Vascular Stent for Arteriovenous Fistula

Not currently recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: C. R. Bard

Disqualifiers: Av graft, Lower extremity access, Infection, Bleeding disorder, others

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

Compensation: Varies

Number of Visits: 1

Duration: At time of index procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the real-world safety and effectiveness of the COVERA Vascular Covered Stent, designed to treat stenosis in the veins of individuals using an arteriovenous (AV) fistula for dialysis. It may benefit those with a successfully used AV fistula who face issues from narrowing veins in the upper arm. For individuals fitting this profile, the trial might provide a new treatment option. As an unphased trial, it offers a unique opportunity to contribute to understanding the treatment's impact in real-world settings.

Will I have to stop taking my current medications?

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

What prior data suggests that this vascular stent is safe for treating stenotic lesions in the AV access circuit?

Research has shown that the Covera Vascular Covered Stent is generally safe. For example, one study found that 96.4% of patients did not experience major safety issues within the first 30 days after treatment. Another study demonstrated that the stent outperformed standard procedures, particularly in maintaining open blood vessels for a longer duration. These findings suggest that patients usually tolerate the stent well. Overall, the evidence supports its safety and effectiveness for treating narrowed blood vessels in individuals with arteriovenous fistulas, commonly used for dialysis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Covera Vascular Covered Stent is unique because it offers a new approach to treating stenotic lesions in the venous outflow of arteriovenous fistulas, which are critical for hemodialysis patients. Unlike traditional balloon angioplasty, which is commonly used to manage these lesions, the Covera stent is designed to provide a long-lasting solution by physically propping open the blood vessel and reducing the risk of restenosis. Researchers are excited about this treatment because it has the potential to improve the durability and effectiveness of AV fistula repairs, which could lead to fewer interventions and better quality of life for patients undergoing dialysis.

What evidence suggests that the COVERA Vascular Covered Stent is effective for treating stenotic lesions in the upper extremity venous outflow of the arteriovenous access circuit?

Research has shown that the COVERA Vascular Covered Stent, which participants in this trial will receive, effectively treats narrow sections in blood vessels used for dialysis. Studies have confirmed its safety and effectiveness in improving blood flow in the arm for patients with an arteriovenous (AV) fistula. Results from six-month follow-ups indicate that the stent performs well and surpasses standard balloon procedures (PTA) in treating these narrowings. This means the stent helps keep the blood vessels open more effectively, which is crucial for people undergoing dialysis. ^{1 2 3 4 6}

Who Is on the Research Team?

Bart Dolmatch, M.D.

Principal Investigator

The Palo Alto Medical Foundation

Are You a Good Fit for This Trial?

This trial is for adults over 21 with arteriovenous fistulas in the upper extremity used for dialysis, who've had at least one successful session. Participants must have a vein size of 5.0-9.0mm and a stenosis ≥50% causing dysfunction. Exclusions include lower extremity AV access, allergies to certain metals or contrast media, recent thrombosis treatment, uncontrolled infections or bleeding disorders.

Inclusion Criteria

I have a working AV fistula in my arm that has been used for dialysis.

I am at least 21 years old, not pregnant (if female), and expected to live long enough to complete the study.

The nearby vein must be between 5.0 and 9.0mm wide.

Exclusion Criteria

My dialysis access is in my leg.

I have untreated narrow veins far from the main problem area.

The area to be studied is inside a stent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the AV access circuit

At time of index procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Visits at 1, 3, 6, 12, 18, 24, and 36 months post index procedure

What Are the Treatments Tested in This Trial?

Interventions

• Covera Vascular Covered Stent

Trial Overview The study aims to gather safety and effectiveness data on the COVERA Vascular Covered Stent when treating narrowed blood vessels in venous outflow from arteriovenous (AV) access circuits in patients undergoing hemodialysis.

How Is the Trial Designed?

Group I: COVERA Vascular Covered Stent Experimental Treatment 1 Intervention

COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of hemodialysis subjects dialyzing with an AV fistula.

Who Is Running the Clinical Trial?

C. R. Bard

Lead Sponsor

Trials

109

Recruited

40,200+

Timothy M. Ring

C. R. Bard

Chief Executive Officer since 2003

Bachelor of Science in Industrial and Labor Relations from Cornell University

Dr. Cimler

C. R. Bard

Chief Medical Officer since 2017

Ph.D. in Pharmacology

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39789255/

Six-Month Outcomes from the Prospective, Multi-Center, ... Conclusion: The 6-month results of the AVeNEW PAS confirm results from the AVeNEW IDE clinical trial and demonstrate safety and efficacy using ...

2. link.springer.com link.springer.com/article/10.1007/s00270-024-03930-7

Six-Month Outcomes from the Prospective, Multi-Center, ... The 6-month results of the AVeNEW PAS confirm the safety and efficacy results from the AVeNEW IDE utilizing the Covera(™) Vascular Covered Stent ...

3. bd.com bd.com/content/dam/bd-assets/na/peripheral-intervention/web-assets/us/documents/bd-93961_2023-covera-clinical-update.pdf

Annual Clinical Update The results of the AVeVA study demonstrated that the. Covera™ Vascular Covered Stent is safe and effective in the treatment of stenotic lesions at the graft- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02649946

NCT02649946 | Clinical Study of the BARD® COVERA™ ... The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170042S002B.pdf

summary of safety and effectiveness data (ssed) The results demonstrated that, with respect to. TLPP, the COVERA™ Vascular Covered Stent was superior to the PTA control (p <. 0.001) for treatment of stenoses ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1051044322000641

Prospective, Multicenter Clinical Study of the Covera ... Thirty-day freedom from a primary safety event was 96.4%, and 6-month target lesion primary patency was 70.3%. The end points were both superior to the ...