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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05409976




Registration number
NCT05409976
Ethics application status
Date submitted
17/05/2022
Date registered
8/06/2022

Titles & IDs
Public title
The GORE® VIAFORT Vascular Stent IVC Study
Scientific title
Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Inferior Vena Cava Obstruction With or Without Combined Iliofemoral Obstruction
Secondary ID [1] 0 0
VNS 21-05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboses 0 0
Venous Disease 0 0
Venous Leg Ulcer 0 0
Venous Stasis 0 0
Venous Ulcer 0 0
Venous Stenosis 0 0
Venous Occlusion 0 0
Vein Thrombosis 0 0
Vein Occlusion 0 0
Vein Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - GORE® VIAFORT Vascular Stent

Experimental: GORE® VIAFORT Vascular Stent - GORE® VIAFORT Vascular Stent


Treatment: Devices: GORE® VIAFORT Vascular Stent
Treatment of symptomatic IVC obstruction with or without combined iliofemoral obstruction with the GORE® VIAFORT Vascular Stent.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of efficacy and safety events
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Number of subjects with primary patency as confirmed by imaging and adverse events
Timepoint [1] 0 0
60 months
Secondary outcome [2] 0 0
Number of subjects with secondary patency as confirmed by imaging and adverse events
Timepoint [2] 0 0
60 months
Secondary outcome [3] 0 0
Number of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events
Timepoint [3] 0 0
60 months
Secondary outcome [4] 0 0
Number of subjects with device fracture as confirmed with imaging
Timepoint [4] 0 0
60 months
Secondary outcome [5] 0 0
Number of subjects with stent embolization as confirmed with imaging
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Number of subjects with device- or procedure-related death
Timepoint [6] 0 0
30 days
Secondary outcome [7] 0 0
Number of subjects with clinically significant pulmonary embolism as confirmed with imaging and adverse events
Timepoint [7] 0 0
30 days
Secondary outcome [8] 0 0
Number of subjects with device- or procedure-related vascular injury as confirmed with adverse events
Timepoint [8] 0 0
30 days
Secondary outcome [9] 0 0
Number of subjects with device- or procedure-related major bleeding events as confirmed with adverse events
Timepoint [9] 0 0
30 days
Secondary outcome [10] 0 0
Revised Venous Clinical Severity Scale (rVCSS)
Timepoint [10] 0 0
60 months
Secondary outcome [11] 0 0
Revised Venous Clinical Severity Scale (rVCSS) Pain
Timepoint [11] 0 0
60 months
Secondary outcome [12] 0 0
Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) VEINES-QOL/Sym
Timepoint [12] 0 0
60 months
Secondary outcome [13] 0 0
Villalta
Timepoint [13] 0 0
60 months
Secondary outcome [14] 0 0
5 Level EuroQol-5 Dimension (EQ-5D-5L)
Timepoint [14] 0 0
60 months
Secondary outcome [15] 0 0
Technical success
Timepoint [15] 0 0
Index procedure (post-op day 0)
Secondary outcome [16] 0 0
Lesion success
Timepoint [16] 0 0
Index procedure (post-op day 0)
Secondary outcome [17] 0 0
Procedural success
Timepoint [17] 0 0
Index procedure through hospital discharge (discharge estimated as up to 30 days post-treatment)

Eligibility
Key inclusion criteria
Preoperative

* Patient is at least 18 years of age.
* Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.
* Patient is able to provide informed consent.
* One of the following: Clinical severity class of CEAP 'C' classification =3 or rVCSS pain score =2.
* Intention to treat the target areas with only the GORE® VIAFORT Vascular Stent.
* Estimated life expectancy =1 year.
* Patient is ambulatory (use of assistive walking device such as a cane or walker is acceptable).
* Patient has adequate inflow to the target lesion(s), per investigator/sub-investigator discretion, involving at least a patent femoral or deep femoral vein.

