SelfWrap for Chronic Kidney Disease

(SAVE-FistulaS Trial)

Recruiting at 23 trial locations

Overseen By Shouwen Wang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VenoStent

Disqualifiers: Congestive heart failure, Infection, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment SelfWrap for Chronic Kidney Disease?

Research on similar treatments, like bioresorbable perivascular wraps loaded with mesenchymal stem cells, shows they can help improve the function of arteriovenous fistulas (AVFs) by reducing issues like neointimal hyperplasia (a type of tissue growth that can block blood flow). This suggests that SelfWrap might also be effective in enhancing AVF maturation and function. ^{1 2 3 4 5}

Is the SelfWrap treatment generally safe for humans?

The wraps used in studies for arteriovenous fistulas (AVFs) in animal models have shown some safety concerns, such as potential inflammatory reactions and artery narrowing, which could lead to stroke. However, these studies were not conducted in humans, so the safety in humans is not fully known. ^{1 2 6 7 8}

How is the SelfWrap treatment for chronic kidney disease different from other treatments?

The SelfWrap treatment is unique because it uses a bioabsorbable perivascular wrap that can be loaded with mesenchymal stem cells (MSCs) to enhance arteriovenous fistula (AVF) maturation by reducing neointimal hyperplasia (NIH), a common cause of AVF failure. This approach offers a novel way to support AVF maturation and potentially reduce inflammation, which is different from standard care that does not involve such bioresorbable materials or cell therapies. ^{1 2 5 8 9}

Research Team

Timothy Boire, PhD

Principal Investigator

VenoStent, Inc.

Eligibility Criteria

This trial is for adults over 18 with chronic kidney disease who need a new arteriovenous fistula (AVF) for hemodialysis. Participants must be able to follow the study plan and attend check-ups for 3 years.

Inclusion Criteria

I am referred for a new arteriovenous fistula creation.

I can follow the study rules and visit the team for 3 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo AVF creation surgery with or without the SelfWrap Bioabsorbable Perivascular Wrap

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after AVF creation surgery

36 months

Treatment Details

Interventions

• SelfWrap
• Untreated AVF Control

Trial Overview The study compares the safety and effectiveness of a new bioabsorbable wrap called SelfWrap applied around an AVF, versus standard care without this wrap in patients undergoing AVF creation.

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery

Group II: Control Arm Placebo Group 1 Intervention

AVF creation surgery without any intervention (untreated AVF control, or standard of care)

SelfWrap is already approved in United States for the following indications:

Approved in United States as SelfWrap for:

• Improving the usability and durability of arteriovenous fistulas (AVFs) created for hemodialysis treatment in patients with chronic kidney disease (CKD)

Who Is Running the Clinical Trial?

VenoStent

Lead Sponsor

Trials

2

Recruited

220+

Findings from Research

Infusing gold nanoparticles (AuNPs) into a mesenchymal stem cell-seeded polymeric wrap significantly improves its radiopacity, allowing for better monitoring of the wrap's placement and integrity using micro-CT imaging over time.

The addition of AuNPs does not compromise the wrap's effectiveness in reducing neointimal hyperplasia and improving arteriovenous fistula maturation, as both AuNP-infused and non-infused wraps showed similar benefits in reducing vascular stenosis and neointima-to-lumen ratios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gold Nanoparticles for Monitoring of Mesenchymal Stem Cell-Loaded Bioresorbable Polymeric Wraps for Arteriovenous Fistulas. Barcena, AJR., Perez, JVD., Damasco, JA., et al.[2023]

The study demonstrated that absorbable polycaprolactone (PCL) perivascular wraps loaded with rosuvastatin (ROSU) significantly reduced neointimal hyperplasia (NIH), which is a common cause of arteriovenous fistula (AVF) non-maturation and failure, in a chronic kidney disease rat model.

Gold nanoparticles (AuNPs) incorporated into the wraps enhanced their visibility through imaging techniques, allowing for better monitoring of the device while also supporting AVF maturation and patency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rosuvastatin-Eluting Gold Nanoparticle-Loaded Perivascular Implantable Wrap for Enhanced Arteriovenous Fistula Maturation in a Murine Model. Klusman, C., Martin, B., Perez, JVD., et al.[2023]

The WRAPSODY™ Cell-Impermeable Endoprosthesis is being evaluated in a large-scale study involving 500 patients to assess its safety and efficacy in maintaining vascular access for hemodialysis, particularly in cases of stenosis or occlusion.

The primary outcome measures focus on the device's ability to achieve target lesion primary patency at 6 months and monitor any procedure-related complications within 30 days, with results expected to inform its real-world application in hemodialysis access management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, Multicenter, Observational Study to Evaluate a Cell-Impermeable Endoprosthesis for Treatment of Stenosis or Occlusion within the Dialysis Outflow Circuit of an Arteriovenous (AV) Fistula or AV Graft (The WRAP Registry). Rajan, DK., Kitrou, PM.[2023]

Arteriovenous grafts (AVG) are emerging as a promising alternative to arteriovenous fistulae (AVF) for vascular access in dialysis patients, especially for those with inadequate fistula maturation due to factors like aging and venous injury.

