Vein Thrombosis, Venous Disease, Venous Leg Ulcer, Venous Occlusion, Venous Stasis, Venous Stenosis, Venous Thromboses, Venous Ulcer
Conditions
Keywords
Vein Stent, VIAFORT, Venous Thrombosis, Venous Stenosis, Gore, Venous occlusion, VIABAHN FORTEGRA, FORTEGRA, Deep Venous Insufficiency, Deep venous, Venous Disease, DVT Treatment, Venous Stent, Venous insufficiency treatment options, Venous disease treatment options
Brief summary
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
Detailed description
A maximum of 35 clinical investigative sites in the U.S. will participate in this study. One hundred and fifty subjects are intended to be implanted with the GORE® VIABAHN® FORTEGRA Venous Stent in this study, with a limit of 30 treated subjects per site. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, and 36 months post-treatment.
Interventions
DEVICEGORE® VIABAHN® FORTEGRA Venous Stent
Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a prospective, multicenter, single-arm study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Preoperative Inclusion Criteria: * Presence of a lesion necessitating treatment with the GORE® VIABAHN® FORTEGRA Venous Stent, as previously determined by an investigator/sub-investigator. * 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 themself. Intraoperative Inclusion Criteria: * Patient can accommodate an appropriately sized GORE® VIABAHN® FORTEGRA Venous 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 beyond the proximal and distal margins of the lesion. * Patient has adequate inflow/outflow to/from the target lesion(s), per investigator/sub- investigator discretion. * Lesion can be traversed with a guidewire. Intraoperative
Exclusion criteria
* Patient is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary effectiveness as assessed by primary patency | 12 months | Rate of subjects with primary patency as confirmed by imaging and adverse events |
| Primary safety as assessed by SAEs | 30 days | Rate of subjects with freedom from device- or index procedure-related SAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of subjects with primary patency as confirmed by imaging and adverse events | 36 months | Rate 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 |
| Rate of subjects with secondary patency as confirmed by imaging and site-reported device abandonment | 36 months | Freedom from permanent loss of blood flow through the device, regardless of reintervention |
| Rate of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events | 36 months | Rate of subjects with Repeat endovascular procedures (e.g., PTA, stenting, thrombectomy/thrombolysis) to restore flow, performed within the margins of the study devices due to ≥50% restenosis of the target lesion as measured via imaging AND the failure to improve or recurrence of symptoms present at baseline, or the onset of new symptoms related to the target lesion |
| Number of subjects with stent embolization as confirmed by adverse events and imaging | 12 months | Number of subjects with stent embolization |
| Number of subjects with device- or index procedure-related death as confirmed with adverse events | 30 days | Number of subjects with device- or index procedure-related death |
| Number of subjects with clinically significant pulmonary embolism as confirmed with imaging and adverse events | 30 days | Number of subjects with clinically significant pulmonary embolism as confirmed via CTA |
| Number of subjects with device- or index procedure-related vascular injury as confirmed with adverse events | 30 days | Number of subjects with device- or index procedure-related vascular injury requiring surgical or endovascular intervention |
| Number of subjects with device- or index procedure-related major bleeding events as confirmed with adverse events | 30 days | Number of subjects with device- or index procedure-related major bleeding events |
| 5 Level EuroQol-5 Dimension (EQ-5D-5L) | 36 months | Change in 5 Level EuroQol-5 Dimension (EQ-5D-5L) Measurement through 36-month follow-up compared to baseline prior to treatment |
| Technical success | Index procedure (post-op day 0) | Number of subjects with successful delivery and deployment of the stent to the intended location |
| Lesion success | Index procedure (post-op day 0) | Number of subjects with evidence of ≤50% residual stenosis at the conclusion of the index procedure as measured by IVUS or contrast angiography |
Contacts
CONTACTChaz Wolf
CONTACTLeonard Resecker
PRINCIPAL_INVESTIGATORErin Murphy, MD
Atrium Health Sanger Heart and Vascular Institute
PRINCIPAL_INVESTIGATORParag Patel, MD
Medical College of Wisconsin
Outcome results
None listed