Iliofemoral Venous ObstructionNCT03038438
ABRE Clinical Study of the Abre Venous Self-expanding Stent System
A study testing Abre venous self-expanding stent system in people with Iliofemoral Venous Obstruction, run by Medtronic Endovascular at 24 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Iliofemoral Venous Obstruction
- What is being tested?
- Abre venous self-expanding stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 13 Dec 2017to 28 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
- ≥50% in diameter reduction on venography or IVUS, or
- ≥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 (renal compromise defined as GFR>30). Patients with underlying obstructive lesions can then be included in the study within the same procedure;
- Target vessel can accommodate a 9 French Sheath, from insertion site to target segment;
- Exchangeable guidewire must cross target lesion(s) with successful predilation.
Who cannot join
- 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;
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- 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)
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
United States16 sites
Albany Medical Center
Albany, New York, 12208
University of Michigan Health System
Ann Arbor, Michigan, 48109
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
Lake Washington Vascular, PLLC
Bellevue, Washington, 98004
Carolinas Medical Center
Charlotte, North Carolina, 28203
OhioHealth Research Institute
Columbus, Ohio, 43214
The Vascular Experts
Darien, Connecticut, 06820
Cardiac Center of Texas
McKinney, Texas, 75069
NYU Langone Medical Center
New York, New York, 10016
The Mount Sinai Health System
New York, New York, 10029
Sentara Vascular Specialists
Norfolk, Virginia, 23507
St. Joseph Hospital
Orange, California, 92868
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
Mayo Clinic
Rochester, Minnesota, 55902
Stony Brook Medicine
Stony Brook, New York, 11794
Holy Name Medical Center
Teaneck, New Jersey, 07666
France2 sites
Assistance Publique - Hôpitaux de Marseille - Hôpital Nord
Marseille, 13915
Hôpital Européen Georges Pompidou
Paris, 75015
Germany2 sites
Universitätsklinikum Aachen
Aachen, D-52074
Klinikum Arnsberg, Karolinen Hospital
Arnsberg, D-59759
United Kingdom2 sites
University College London Hospitals NHS Foundation Trust - University College London Hospitals
London, NW1 2PG
Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital
London, SE1 7EH
Ireland1 site
Galway University Hospitals - University Hospital Galway
Galway, H91 YR71
About this study
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
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
- Being tested
- Abre venous self-expanding stent system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abre venous self-expanding stent systemDevice
venous stent
| Study group | Role | What they receive |
|---|---|---|
| Abre | Experimental | Abre Venous Self-expanding Stent System Receives: Device: Abre venous self-expanding stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency
Freedom from occlusion of the stented segment; Freedom from restenosis >=50%; and Freedom from clinically-driven target lesion revascularization
Measured: 12 Months
Composite Major Adverse Events
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
Measured: 30 Days
Secondary outcomes (16)
Device Success
Successful delivery and deployment of the stent and removal of the delivery system during the index procedure. Stent based outcome measure.
Measured: Index Procedure
Lesion Success Obtained at Index Procedure
Venographic evidence of <50% residual stenosis of the stented segment of the target lesion after post-dilation.
Measured: Index Procedure
Index Procedure Success
Lesion success without procedure-related MAEs prior to hospital discharge
Measured: 30 days
Primary Patency
Primary Patency: Defined as meeting all of the following criteria:
- Freedom from occlusion of the stented segment of the target lesion;
- Freedom from restenosis ≥50% of the stented segment of the target lesion;
- Freedom from clinically driven target lesion revascularization.
Measured: 24 Months, 36 Months
Primary Assisted Patency
Uninterrupted patency of the stented segment of the target lesion with a secondary intervention, also known as an adjunctive treatment (e.g. balloon venoplasty, subsequent stenting, etc.)
Measured: 12 Months, 24 Months, 36 Months
Secondary Patency
Secondary patency is defined as patency of the stented segment of the target lesion after subsequent intervention for an occlusion.
Measured: 12 Months, 24 Months, 36 Months
Stent Fracture
X-ray for the 30-day visit was only required on the first 30 subjects. Stent Fracture within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1080, respectively.
