Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05409976
Registration number
NCT05409976
Ethics application status
Date submitted
17/05/2022
Date registered
8/06/2022
Date last updated
5/06/2024
Titles & IDs
Public title
The GORE® VIAFORT Vascular Stent IVC Study
Query!
Scientific title
Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Inferior Vena Cava Obstruction With or Without Combined Iliofemoral Obstruction
Query!
Secondary ID [1]
0
0
VNS 21-05
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Venous Thromboses
0
0
Query!
Venous Disease
0
0
Query!
Venous Leg Ulcer
0
0
Query!
Venous Stasis
0
0
Query!
Venous Ulcer
0
0
Query!
Venous Stenosis
0
0
Query!
Venous Occlusion
0
0
Query!
Vein Thrombosis
0
0
Query!
Vein Occlusion
0
0
Query!
Vein Disease
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Composite of efficacy and safety events
Query!
Assessment method [1]
0
0
Composite primary endpoint consisting of freedom from the following:
Loss of primary patency through 12-month follow-up
Stent embolization through 12-month follow-up
Device- or procedure-related death through 30 days
Clinically significant pulmonary embolism confirmed via Computed Tomography Angiography through 30 days
Device- or procedure-related vascular injury through 30 days requiring surgical or endovascular intervention
Device- or procedure-related major bleeding events through 30 days
Query!
Timepoint [1]
0
0
12 months
Query!
Secondary outcome [1]
0
0
Number of subjects with primary patency as confirmed by imaging and adverse events
Query!
Assessment method [1]
0
0
Number of subjects with freedom from both:
stent occlusion due to restenosis or thrombosis as confirmed with imaging, and
clinically driven target lesion revascularization as confirmed with imaging and adverse events
Query!
Timepoint [1]
0
0
60 months
Query!
Secondary outcome [2]
0
0
Number of subjects with secondary patency as confirmed by imaging and adverse events
Query!
Assessment method [2]
0
0
Number of subjects with freedom from permanent loss of blood flow through the device, regardless of reintervention.
Query!
Timepoint [2]
0
0
60 months
Query!
Secondary outcome [3]
0
0
Number of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events
Query!
Assessment method [3]
0
0
Number of subjects with repeat endovascular procedures (e.g., PTA, stenting, thrombectomy/thrombolysis) to restore flow, performed within the margins of the investigational devices due to =50% restenosis of the target lesion as measured via imaging AND the failure to improve or recurrence of venous origin leg pain or venous edema related to the target lesion present at baseline, or the onset of new symptoms including venous origin pain and venous edema related to the target lesion.
Query!
Timepoint [3]
0
0
60 months
Query!
Secondary outcome [4]
0
0
Number of subjects with device fracture as confirmed with imaging
Query!
Assessment method [4]
0
0
Number of subjects with device fracture as confirmed with imaging.
Query!
Timepoint [4]
0
0
60 months
Query!
Secondary outcome [5]
0
0
Number of subjects with stent embolization as confirmed with imaging
Query!
Assessment method [5]
0
0
Number of subjects with stent embolization as confirmed with imaging.
Query!
Timepoint [5]
0
0
12 months
Query!
Secondary outcome [6]
0
0
Number of subjects with device- or procedure-related death
Query!
Assessment method [6]
0
0
Number of subjects with device- or procedure-related death.
Query!
Timepoint [6]
0
0
30 days
Query!
Secondary outcome [7]
0
0
Number of subjects with clinically significant pulmonary embolism as confirmed with imaging and adverse events
Query!
Assessment method [7]
0
0
Number of subjects with clinically significant pulmonary embolism confirmed via Computed Tomography Angiography through 30 days.
Query!
Timepoint [7]
0
0
30 days
Query!
Secondary outcome [8]
0
0
Number of subjects with device- or procedure-related vascular injury as confirmed with adverse events
Query!
Assessment method [8]
0
0
Number of subjects with device- or procedure-related vascular injury through 30 days requiring surgical or endovascular intervention.
Query!
Timepoint [8]
0
0
30 days
Query!
Secondary outcome [9]
0
0
Number of subjects with device- or procedure-related major bleeding events as confirmed with adverse events
Query!
Assessment method [9]
0
0
Number of subjects with device- or procedure-related major bleeding events through 30 days.
Query!
Timepoint [9]
0
0
30 days
Query!
Secondary outcome [10]
0
0
Revised Venous Clinical Severity Scale (rVCSS)
Query!
