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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
Results First Posted : March 8, 2021
Last Update Posted : March 8, 2021
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 : 260 participants
Allocation: N/A
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. Percentage of Participants With 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. Percentage of Participants With 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 Outcome Measures :
  1. Device Success [ Time Frame: Index Procedure ]
    Successful delivery and deployment of the stent and removal of the delivery system during the index procedure. Stent based outcome measure.

  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. 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. 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. Target Lesion Revascularization Through 30 Days, 6-, 12 Months [ Time Frame: 30 days, 6 months, and 12 months ]
  7. Target Lesion Revascularization Through 24 Months [ Time Frame: 24 Month ]
  8. Target Lesion Revascularization Through 36 Months [ Time Frame: 36 Month ]
  9. Major Adverse Events Through 30 Days, 6-, 12 Months [ Time Frame: 30 days, 6 months, and 12 months ]
  10. Major Adverse Events Through 24 Months [ Time Frame: 24 Month ]
  11. Major Adverse Events Through 36 Months [ Time Frame: 36 Month ]
  12. Delayed Stent Migration at 12 Months [ Time Frame: 12 months ]
  13. Delayed Stent Migration at 24 Months [ Time Frame: 24 Month ]
  14. Delayed Stent Migration at 36 Months [ Time Frame: 36 Month ]
  15. Stent Fracture at 30 Days, 12 Months [ Time Frame: 30 days (30 subjects) and 12 months ]
  16. Stent Fracture at 24 Months [ Time Frame: 24 Month ]
  17. Stent Fracture at 36 Months [ Time Frame: 36 Month ]
  18. Change in Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms QOL/Sym Score at 6-, 12 Months [ Time Frame: Baseline to 6 and 12 months ]
    Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES QOL/Sym). Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Baseline score minus the Follow-up score (6 or 12 months). A positive change is associated with improved outcome.

  19. Change in Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms QOL/Sym Score at 24 Months [ Time Frame: 24 Month ]
    Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES QOL/Sym). Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Baseline score minus the Follow-up score (24 months). A positive change is associated with improved outcome.

  20. Change in Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms QOL/Sym Score at 36 Months [ Time Frame: 36 Month ]
    Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES QOL/Sym). Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Baseline score minus the Follow-up score (36 months). A positive change is associated with improved outcome.

  21. Change in Villalta Score at 6-, 12 Months Compared to Baseline [ Time Frame: Baseline to 6 and 12 months ]
    Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS. Change in Villalta scores were calculated as the Baseline score minus the Follow-up score (6 or 12 months). A negative change is associated with improved outcome.

  22. Change in Villalta Score at 24 Months Compared to Baseline [ Time Frame: 24 Month ]
    Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS. Change in Villalta scores were calculated as the Baseline score minus the Follow-up score (24 months). A negative change is associated with improved outcome.

  23. Change in Villalta Score at 36 Months Compared to Baseline [ Time Frame: 36 Month ]
    Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS. Change in Villalta scores were calculated as the Baseline score minus the Follow-up score (36 months). A negative change is associated with improved outcome.

  24. Change in EuroQol-5 Dimension (EQ-5D) Score at 6-, 12 Months Compared to Baseline [ Time Frame: Baseline to 6 and 12 Months ]
    Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health). A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Baseline score minus the Follow-up score (6 or 12 months) for both the index and VAS scores.

  25. Change in EuroQol-5 Dimension (EQ-5D) Score at 24 Months Compared to Baseline [ Time Frame: 24 Month ]
    Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health). A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Baseline score minus the Follow-up score (24 months) for both the index and VAS scores.

  26. Change in EuroQol-5 Dimension (EQ-5D) Score at 36 Months Compared to Baseline [ Time Frame: 36 Month ]
    Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health). A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Baseline score minus the Follow-up score (36 months) for both the index and VAS scores.

  27. Change in Venous Clinical Severity Score (VCSS) at 6-, and 12 Months Compared to Baseline [ Time Frame: Baseline to 6 and 12 months ]
    VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Baseline score minus the Follow-up score (6 or 12 months). A negative change is associated with improved outcome.

  28. Change in Venous Clinical Severity Score (VCSS) at 24 Months Compared to Baseline [ Time Frame: 24 Month ]
    VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Baseline score minus the Follow-up score (24 months). A negative change is associated with improved outcome.

  29. Change in Venous Clinical Severity Score (VCSS) at 36 Months Compared to Baseline [ Time Frame: 36 Month ]
    VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Baseline score minus the Follow-up score (36 months). A negative change is associated with improved outcome.

  30. Major Bleeding Complication at 30 Days, 6-, 12 Months [ Time Frame: 30 days, 6 months, and 12 months ]
    A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more is related to bleeding occurring during the index procedure through 12 months post-index procedure.

  31. Major Bleeding Complication at 24 Months [ Time Frame: 24 Month ]
    A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more is related to bleeding occurring during the index procedure through 24 months post-index procedure.

  32. Major Bleeding Complication at 36 Months [ Time Frame: 36 Month ]
    A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more is related to bleeding occurring during the index procedure through 36 months post-index procedure.

  33. Subject Re-hospitalization Through 12 Months [ Time Frame: 6 and 12 months ]
    Number of subjects that were re-hospitalized due to their target lesion within 180 days from the Index Procedure and number of subjects that were re-hospitalized due to their target lesion from 181 to 360 days from the Index Procedure.

  34. Subject Re-hospitalization Through 24 Months [ Time Frame: 24 Month ]
  35. Subject Re-hospitalization Through 36 Months [ Time Frame: 36 Month ]


Information from the National Library of Medicine

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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:

  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)

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
  Study Documents (Full-Text)

Documents provided by Medtronic Endovascular:
Study Protocol  [PDF] September 24, 2018
Statistical Analysis Plan  [PDF] February 14, 2020

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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
Results First Posted: March 8, 2021
Last Update Posted: March 8, 2021
Last Verified: February 2021
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