ABRE Clinical Study of the Abre Venous Self-expanding Stent System

NCT ID: NCT03038438

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-13
• Study Completion Date: 2022-01-28

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.

Conditions

Iliofemoral Venous Obstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abre

Abre Venous Self-expanding Stent System

Group Type: EXPERIMENTAL

Abre venous self-expanding stent system

Intervention Type: DEVICE

venous stent

Interventions

Abre venous self-expanding stent system

venous stent

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Carolinas Health Care System

Stephen Black, MD

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Locations

St. Joseph Hospital

Orange, California, United States

The Vascular Experts

Darien, Connecticut, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

Albany Medical Center

Albany, New York, United States

NYU Langone Medical Center

New York, New York, United States

The Mount Sinai Health System

New York, New York, United States

Stony Brook Medicine

Stony Brook, New York, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

NC Heart and Vascular Research

Raleigh, North Carolina, United States

OhioHealth Research Institute

Columbus, Ohio, United States

Cardiac Center of Texas

McKinney, Texas, United States

Sentara Vascular Specialists

Norfolk, Virginia, United States

Lake Washington Vascular, PLLC

Bellevue, Washington, United States

Assistance Publique - Hôpitaux de Marseille - Hôpital Nord

Marseille, , France

Hôpital Européen Georges Pompidou

Paris, , France

Universitätsklinikum Aachen

Aachen, , Germany

Klinikum Arnsberg, Karolinen Hospital

Arnsberg, , Germany

Galway University Hospitals - University Hospital Galway

Galway, , Ireland

Hesperia Hospital

Modena, , Italy

University College London Hospitals NHS Foundation Trust - University College London Hospitals

London, , United Kingdom

Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital

London, , United Kingdom

Countries

United States; France; Germany; Ireland; Italy; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35105153 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

APV-ABRE

Identifier Type: -

Identifier Source: org_study_id