Measured: 30 Days, 12 Months, 24 Months, 36 Months
Target Lesion Revascularization
Percentage of subjects with target lesion revascularization through 30 days, 180 days, 360 days, 720, and 1080 days.
Measured: 30 days, 6 months, 12 months, 24 months, 36 months
Delayed Stent Migration
Delayed Stent Migration within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1140, respectively.
Measured: 12 Months, 24 Months, 36 Months
Major Adverse Events
Safety endpoints (MAE, TLR, and Major Bleeding) included subjects with an event or without an event but follow-up days have reached 150 days for 6-month, 330 days for 12-month, 690 days for 24-month, and 1050 days for 36-month visit.
Measured: 6 Months, 12 Months, 24 Months, 36 Months
Major Bleeding Related to Index Procedure
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 post-index procedure is related to bleeding occurring during the index procedure.
Measured: 30 Days, 6 Months, 12 Months, 24 Months, 36 Months
Re-Hospitalization
Number of subjects that were re-hospitalized due to their target lesion from the Index Procedure.
Measured: 0-180, 181-360, 361-720, 721-1080 and 0-1080 days
Villalta Score
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 Follow-up score minus the Baseline score (6, 12, 24, or 36 months).
A negative change is associated with improved outcome.
Measured: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Venous Clinical Severity Score (VCSS)
VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Follow-up score minus the Baseline score.
A negative change is associated with improved outcome.
Measured: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
EuroQol-5 Dimension (EQ-5D) Score
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 Follow-up score minus the Baseline score (6, 12, 24, and 24 months) for both the index and VAS scores.
Measured: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score
Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (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 Follow-up score minus the Baseline score (6, 12, 24, or 36 months).
A positive change is associated with improved outcome.
Measured: Change from Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start13 Dec 2017
- Primary completion14 Jan 2020
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iliofemoral Venous ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin Murphy, MD, Principal investigator, Carolinas Health Care SystemStephen Black, MD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038438
- Sponsor's protocol ID
- APV-ABRE
- Status last verified
- Oct 2022
- First submitted
- 28 Jan 2017
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35105153
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03038438
- Acronym / sponsor ID
- APV-ABRE
- Conditions
- Iliofemoral Venous Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Posted 8 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abre | Experimental | Device: Abre venous self-expanding stent systemAbre Venous Self-expanding Stent System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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);
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abre venous self-expanding stent systemvenous stent | Device | Abre |
Primary outcome
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
16 secondary outcomes
Device Success
Time frame: Index Procedure
Lesion Success Obtained at Index Procedure
Time frame: Index Procedure
Index Procedure Success
Time frame: 30 days
Primary Patency
Time frame: 24 Months, 36 Months
Primary Assisted Patency
Time frame: 12 Months, 24 Months, 36 Months
Secondary Patency
Time frame: 12 Months, 24 Months, 36 Months
Stent Fracture
Time frame: 30 Days, 12 Months, 24 Months, 36 Months
Target Lesion Revascularization
Time frame: 30 days, 6 months, 12 months, 24 months, 36 months
Delayed Stent Migration
Time frame: 12 Months, 24 Months, 36 Months
Major Adverse Events
Time frame: 6 Months, 12 Months, 24 Months, 36 Months
Major Bleeding Related to Index Procedure
Time frame: 30 Days, 6 Months, 12 Months, 24 Months, 36 Months
Re-Hospitalization
Time frame: 0-180, 181-360, 361-720, 721-1080 and 0-1080 days
Villalta Score
Time frame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Venous Clinical Severity Score (VCSS)
Time frame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
EuroQol-5 Dimension (EQ-5D) Score
Time frame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score
Time frame: Change from Baseline to 6 Months, 12 Months, 24 Months, 36 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35105153Murphy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Murphy, MD principal investigator
Carolinas Health Care System
Stephen Black, MD principal investigator
Guy's and St Thomas' NHS Foundation Trust
24 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abre venous self-expanding stent system in people with Iliofemoral Venous Obstruction, run by Medtronic Endovascular at 24 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, France, Germany, United Kingdom, Ireland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03038438, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.