InnAVasc Graft Implant for Kidney Failure

Recruiting at 14 trial locations

Overseen By Harrison Kelner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InnAVasc Medical, Inc.

Must be taking: Antiplatelet therapy

Must not be taking: Investigational drugs

Disqualifiers: Severe cardiac disease, Uncontrolled diabetes, Severe peripheral arterial disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new implant called the InnAVasc Arteriovenous Graft. Designed for people with end-stage kidney failure, the graft provides reliable access for hemodialysis, a treatment that cleans the blood. The trial will monitor the graft's performance and any side effects for up to six months. Ideal participants are those with end-stage kidney disease who need a new or improved dialysis access option and can start or continue blood-thinning medication after graft implantation. Participants will attend regular follow-up appointments for up to two years to track their progress. As an unphased trial, this study offers patients a unique opportunity to contribute to the development of innovative solutions for dialysis access.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be able to continue or start antiplatelet therapy (medication to prevent blood clots) after the graft implant.

What prior data suggests that the InnAVasc Arteriovenous Graft is safe for hemodialysis access in patients with end-stage renal disease?

Research has shown that the InnAVasc arteriovenous graft has been tested for safety and effectiveness in patients requiring hemodialysis. A previous study assessed the graft's performance and safety in patients with kidney failure. Although researchers stopped that study early, it was designed to gather crucial information about any unusual reactions or problems related to the graft.

This trial is labeled as "Not Applicable" in terms of phase, indicating a focus on a treatment already known, rather than a new drug or device. This suggests limited data from multiple studies, but reaching this stage implies some prior evidence of safety. Researchers will closely monitor participants to quickly identify and address any issues related to the device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The InnAVasc arteriovenous graft is unique because it offers a new way to create vascular access for dialysis patients with kidney failure. Unlike traditional grafts, this graft is designed for easier surgical implantation, reducing complications and potentially improving blood flow efficiency. Its innovative design allows for a more stable and durable dialysis access point, which can lead to fewer interventions and a better quality of life for patients. Researchers are excited about this treatment because it could significantly enhance the safety and effectiveness of dialysis procedures compared to existing options.

What evidence suggests that the InnAVasc Graft is effective for hemodialysis access in kidney failure?

Research has shown that the InnAVasc arteriovenous graft (AVG), which participants in this trial will receive, improves dialysis access for people with end-stage kidney disease. This graft creates a reliable connection between an artery and a vein, crucial for effective dialysis. Early results suggest it may help maintain this access, reducing common problems like clotting or blockage that occur with other types of dialysis access. Although detailed data from past studies is limited, the graft aims to address these common issues and improve long-term dialysis success. ^{1 2 3 4 5}

Who Is on the Research Team?

John Ross, MD

Principal Investigator

MUSC Health Dialysis Access Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 with end-stage renal failure who need a new type of arteriovenous graft for hemodialysis. Candidates should have suitable anatomy for the implant, be able to start antiplatelet therapy, and not have severe cardiac issues, uncontrolled diabetes or hypertension, recent strokes, certain blood conditions, active infections or cancer treatments within the last year.

Inclusion Criteria

Able and willing to give informed consent

The surgeon thinks both the artery and vein are the right size, have good blood flow, and are suitable for the procedure.

My arm's structure allows for a specific type of graft without crossing the elbow.

Exclusion Criteria

I have had a stroke in the last 6 months.

I might have a blocked or narrowed vein where my graft is planned.

The distance from my elbow crease to my armpit is less than 18 cm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are surgically implanted with an InnAVasc Arteriovenous Graft (IG) for hemodialysis access

6 months

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of secondary patency and adverse events

24 months

Periodic follow-up visits and assessments

What Are the Treatments Tested in This Trial?

Interventions

• InnAVasc arteriovenous graft

Trial Overview The study tests the InnAVasc arteriovenous graft designed for immediate use in hemodialysis patients. It aims to reduce bleeding post-dialysis and protect against needle misplacement compared to standard dialysis grafts.

