VBX Balloon Expandable Endoprosthesis vs Bare Metal Stent for Peripheral Arterial Disease
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: W.L.Gore & Associates
Must not be taking: Antithrombotics
Disqualifiers: Pregnancy, Renal insufficiency, Infection, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have a known intolerance to antithrombotic medications, you may not be able to participate.
Is the VBX Balloon Expandable Endoprosthesis generally safe for use in humans?
The VBX Balloon Expandable Endoprosthesis has been evaluated for safety in various studies, including its use in peripheral vessels and for aortic repairs. It has shown safety in these contexts, with studies assessing its use in complex procedures like branched endovascular aortic repair and iliac artery stenosis, indicating it is generally safe for human use.
12345What makes the VBX Balloon Expandable Endoprosthesis unique for treating Peripheral Arterial Disease?
The VBX Balloon Expandable Endoprosthesis is unique because it offers precise sizing and lower profile delivery compared to self-expanding stents, making it advantageous for treating peripheral arterial disease. Its balloon-expandable nature allows for better control and placement in the arteries, which can be crucial for effective treatment.
678910Eligibility Criteria
Adults over 18 with complex iliac occlusive disease, who can follow the study plan and have specific types of blockages in their pelvic arteries. They must not be pregnant, allergic to stent materials like nitinol or heparin, have severe kidney issues, recent lower extremity vascular procedures (except certain angiograms), previous iliac artery stents or surgeries, or require other leg artery treatments.Inclusion Criteria
I experience leg pain when walking, pain at rest, or have minor tissue loss.
I have at least one leg artery that is not majorly blocked.
I have new or recurring blockage in my pelvic arteries.
+6 more
Exclusion Criteria
Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).
I have a systemic infection.
I had a procedure for my leg veins within the last 30 days.
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis or a bare metal stent for treatment of complex iliac occlusive disease
At the procedure
Follow-up
Participants are monitored for primary patency and other outcomes, including freedom from revascularization and survival
5 years
Participant Groups
This trial is testing if the GORE VIABAHN VBX Balloon Expandable Endoprosthesis is better for keeping blood vessels open compared to traditional bare metal stents in patients with complicated blockages in the pelvic arteries.
2Treatment groups
Active Control
Group I: BMS Control GroupActive Control1 Intervention
Subjects in this group will receive treatment with a commercially available bare metal stent (BMS) that is approved for treatment of the disease
Group II: VBX Device GroupActive Control1 Intervention
Subject in this group will receive treatment with the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
Bare Metal Stent is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Bare Metal Stent for:
- Iliac occlusive disease
- Aortoiliac occlusive disease
- Peripheral arterial disease
🇪🇺 Approved in European Union as Bare Metal Stent for:
- Iliac occlusive disease
- Aortoiliac occlusive disease
- Peripheral arterial disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Southwestern Medical CenterDallas, TX
Texas Tech University Health Science CenterLubbock, TX
University of PennsylvaniaPhiladelphia, PA
Radiology and Imaging Specialists of LakelandLakeland, FL
More Trial Locations
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Who Is Running the Clinical Trial?
W.L.Gore & AssociatesLead Sponsor
References
One-year results of a balloon expandable endoprosthesis as a bridging stent for branched endovascular aortic repair. [2023]This post-market multicenter registry aimed to evaluate the safety and performance of the GORE VIABAHN VBX balloon expandable endoprosthesis (VBX stent) implanted in peripheral vessels. In this subgroup analysis, we assessed the outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair at 1 year.
Use of the Gore Viabahn VBX balloon-expandable endoprosthesis in the congenital heart disease population. [2020]The Gore Viabahn VBX balloon-expandable endoprosthesis (W. L. Gore & Associates, Flagstaff, AZ) is a flexible covered stent that is FDA-approved for the treatment of iliac artery stenosis, including lesions at the aortic bifurcation. In this case series, we report the first use of the VBX covered stent in congenital heart disease, highlighting several of its unique advantages.
First/Preliminary Experience of Gore Viabahn Balloon-Expandable Endoprosthesis as Bridging Stent in Fenestrated and Branched Endovascular Aortic Repair. [2020]The aim of this study is to evaluate the preliminary outcomes of the Gore® Viabahn® balloon-expandable endoprosthesis (VBX) as bridging stent for fenestrated/branched aortic endograft.
Initial Experience With Viabahn VBX as the Bridging Stent Graft for Branched and Fenestrated Endovascular Aneurysm Repair. [2022]To evaluate the feasibility and safety of a novel balloon-expandable, heparin-bonded endoprosthesis (Viabahn VBX, W. L. Gore and Associates) when used as a bridging stent graft (BSG) with fenestrated and branched endovascular aneurysm repair (FB-EVAR). FB-EVAR and BSGs increase repair complexity with the potential for endoleak formation, stenosis, thrombosis, and graft migration. The mechanical construction of the Viabahn VBX and its antithrombogenic properties may provide an advantage for FB-EVAR over existing BSGs. The efficacy, safety, and clinical outcomes were assessed.
