SelfWrap for Chronic Kidney Disease

(SAVE-FistulaS Trial)

Recruiting at 25 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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a treatment called SelfWrap, a wrap that dissolves in the body, to determine its effectiveness for people with chronic kidney disease (CKD) receiving a new arteriovenous fistula (AVF). An AVF is a surgical connection that aids in dialysis. The trial will compare patients receiving SelfWrap during surgery with those undergoing surgery without additional treatment. Individuals referred for a new AVF and able to adhere to the study guidelines for three years are suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance dialysis outcomes.

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 prior data suggests that SelfWrap is safe for chronic kidney disease patients?

Research shows that SelfWrap, a special wrap that dissolves in the body, is being tested for safety and effectiveness in people with chronic kidney disease. Specific safety results for SelfWrap are not yet available, but its inclusion in a clinical trial indicates promise in earlier lab or animal studies. The trial is in the "Not Applicable" phase, indicating early stages of human testing for this use. This suggests some initial safety information exists, but further confirmation is needed to ensure safety for people. If SelfWrap were unsafe, it would not be permitted in human trials. Consulting a healthcare professional before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SelfWrap for chronic kidney disease because it introduces an innovative bioabsorbable perivascular wrap during the creation of an arteriovenous fistula (AVF). Unlike standard procedures that don't involve any additional intervention after AVF creation, SelfWrap offers a new approach by potentially enhancing the stability and functionality of the AVF. This technique could lead to better outcomes for patients needing dialysis by improving blood flow and reducing complications associated with AVF procedures.

What evidence suggests that SelfWrap is effective for chronic kidney disease?

In this trial, participants will join one of two arms. Research has shown that SelfWrap, a special wrap that dissolves in the body, may improve the success of arteriovenous fistulas (AVFs) for people with chronic kidney disease (CKD). This wrap aims to lower the chance of AVF failure by supporting blood vessels during healing. Early results suggest that SelfWrap can prevent common issues that cause AVFs to fail. It appears to work by maintaining good blood flow and reducing the risk of blockages. While these findings are encouraging, further research is needed to confirm all its benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

Timothy Boire, PhD

Principal Investigator

VenoStent, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06001827

the SelfWrap-Assisted ArterioVEnous Fistulas Study This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula ( ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20586080

the SelfWrap-Assisted ArterioVEnous Fistulas Study This is a prospective, randomized, multi-center clinical trial for chronic kidney ... effectiveness of SelfWrap, a bioabsorbable perivascular wrap. Participation ...

3. trialstoday.org trialstoday.org/trial/NCT06001827

the SelfWrap-Assisted ArterioVEnous Fistulas Study This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula ( ...

4. renalinterventions.net renalinterventions.net/novel-bioabsorbable-perivascular-wrap-aims-to-reduce-avf-failure/

Novel bioabsorbable perivascular wrap aims to reduce ... Another benefit of SelfWrap, according to Dillavou, is that it is able to circumvent the primary outcome contributing to a failure rate of over ...

5. withpower.com withpower.com/trial/phase-kidney-diseases-9-2023-c33f0

SelfWrap for Chronic Kidney Disease (SAVE-FistulaS Trial) Trial Overview The study compares the safety and effectiveness of a new bioabsorbable wrap called SelfWrap applied around an AVF, versus standard care without ...

6. clinicaltrialsarena.com clinicaltrialsarena.com/news/venostent-raises-20m-in-series-a-to-develop-bioabsorbable-perivascular-wrap/

VenoStent raises $20m in Series A to develop ... SelfWrap is designed to improve the usability and durability of arteriovenous fistulas (AVFs) created to enable haemodialysis treatment in ...