How Is the Trial Designed?

Group I: Experimental: InnAVasc AVG treatment Experimental Treatment 1 Intervention

Patients will be surgically implanted with an InnAVasc Arteriovenous Graft (IG) in the forearm or upper arm using standard vascular surgical techniques. The graft will be placed in a "straight" (soft "C") configuration in the upper arm, or looped configuration in the forearm (forearm loop) or upper arm (axillary loop).

InnAVasc arteriovenous graft is already approved in United States for the following indications:

Approved in United States as InnAVasc Graft for:

• Hemodialysis access in patients with end-stage renal disease (ESRD)

Who Is Running the Clinical Trial?

InnAVasc Medical, Inc.

Lead Sponsor

Trials

2

Recruited

130+

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 of 50 cases of arteriovenous graft (AVG) infection, total graft excision (TGE) was performed in 34 patients, while partial graft excision (PGE) was done in 16 patients, with PGE showing potential for preserving vascular access despite a higher risk of recurrent infections.

No life-threatening complications were reported in patients after either surgical method, indicating that both TGE and PGE can be safely performed, but careful postoperative management is essential, especially for those undergoing PGE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to treat arteriovenous graft infection: total versus partial graft excision. Kim, SM., Min, SK., Ahn, S., et al.[2018]

In elderly patients starting hemodialysis, creating an arteriovenous fistula (AVF) leads to greater initial catheter dependence compared to an arteriovenous graft (AVG), with 95.6% of AVF patients dependent on catheters at 1 month versus 92.5% for AVG patients.

However, over a longer period (up to 36 months), AVF patients showed lower long-term catheter dependence, with only 8.2% remaining catheter-dependent compared to 15.0% for AVG patients, indicating that while AVFs may require more initial catheter use, they offer better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter Dependence After Arteriovenous Fistula or Graft Placement Among Elderly Patients on Hemodialysis. Lyu, B., Chan, MR., Yevzlin, AS., et al.[2021]

In a systematic review of 16 randomized control trials involving 2011 patients, stent grafts significantly reduced the risk of failure in thrombosed or failing synthetic arteriovenous grafts compared to plain balloon angioplasty, with an odds ratio of 0.53.

Drug-eluting balloons (DEBs) and stent grafts were identified as the most promising interventions for salvaging these grafts, but further research is needed to fully understand the efficacy of DEBs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short Term Success of Treatments to Salvage Thrombosed or Failing Synthetic Arteriovenous Grafts in End Stage Renal Disease: A Systematic Review and Network Meta-Analysis of Randomised Controlled Trials. Nikolopoulos, GK., Yiallourou, AI., Argyriou, C., et al.[2020]

In a study of 27 patients undergoing arteriovenous axillary loop graft (AVALG) construction for hemodialysis access, the primary patency rate at 12 months was 51%, and the secondary patency rate at 18 months was 80%, indicating a reasonable effectiveness for long-term vascular access.

The main complications included infection, thrombosis, and stenosis, affecting 41% of patients, but the procedure had a low mortality rate and secondary interventions were performed with minimal additional morbidity, suggesting that AVALG is a viable option for patients with limited vascular access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Axillary loop grafts for hemodialysis access: midterm results from a single-center study. Jean-Baptiste, E., Hassen-Khodja, R., Haudebourg, P., et al.[2012]

HIV-positive patients experienced significantly worse outcomes with arteriovenous (AV) grafts, showing only 17% thrombosis-free survival at one year compared to 62% in HIV-negative controls, indicating a higher risk of graft failure.

Infection-free graft survival was also lower in HIV-positive patients, with a hazard ratio of 3.51, while outcomes for AV fistulas were similar between both groups, suggesting that fistulas may be a better option for dialysis in HIV-positive patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arteriovenous access outcomes in haemodialysis patients with HIV infection. Mitchell, D., Krishnasami, Z., Young, CJ., et al.[2016]

In a 3-year study of 55 arteriovenous grafts (AVGs) for hemodialysis, smoking was identified as a significant risk factor for poorer outcomes, leading to higher rates of graft thrombosis and reduced primary and secondary patency rates.

