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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03038438
Recruitment Status : Active, not recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

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.

Condition or disease Intervention/treatment Phase
Iliofemoral Venous Obstruction Device: Abre venous self-expanding stent system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 13, 2017
Actual Primary Completion Date : January 14, 2020
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Experimental: Abre
Abre Venous Self-expanding Stent System
Device: Abre venous self-expanding stent system
venous stent




Primary Outcome Measures :
  1. 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

  2. Incidence of 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 stent migration



Secondary Outcome Measures :
  1. Successful delivery and deployment of the stent and removal of the delivery system during the index procedure [ Time Frame: Index Procedure ]
  2. Lesion Success obtained at Index Procedure [ Time Frame: Index Procedure ]
    Venographic evidence of <50% residual stenosis of the stented segment of the target lesion after post-dilation.

  3. Index Procedure Success [ Time Frame: 30 Days ]
    Lesion success without procedure-related MAEs prior to hospital discharge

  4. Percentage of subjects with primary assisted patency at 12 months [ Time Frame: 12 months ]
    primary assisted patency is defined as uninterrupted patency of the stented segment of the target lesion with a secondary intervention.

  5. Percentage of subjects with secondary patency at 12 months [ Time Frame: 12 months ]
    Secondary patency is defined as patency of the stented segment of the target lesion after subsequent intervention for an occlusion.

  6. Rate of Target Lesion Revascularization through 30 days, 6-, 12-, 24-, and 36 months [ Time Frame: 36 months ]
  7. Major Adverse Events through 30 days, 6-, 12-, 24-, and 36 months [ Time Frame: 36 months ]
  8. Rate of Delayed Stent Migration at 12-, 24-, and 36 months [ Time Frame: 36 months ]
  9. Rate of Stent Fracture at 30 days, 12-, 24-, and 36 months [ Time Frame: 36 months ]
  10. Change in Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms QOL/Sym Score at 6-, 12-, 24-, and 36 months [ Time Frame: 36 months ]
    Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES QOL/Sym) has a mean T-score of 50 and results can only be compared over time, no single point in time score is reported. Higher scores correlate to better quality of life.

  11. Change in Villalta score at 6-, 12-, 24-, and 36 months compared to baseline [ Time Frame: 36 months ]
    Villalta scores categorize the severity of post-thrombotic syndrome (PTS). A score >5 diagnoses PTS, a score >14 categorizes severe PTS

  12. Change in EuroQol-5 Dimension (EQ-5D) Score at 6-, 12-, 24-, and 36 months compared to baseline [ Time Frame: 36 months ]
    Higher score indicates a worse quality of life. The questionnaire contains five dimensions where score rank from 1 (best) to 5 (worst) plus a visual analog scale (0 = worst health; 100 = best health).

  13. Change in venous clinical severity score (VCSS) at 6-, 12-, 24-, and 36 months compared to baseline [ Time Frame: 36 months ]
    VCSS scores range from 0=no disease to 30=severe disease

  14. Major Bleeding Complication at 30 days, 6-, 12-, 24-, and 36 months [ Time Frame: 36 months ]
  15. Duration of hospital stay for Index procedure and Rate of subject re-hospitalization through 36 months [ Time Frame: 36 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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:

    i. Occluded, or ii. ≥50% in diameter reduction on venography or IVUS, or iii. ≥50% area reduction on IVUS

  • 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.
  • Target vessel can accommodate a 9 French Sheath, from insertion site to target segment;
  • Exchangeable guidewire must cross target lesion(s) with successful predilation.

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;
  • Patient has a known hypersensitivity or contraindication to antiplatelets or anticoagulation, nitinol, or a contrast sensitivity that cannot be adequately pre-medicated;
  • 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);
  • 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;
  • Patient is currently participating in another investigational drug or device study or observational competitive study.
  • 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;
  • Patient has significant venous bleeding, arterial dissection or other injury requiring additional percutaneous or surgical intervention prior to enrollment;
  • Patient has a previously placed stent in the ipsilateral venous vasculature;
  • Patient has disease that precludes safe advancement of the venous stent to the target lesion(s)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038438


Locations
Show Show 24 study locations
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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Principal Investigator: Erin Murphy, MD Carolinas Health Care System

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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT03038438    
Other Study ID Numbers: APV-ABRE
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes