VBX Balloon Expandable Endoprosthesis vs Bare Metal Stent for Peripheral Arterial Disease

Recruiting at 7 trial locations

Overseen By Makensley Lordeus

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: W.L.Gore & Associates

Must not be taking: Antithrombotics

Disqualifiers: Pregnancy, Renal insufficiency, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: At the procedure

244 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best treatment for complex iliac occlusive disease, a condition where narrowed or blocked arteries in the pelvis cause leg pain or difficulty walking. Researchers compare two treatments: a bare metal stent, a small tube that keeps arteries open, and the VBX Balloon Expandable Endoprosthesis, a stent designed for better artery patency. The trial aims to determine if the VBX device outperforms the standard stent. Individuals experiencing leg pain, rest pain, or minor tissue loss due to blocked pelvic arteries might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to important research that could enhance treatment options for future patients.

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.

What prior data suggests that the VBX Device is safe for treating complex iliac occlusive disease?

Research has shown that the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is generally safe and well-tolerated. Studies have found it effective for treating peripheral artery disease, even in challenging areas of the body. Reports from previous studies indicate successful use without major safety concerns.

Bare metal stents (BMS) have FDA approval for treating similar conditions, suggesting their safety. While specific side effects can vary, both treatments have a history of safety in managing artery diseases. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis because it offers a potentially more effective approach for treating Peripheral Arterial Disease compared to traditional bare metal stents. Unlike standard bare metal stents, the VBX device features a balloon-expandable design that allows for precise placement and expansion, adapting to different vessel sizes and conditions. This flexibility can lead to improved outcomes in vessel patency and reduced risk of restenosis. Additionally, the unique design aims to offer better support and durability, which could enhance long-term treatment success and improve patient quality of life.

What evidence suggests that this trial's treatments could be effective for peripheral arterial disease?

Research has shown that the GORE VIABAHN VBX Balloon Expandable Endoprosthesis, which participants in this trial may receive, effectively treats blockages in the iliac artery. One study found that this device was safe and effective over five years. Designed to handle difficult artery conditions, it is easy to use in complex situations. Early results suggest that the VBX Endoprosthesis might outperform traditional bare metal stents, used in another arm of this trial, especially in challenging cases. This makes it a promising choice for people with difficult artery blockages. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).

I have a systemic infection.

You have had a stent placed in the iliac arteries before.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Bare Metal Stent
• GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Trial Overview 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.

How Is the Trial Designed?

Group I: BMS Control Group Active Control 1 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 Group Active Control 1 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

Who Is Running the Clinical Trial?

W.L.Gore & Associates

Lead Sponsor

Trials

103

Recruited

32,900+

Bret Snyder

W.L.Gore & Associates

Chief Executive Officer since 2020

MBA from Stanford University

Dr. John Doe

W.L.Gore & Associates

Chief Medical Officer since 2023

MD from Harvard Medical School

Published Research Related to This Trial

In a study involving 72 human premolars, both the Root ZX and VDW Gold devices were found to effectively maintain the apical limit during root canal instrumentation, especially when instruments were used until the apical foramen (AF).

The precision of maintaining the apical limit decreased significantly when instruments were set to -1.0 mm from the AF, indicating that using the instruments to the AF is crucial for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the maintenance of the apical limit during instrumentation with hybrid equipment in rotary and reciprocating modes. Vasconcelos, BC., Frota, LM., Souza, Tde A., et al.[2017]

The GentleWave (GW) and Endovac (EV) systems showed no apical extrusion of irrigants during root canal treatment, indicating a safer approach compared to the conventional open-ended 30-G needle (CN), which had a 33% extrusion rate.

The amount of extruded irrigant with the CN varied significantly based on canal type and instrumentation method, with higher extrusion observed in distal canals and with overinstrumentation, suggesting that the choice of technique can impact safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Apical Extrusion during Root Canal Irrigation with the Novel GentleWave System in a Simulated Apical Environment. Charara, K., Friedman, S., Sherman, A., et al.[2017]

In a study of 41 patients undergoing endovascular aneurysm repair (EVAR) with the GORE® EXCLUDER® Iliac Branch Endoprosthesis, both self-expanding stent grafts (SESG) and balloon-expandable stent grafts (BESG) showed similar mid-term outcomes regarding internal iliac artery (IIA) patency, with no significant differences in complications.

BESGs were used in smaller IIA target arteries and offered advantages in device sizing and deployment, suggesting they can be effectively utilized without compromising the performance of the IBE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of the Gore® Excluder® Iliac Branch Endoprosthesis Using Self Expanding or Balloon-Expandable Stent Grafts for the Internal Iliac Artery Component. Cortolillo, NS., Guerra, A., Murphy, E., et al.[2023]

The Viabahn VBX endoprosthesis is a safe and effective method for excluding chronically thrombosed inferior vena cava (IVC) filters, showing favorable short-term results after intervention.

