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

Medtronic Endovascular24 sites in 6 countries260 target enrollmentDecember 13, 2017

ConditionsIliofemoral Venous Obstruction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Iliofemoral Venous Obstruction
Sponsor: Medtronic Endovascular
Enrollment: 260
Locations: 24
Primary Endpoint: Primary Patency
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 13, 2017

End Date

January 28, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Endovascular

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is ≥ 18 and ≤ 80 years of age;
•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);
•Patient is willing and capable of complying with specified follow-up evaluations at the specified times;
•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.
•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);
•Patient has an obstructive lesion defined as:
•Occluded, or

Exclusion Criteria

•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;
•Patient has peripheral arterial disease causing symptoms in target limb;
•Patient is pregnant, female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure;
•Patient has a known or suspected systemic infection at the time of the index procedure;
•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;
•Patient requires femoral endovenectomy and patch venoplasty, greater saphenous vein ablation, and/or small saphenous vein stripping during the index procedure;
•Patient has an active vasculitic inflammatory disorder (e.g. Behcet disease) predisposing the patient to thrombosis and requiring systemic corticosteroid therapy;
•Patient has impaired renal function (GFR \< 30) or is on dialysis;
•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;
•Patient has a history of bleeding diathesis or either a history or presence of heparin induced thrombocytopenia antibodies;

Outcomes

Primary Outcomes

Primary Patency

Time Frame: 12 Months

Freedom from occlusion of the stented segment; Freedom from restenosis \>=50%; and Freedom from clinically-driven target lesion revascularization

Composite Major Adverse Events

Time Frame: 30 Days

The components of the Major Adverse Events include: All-cause death occurring post-procedure, clinically-significant pulmonary embolism, major bleeding complication, stent thrombosis, and stent migration

Secondary Outcomes

Delayed Stent Migration(12 Months, 24 Months, 36 Months)
Major Adverse Events(6 Months, 12 Months, 24 Months, 36 Months)
Re-Hospitalization(0-180, 181-360, 361-720, 721-1080 and 0-1080 days)
Villalta Score(Baseline to 6 Months, 12 Months, 24 Months, 36 Months)
EuroQol-5 Dimension (EQ-5D) Score(Baseline to 6 Months, 12 Months, 24 Months, 36 Months)
Device Success(Index Procedure)
Lesion Success Obtained at Index Procedure(Index Procedure)
Venous Clinical Severity Score (VCSS)(Baseline to 6 Months, 12 Months, 24 Months, 36 Months)
Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score(Change from Baseline to 6 Months, 12 Months, 24 Months, 36 Months)
Index Procedure Success(30 days)
Primary Assisted Patency(12 Months, 24 Months, 36 Months)
Secondary Patency(12 Months, 24 Months, 36 Months)
Target Lesion Revascularization(30 days, 6 months, 12 months, 24 months, 36 months)
Major Bleeding Related to Index Procedure(30 Days, 6 Months, 12 Months, 24 Months, 36 Months)
Primary Patency(24 Months, 36 Months)
Stent Fracture(30 Days, 12 Months, 24 Months, 36 Months)