Recent advancements in AVG technology, including biohybrid and tissue-engineered grafts, show potential for improved biocompatibility and reduced complications compared to traditional materials, suggesting a more personalized approach to vascular access could enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How arteriovenous grafts could help to optimize vascular access management. Besarab, A., Kumbar, L.[2019]

Bioresorbable perivascular scaffolds made from polycaprolactone (PCL) significantly enhance the maturation of arteriovenous fistulas (AVFs) in chronic kidney disease (CKD) rats by improving key parameters like luminal diameter and flow rate, compared to controls without scaffolds.

When mesenchymal stem cells (MSCs) are added to the PCL scaffolds, there is an even greater improvement in AVF maturation and a significant reduction in inflammation, suggesting that MSCs not only support vascular growth but also help minimize neointimal hyperplasia (NIH).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioresorbable Mesenchymal Stem Cell-Loaded Electrospun Polymeric Scaffold Inhibits Neointimal Hyperplasia Following Arteriovenous Fistula Formation in a Rat Model of Chronic Kidney Disease. Barcena, AJR., Perez, JVD., Bernardino, MR., et al.[2023]

In a study of 15 patients who underwent microsurgical wrapping of intracranial aneurysms (IAs), there was a 20% incidence of delayed cerebrovascular complications, including ischemic stroke and granuloma formation, highlighting potential risks associated with this treatment.

The literature review of 197 cases showed a 12% rebleeding rate in patients with ruptured aneurysms after wrapping, indicating that while the risk is lower than untreated ruptured aneurysms, it remains significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wrapping of intracranial aneurysms: Single-center series and systematic review of the literature. Perrini, P., Montemurro, N., Caniglia, M., et al.[2018]

Infusing gold nanoparticles (AuNPs) into polymeric perivascular wraps significantly improves their visibility on imaging (radiopacity) without affecting their ability to enhance arteriovenous fistula (AVF) maturation, as shown in a study with Sprague Dawley rats.

The study demonstrated that both AuNP-infused and non-infused wraps effectively reduced vascular stenoses and inflammation markers, indicating that the addition of AuNPs does not compromise the therapeutic benefits of the wraps when seeded with mesenchymal stem cells (MSCs).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gold Nanoparticles for Monitoring of Mesenchymal Stem-Cell-Loaded Bioresorbable Polymeric Wraps for Arteriovenous Fistula Maturation. Barcena, AJR., Perez, JVD., Damasco, JA., et al.[2023]

In a study of 80 patients undergoing first-time arteriovenous fistula (AVF) creation, 78% had functioning AVFs after one month, indicating a generally high success rate for this vascular access method in hemodialysis.

Key predictors for a well-functioning AVF included a radial artery diameter greater than 2.3 mm, cephalic vein diameter greater than 2.7 mm, intraoperative mean flow above 113 mL/min, a pulsatility index (PI) less than 1.4, and postoperative mean flow exceeding 160 mL/min, which can guide early interventions for nonfunctioning AVFs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors predicting the successful function and use of autogenous arteriovenous fistulae for hemodialysis. Usta, E., Elkrinawi, R., Salehi-Gilani, S., et al.[2022]

The case study describes a successful treatment of a renal arteriovenous fistula (AVF) in a 40-year-old man using a homemade polytetrafluoroethylene covered Palmaz stent, marking one of the earliest reports of this method with a long follow-up period.

The use of covered stents for renal AVFs may offer advantages over traditional coil embolization, including lower costs, better preservation of kidney function, and a more straightforward procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The endovascular treatment of a renal arteriovenous fistula: Placement of a covered stent. Sprouse, LR., Hamilton, IN.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Gold Nanoparticles for Monitoring of Mesenchymal Stem Cell-Loaded Bioresorbable Polymeric Wraps for Arteriovenous Fistulas. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Rosuvastatin-Eluting Gold Nanoparticle-Loaded Perivascular Implantable Wrap for Enhanced Arteriovenous Fistula Maturation in a Murine Model. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Prospective, Multicenter, Observational Study to Evaluate a Cell-Impermeable Endoprosthesis for Treatment of Stenosis or Occlusion within the Dialysis Outflow Circuit of an Arteriovenous (AV) Fistula or AV Graft (The WRAP Registry). [2023]

4. United States pubmed.ncbi.nlm.nih.gov

How arteriovenous grafts could help to optimize vascular access management. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Bioresorbable Mesenchymal Stem Cell-Loaded Electrospun Polymeric Scaffold Inhibits Neointimal Hyperplasia Following Arteriovenous Fistula Formation in a Rat Model of Chronic Kidney Disease. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Wrapping of intracranial aneurysms: Single-center series and systematic review of the literature. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Gold Nanoparticles for Monitoring of Mesenchymal Stem-Cell-Loaded Bioresorbable Polymeric Wraps for Arteriovenous Fistula Maturation. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Risk factors predicting the successful function and use of autogenous arteriovenous fistulae for hemodialysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The endovascular treatment of a renal arteriovenous fistula: Placement of a covered stent. [2019]