Patients experienced significant improvements in symptoms, with a decrease in Villalta and venous clinical severity scores by 13 and 10 points, respectively, at an average of 9.5 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iliocaval reconstruction of chronically thrombosed cylindrical inferior vena cava filters with balloon expandable covered stent-grafts. Elboraey, M., Toskich, BB., Lewis, AR., et al.[2021]

The GORE VIABAHN VBX Balloon Expandable Endoprosthesis demonstrated excellent long-term durability in treating aortoiliac lesions, with 5-year primary patency rates of 89.5% and freedom from target lesion revascularization at 89.1%.

The study involved 59 subjects with a median follow-up of 6.6 years, showing significant improvements in quality of life and ankle-brachial index, indicating sustained clinical benefits for patients with iliac occlusive disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Follow-up of Subjects With Iliac Occlusive Disease Treated With the Viabahn VBX Balloon-Expandable Endoprosthesis. Holden, A., Takele, E., Hill, A., et al.[2023]

In a study of 73 patients with thoracoabdominal aneurysms, the GORE VIABAHN VBX stent showed excellent safety and performance, achieving a primary patency rate of 95.8% and a secondary patency rate of 97.9% at one year.

The VBX stent was found to be a reliable bridging stent for branched endovascular aortic repair, with a high success rate of 98.6% for technical success and freedom from serious adverse events within 30 days, although patency rates were slightly lower in renal arteries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year results of a balloon expandable endoprosthesis as a bridging stent for branched endovascular aortic repair. Usai, MV., Gargiulo, M., Haulon, S., et al.[2023]

The Gore® Viabahn® balloon-expandable endoprosthesis (VBX) was successfully used as a bridging stent in 15 patients undergoing complex aortic repairs, achieving technical success in all cases without any major complications during the initial follow-up period.

While there was one instance of a type III endoleak that was successfully managed, the overall safety profile was strong, with no occlusions or reinterventions required within 30 days or at the 6-month follow-up, indicating promising efficacy for this device in aortic repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First/Preliminary Experience of Gore Viabahn Balloon-Expandable Endoprosthesis as Bridging Stent in Fenestrated and Branched Endovascular Aortic Repair. Gallitto, E., Faggioli, G., Pini, R., et al.[2020]

In a study involving 57 combinations of stent-grafts in silicone juxtarenal aneurysm models, the Conformable Excluder combined with Viabahn self-expanding chimney grafts showed the best results in terms of gutter size and compression, indicating a potentially safer option for preventing complications like endoleaks.

Balloon-expandable stent-grafts (both ABX and VBX) were associated with a higher incidence of type A1 gutters, which are linked to type Ia endoleaks, compared to self-expanding stent-grafts, suggesting that the choice of graft type can significantly impact the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gutter Characteristics and Stent Compression of Self-Expanding vs Balloon-Expandable Chimney Grafts in Juxtarenal Aneurysm Models. Meekel, JP., van Schaik, TG., Lely, RJ., et al.[2020]

The Gore Viabahn VBX balloon-expandable endoprosthesis is FDA-approved for treating iliac artery stenosis, including complex lesions at the aortic bifurcation.

This case series presents the first application of the VBX covered stent in patients with congenital heart disease, showcasing its flexibility and potential advantages in this unique patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Gore Viabahn VBX balloon-expandable endoprosthesis in the congenital heart disease population. Cole, JM., Salavitabar, A., Armstrong, AK., et al.[2020]

The Viabahn VBX stent graft was successfully deployed in 98% of cases during a pilot study involving 13 patients undergoing fenestrated and branched endovascular aneurysm repair (FB-EVAR), demonstrating its feasibility and safety as a bridging stent graft.

At a median follow-up of 223 days, the Viabahn VBX showed a 100% patency rate with no early stent thrombosis, although 46% of patients experienced endoleaks, indicating the need for further long-term efficacy studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Experience With Viabahn VBX as the Bridging Stent Graft for Branched and Fenestrated Endovascular Aneurysm Repair. Mafeld, S., Annamalai, G., Lindsay, TF., et al.[2022]

Citations

1. goremedical.com goremedical.com/products/vbx/clinical-data

Clinical Data | VIABAHN® VBX Your resource for current publications and clinical data demonstrating the utility of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in practice.

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/P160021B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40497702/

Safety and efficiency of the Gore Viabahn VBX as a bail-out ... Conclusions: The VBX represents a safe and easy-to-use stent graft for managing complications, even in challenging anatomy regions. Keywords: ...

4. jvascsurg.org jvascsurg.org/article/S0741-5214(23)01741-X/fulltext

One-year results of a balloon expandable endoprosthesis ... We assessed the outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair at 1 year.

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/1358863X241233528

Five-year outcomes of the GORE VIABAHN ... The 5-year safety and efficacy outcomes of the endoprosthesis were clinically acceptable for treating complex FP lesions in a real-world cohort of Japanese ...

6. goremedical.com goremedical.com/products/vbx

VIABAHN® VBX Balloon Expandable Endoprosthesis Find the GORE® VIABAHN® VBX covered stent graft, designed for proven success and durability in treating AIOD and other forms of peripheral artery disease.