Assessment method [10]
0
0
Change in Revised Venous Clinical Severity Scale (rVCSS) Measurement through 60-month follow-up compared to baseline prior to treatment.
Note: The rVCSS scale ranges from 0 to 30, with higher scores reflecting worse symptoms.
Query!
Timepoint [10]
0
0
60 months
Query!
Secondary outcome [11]
0
0
Revised Venous Clinical Severity Scale (rVCSS) Pain
Query!
Assessment method [11]
0
0
Change in Revised Venous Clinical Severity Scale (rVCSS) Pain Measurement through 60-month follow-up compared to baseline prior to treatment.
Note: The rVCSS Pain scale ranges from 0 to 3, with higher scores reflecting worse pain.
Query!
Timepoint [11]
0
0
60 months
Query!
Secondary outcome [12]
0
0
Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) VEINES-QOL/Sym
Query!
Assessment method [12]
0
0
Change in Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) Measurement through 60-month follow-up compared to baseline prior to treatment.
Query!
Timepoint [12]
0
0
60 months
Query!
Secondary outcome [13]
0
0
Villalta
Query!
Assessment method [13]
0
0
Change in Villalta Measurement through 60-month follow-up compared to baseline prior to treatment.
Query!
Timepoint [13]
0
0
60 months
Query!
Secondary outcome [14]
0
0
5 Level EuroQol-5 Dimension (EQ-5D-5L)
Query!
Assessment method [14]
0
0
Change in 5 Level EuroQol-5 Dimension (EQ-5D-5L) Measurement through 60-month follow-up compared to baseline prior to treatment.
Query!
Timepoint [14]
0
0
60 months
Query!
Secondary outcome [15]
0
0
Technical success
Query!
Assessment method [15]
0
0
Number of subjects with successful delivery and deployment of the stent to the intended location, and removal of delivery system.
Query!
Timepoint [15]
0
0
Index procedure (post-op day 0)
Query!
Secondary outcome [16]
0
0
Lesion success
Query!
Assessment method [16]
0
0
Number of subjects with evidence of =50% residual stenosis at the conclusion of the index procedure as measured by IVUS or venogram.
Query!
Timepoint [16]
0
0
Index procedure (post-op day 0)
Query!
Secondary outcome [17]
0
0
Procedural success
Query!
Assessment method [17]
0
0
Number of subjects with lesion success and the absence of major adverse events (i.e., stent embolization, device- or procedure-related death, clinically significant pulmonary embolism, device- or procedure-related vascular injury requiring surgical or endovascular intervention, and device- or procedure-related major bleeding) prior to discharge.
Query!
Timepoint [17]
0
0
Index procedure through hospital discharge (discharge estimated as up to 30 days post-treatment)
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/10/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/01/2029
Query!
Actual
Query!
Sample size
Target
111
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
SA,WA
Query!
Recruitment hospital [1]
0
0
Flinders Medical Centre - Adelaide
Query!
Recruitment hospital [2]
0
0
Sir Charles Gairdner Hospital - Nedlands
Query!
Recruitment hospital [3]
0
0
Royal Perth Hospital - Perth
Query!
Recruitment postcode(s) [1]
0
0
5042 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [3]
0
0
6000 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Michigan
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Virginia
Query!
Country [10]
0
0
Germany
Query!
State/province [10]
0
0
Aachen
Query!
Country [11]
0
0
Germany
Query!
State/province [11]
0
0
Arnsberg
Query!
Country [12]
0
0
Ireland
Query!
State/province [12]
0
0
Connaught
Query!
Country [13]
0
0
Italy
Query!
State/province [13]
0
0
Milan
Query!
Country [14]
0
0
Italy
Query!
State/province [14]
0
0
Modena
Query!
Country [15]
0
0
New Zealand
Query!
State/province [15]
0
0
Auckland
Query!
Country [16]
0
0
United Kingdom
Query!
State/province [16]
0
0
Cambridge
Query!
Country [17]
0
0
United Kingdom
Query!
State/province [17]
0
0
London
Query!
Country [18]
0
0
United Kingdom
Query!
State/province [18]
0
0
Oxford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
W.L.Gore & Associates
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the
performance, safety, and efficacy of the GORE® VIAFORT Vascular Stent for treatment of
symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction
in adult patients.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05409976
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Kush Desai, MD
Query!
Address
0
0
Northwestern University
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Carl Conway
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
6175952277
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05409976
Download to PDF