Preoperative
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient is a pregnant or breastfeeding woman, a woman planning to become pregnant through the 12-month visit, or a woman who is unwilling to practice an acceptable method of preventing pregnancy through the 12-month visit.
* Patient has clinically significant (e.g., symptoms of chest pain, hemoptysis, dyspnea, hypoxia, etc.) pulmonary embolism (confirmed via Computed Tomography Angiography) at the time of enrollment.
* Patient has a known uncorrectable bleeding diathesis or active coagulopathy meeting the following definitions: uncorrected INR>2 (not as a result of warfarin or DOAC therapy), OR platelet count <50,000 or >1,000,000 cells/mm3, OR white blood cell count <3,000 or >12,500 cells/mm3.
* Patient has impaired renal function (eGFR <30 mL/min/1.73m2) or is currently on dialysis.
* Patient has uncorrected hemoglobin of <9 g/dL.
* Patient has known history of antiphospholipid syndrome (APS) or patients with hypercoagulable states that are unwilling to take anticoagulant medications on a long-term basis.
* Patient has known homozygous inherited coagulation defect or Protein C/S deficiency.
* Patient has a planned surgical intervention (other than pre-stenting procedures such as thrombolysis or thrombectomy) within 30 days prior to or within 30 days after the planned study procedure.
* Patient is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment, in the opinion of the investigator/sub-investigator. Observational studies are permitted.
* Patient has had a previous major (i.e., above the ankle) amputation of the target lower limb.
* Patient has known sensitivity to device materials or contraindication to antiplatelets, thrombolytics, anticoagulants (including patients with known prior instances of Heparin Induced Thrombocytopenia type 2 (HIT-2)), or iodinated contrast.
* Patient has had prior stenting or grafts in the target vessels.
* Patient has a known or suspected active systemic infection at the time of the index procedure. Patients with a chronic infection (e.g., HIV, hepatitis C) that is well controlled under their current treatment regimen may be eligible.
* Patient has known history of intravenous drug abuse within one year of treatment.
* Patient has significant peripheral arterial disease (chronic Rutherford Type 2 or greater, acute Rutherford Type IIa or greater).
* Patient has a BMI >40.
* Patient is actively undergoing or plans to begin cancer treatment.

Intraoperative Inclusion Criteria:

* Presence of non-malignant obstruction of the inferior vena cava defined as occlusion or at least 50% reduction in target vessel lumen as measured by procedural IVUS and venogram, with or without non-malignant obstruction of the common femoral vein, external iliac vein, and/or common iliac vein.
* Patient can accommodate an appropriately sized GORE® VIAFORT Vascular Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.
* Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.
* Patient has adequate landing zones free from significant disease requiring treatment within the native vessels beyond the proximal and distal margins of the lesion.
* Patient has adequate inflow to the target lesion(s), per investigator/sub-investigator discretion, involving at least a patent femoral or deep femoral vein.
* Lesion can be traversed with a guidewire.
* Disease involves the inferior vena cava and may include iliofemoral segments with intent to stent all affected iliofemoral and caval segments.
* Patient does not have significant (i.e., >20% residual thrombosis) acute thrombus within the target stent area at the time of investigational device placement. Patients with acute thrombus within the target stent area must have thrombus successfully treated prior to investigational device placement. Successful thrombus treatment is defined as reestablishment of antegrade flow with =20% residual thrombosis as confirmed by IVUS and venogram, AND freedom from bleeding, vascular injury, or hemodynamically significant pulmonary embolism. After successful thrombus treatment, investigational device placement can occur within the same procedure.
* Patient does not have an inferior vena cava filter present within the target stent area at the time of investigational device placement. Patients with an inferior vena cava filter present within the target stent area must have the filter successfully removed prior to investigational device placement. Successful removal is defined as removal of the main body of the filter and intra-luminal fragments such that there is minimal risk to luminal integrity per investigator/sub-investigator discretion AND freedom from bleeding, vascular injury, or hemodynamically significant pulmonary embolism. After successful filter removal, investigational device placement can occur within the same procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2029
Actual
Sample size
Target
111
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Germany
State/province [10] 0 0
Aachen
Country [11] 0 0
Germany
State/province [11] 0 0
Arnsberg
Country [12] 0 0
Ireland
State/province [12] 0 0
Connaught
Country [13] 0 0
Italy
State/province [13] 0 0
Milan
Country [14] 0 0
Italy
State/province [14] 0 0
Modena
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Cambridge
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
W.L.Gore & Associates
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kush Desai, MD
Address 0 0
Northwestern University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carl Conway
Address 0 0
Country 0 0
Phone 0 0
6175952277
Fax 0 0
Email 0 0
cconway@wlgore.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05409976