Long-Term Follow-up of Subjects With Iliac Occlusive Disease Treated With the Viabahn VBX Balloon-Expandable Endoprosthesis. [2023]This physician-initiated study provides 5-year (i.e., long-term) treatment durability data from 3 top recruitment sites that participated in the prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study (ClinicalTrials.gov identifier: NCT02080871). It evaluates the long-term treatment durability of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of subjects with de novo or restenotic aortoiliac lesions.
Evaluation of the maintenance of the apical limit during instrumentation with hybrid equipment in rotary and reciprocating modes. [2017]The objective of the present study was to evaluate ex vivo the maintenance of the apical limit during instrumentation with the Root ZX (J Morita, Tokyo, Japan) and VDW Gold (VDW GbmH, Munich, Germany) hybrid devices in rotary and reciprocating modes and determine the possible function variations of different preparation levels (0.0 mm and -1.0 mm).
Assessment of Apical Extrusion during Root Canal Irrigation with the Novel GentleWave System in a Simulated Apical Environment. [2017]This study assessed apical extrusion during treatment with GentleWave (GW; Sonendo Inc, Laguna Hills, CA), a conventional open-ended 30-G needle (CN), or Endovac (EV; SybronEndo, Orange, CA) in root canals enlarged to different dimensions with and without apical constriction.
Outcomes of the Gore® Excluder® Iliac Branch Endoprosthesis Using Self Expanding or Balloon-Expandable Stent Grafts for the Internal Iliac Artery Component. [2023]Label="OBJECTIVE" NlmCategory="UNASSIGNED">The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Arizona) was developed to be used in combination with a self-expanding stent graft (SESG) for the internal iliac artery (IIA) bridging stent. Balloon-expandable stent grafts (BESGs) are an alternative for the IIA, offering advantages in sizing, device tracking, precision, and lower profile delivery. We compared the performance of SESG and BESG when used as the IIA bridging stent in patients undergoing EVAR with IBE.
Iliocaval reconstruction of chronically thrombosed cylindrical inferior vena cava filters with balloon expandable covered stent-grafts. [2021]The use of a Viabahn VBX endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) to exclude chronically thrombosed inferior vena cava (IVC) filters refractory to exclusion with self-expanding stents was evaluated. The mean duration of TrapEase IVC (Cordis, Milpitas, Calif) implantation was 7.6 years (range, 2-11 years). Symptoms included leg pain, edema, color changes, and back pain. The mean Villalta score and venous clinical severity score were 17 (range, 13-23) and 13 (range, 11-15), respectively. Indirect ultrasound evidence of stent patency was demonstrated at a mean of 8 months after intervention. The mean Villalta score and venous clinical severity score had decreased by 13 and 10, respectively, at a mean of 9.5 months after intervention. Iliocaval reconstruction with Viabahn VBX balloon expandable stent-graft exclusion of chronically thrombosed TrapEase IVC filters is safe, with favorable short-term results.
Gutter Characteristics and Stent Compression of Self-Expanding vs Balloon-Expandable Chimney Grafts in Juxtarenal Aneurysm Models. [2020]Purpose: To assess in silicone juxtarenal aneurysm models the gutter characteristics and compression of different types of chimney graft (CG) configurations. Materials and Methods: Fifty-seven combinations of Excluder C3 or Conformable Excluder stent-grafts (23, 26, and 28.5 mm) were deployed in 2 silicone juxtarenal aneurysm models with 3 types of CGs: Viabahn self-expanding (VSE; 6 and 13 mm) or Viabahn balloon-expandable (VBX; 6, 10, and 12 mm) stent-grafts and Advanta V12 balloon-expandable stent-grafts (ABX; 6 and 12 mm). Setups were divided into 4 groups on the basis of increasing CG and main graft (MG) diameters. Two independent observers assessed gutter size and type as well as CG compression on computed tomography scans using postprocessing software. Results: In the smaller diameter combinations (6-mm CG and 23-, 26-, and 28.5-mm MGs), both VSE (p=0.006 to 0.050) and ABX (p=0.045 to 0.050) showed lower gutter areas and volumes compared with VBX. In turn, the VBX showed a nonsignificant tendency to decreased compression, especially compared to ABX. Use of the Excluder C3 showed a 6-fold increase in type A1 gutters (related to type Ia endoleak) as compared to the Conformable Excluder (p=0.018). Balloon-expandable stent-grafts (both ABX and VBX) showed a 3-fold increase in type A1 gutters in comparison with self-expanding stent-grafts (p=0.008). Conclusion: The current study suggests that use of the Conformable Excluder in combination with VSE chimney grafts is superior to the other tested CG/MG combinations in terms of gutter size, gutter type, and CG compression.