105 Participants Needed

InnAVasc Graft Implant for Kidney Failure

Recruiting at 13 trial locations
CN
SM
BL
HK
Overseen ByHarrison Kelner
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: InnAVasc Medical, Inc.
Must be taking: Antiplatelet therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the InnAVasc Graft Implant treatment for kidney failure?

The research suggests that arteriovenous grafts (AVGs) like the InnAVasc Graft are used in patients with kidney failure for hemodialysis access, and while they may have a higher initial catheter dependence compared to arteriovenous fistulas (AVFs), they offer a viable option for patients needing quick access. Additionally, early cannulation AVGs, such as the Acuseal, are noted for their advantages in early use, which may imply potential benefits for the InnAVasc Graft as well.12345

Is the InnAVasc Graft generally safe for humans?

The InnAVasc Graft, like other arteriovenous grafts, can have complications such as infections, which can be serious. Smoking may increase the risk of complications and failure of these grafts.12367

How is the InnAVasc Graft treatment different from other treatments for kidney failure?

The InnAVasc Graft is unique because it is designed to improve vascular access for dialysis in patients who may not have suitable veins for traditional arteriovenous fistulas, potentially offering a more reliable option for those with challenging vascular conditions.148910

What is the purpose of this trial?

The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are:Primary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months.Primary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months.Participants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.

Research Team

JR

John Ross, MD

Principal Investigator

MUSC Health Dialysis Access Institute

Eligibility Criteria

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.
See 3 more

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.
See 18 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Experimental: InnAVasc AVG treatmentExperimental Treatment1 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)

Find a Clinic Near You

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

Findings from Research

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.
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 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.
Catheter Dependence After Arteriovenous Fistula or Graft Placement Among Elderly Patients on Hemodialysis.Lyu, B., Chan, MR., Yevzlin, AS., et al.[2021]
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.
How to treat arteriovenous graft infection: total versus partial graft excision.Kim, SM., Min, SK., Ahn, S., et al.[2018]

References

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. [2020]
Catheter Dependence After Arteriovenous Fistula or Graft Placement Among Elderly Patients on Hemodialysis. [2021]
How to treat arteriovenous graft infection: total versus partial graft excision. [2018]
Early cannulation arteriovenous graft (Acuseal) versus standard arteriovenous graft in patients with end-stage renal disease. [2021]
Arteriovenous access outcomes in haemodialysis patients with HIV infection. [2016]
Smoking is associated with a higher complication and failure rate in arteriovenous grafts for haemodialysis: A multi-centre experience. [2023]
Infection of hemodialysis arteriovenous grafts. [2019]
Vascular access for haemodialysis with autogenous vein graft arteriovenous fistulas. [2004]
Axillary loop grafts for hemodialysis access: midterm results from a single-center study. [2012]
Inferiority of arteriovenous grafts, in comparison to autogenous fistulas, is underestimated by standard survival measures alone. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security