Black S. Pivotal Study Evaluating the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction. Circ Cardiovasc Interv. 2022 Feb;15(2):e010960. doi: 10.1161/CIRCINTERVENTIONS.121.010960. Epub 2022 Feb 2.