The primary patency rates at 6, 12, and 24 months were 55%, 45%, and 44%, respectively, indicating that smoking negatively impacts AVG performance, suggesting that smoking cessation strategies should be implemented to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking is associated with a higher complication and failure rate in arteriovenous grafts for haemodialysis: A multi-centre experience. Kler, A., Khambalia, H., Pondor, Z., et al.[2023]

In a study of 84 prosthetic arteriovenous grafts (AVG) inserted in 58 patients, 17.3% experienced one or more episodes of infection, with a notably higher infection rate of 50% for SynerGraft compared to 12% for PTFE grafts.

Thigh AVG had a higher infection rate (9 out of 37) compared to other sites, although this difference was not statistically significant; only one death was directly linked to AVG infection, highlighting the need for prompt intervention in cases of infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infection of hemodialysis arteriovenous grafts. Akoh, JA., Patel, N.[2019]

Acuseal arteriovenous grafts (AAVGs) allow for significantly faster first cannulation (median 3 days) compared to standard arteriovenous grafts (SAVGs) which take about 30 days, making them advantageous for early access in end-stage renal disease patients.

Despite the quicker cannulation, AAVGs show comparable primary, primary assisted, and secondary patency rates, as well as similar complication rates (thrombosis and infection) to SAVGs, indicating their safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early cannulation arteriovenous graft (Acuseal) versus standard arteriovenous graft in patients with end-stage renal disease. He, J., Zeng, Q., Lang, F., et al.[2021]

In a study involving nine patients who required arteriovenous fistulae for hemodialysis, nine autogenous vein grafts (AVG) were successfully used, demonstrating a potential solution for patients lacking suitable vessels.

However, three grafts failed within 3 to 14 months, and complications such as thrombosis and false aneurysms occurred, indicating that while AVG can be effective, they may also present significant risks and require careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular access for haemodialysis with autogenous vein graft arteriovenous fistulas. Lindfors, O., Eklund, B., Kock, B.[2004]

In a study of 470 arteriovenous fistulas (AVF) and 92 arteriovenous grafts (AVG) followed for up to 4 years, AVFs showed significantly better one-year assisted primary patency rates (75%) compared to AVGs (47%).

AVGs required 2.4 times more interventions per patient-year to maintain dialysis access than AVFs, indicating that AVFs are more reliable and require less maintenance over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inferiority of arteriovenous grafts, in comparison to autogenous fistulas, is underestimated by standard survival measures alone. Thwaites, SE., Holt, SG., Yii, MK.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03645681

Evaluating the Safety and Effectiveness of the InnAVasc ... The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis.

2. reporter.nih.gov reporter.nih.gov/search/YszFYtrOLkqa-8e0DgvHTw/project-details/9464034

Project Details - NIH RePORTER Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure Study, TERMINATED. Core NIH Project Number ...

3. ctv.veeva.com ctv.veeva.com/study/evaluating-the-safety-and-effectiveness-of-the-innavasc-graft-for-dialysis-access-in-patients-with-k

Evaluating the Safety and Effectiveness of the InnAVasc Graft ... The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for ...

4. trialx.com trialx.com/clinical-trials/listings/220606/a-study-to-evaluate-the-safety-and-effectiveness-of-the-innavasc-arteriovenous-graft-for-hemodialysis-access-in-patients-with-end-stage-renal-disease/

A Study to Evaluate the Safety and Effectiveness ... The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis ( ...

5. trials-api.montefioreeinstein.org trials-api.montefioreeinstein.org/node/413461

Evaluating the Safety and Effectiveness of the InnAVasc Graft for ... The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in ...