EndoAVF Creation for Chronic Kidney Failure

(CONNECT-AV Trial)

Recruiting at 9 trial locations

Overseen By Lindsay Downing

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: C. R. Bard

Disqualifiers: Hypercoagulable state, Bleeding diathesis, Active drug abuse, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with chronic kidney failure who require dialysis. The BD® WavelinQ™ EndoAVF System creates an arteriovenous fistula, a crucial connection between an artery and a vein for dialysis. The study aims to evaluate the system's effectiveness in real-world settings. Individuals with permanent kidney failure who are on dialysis or will need it soon may qualify for this trial. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance dialysis treatment for many.

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 the BD® WavelinQ™ EndoAVF System is safe for creating arteriovenous fistulas?

Research shows that the BD® WavelinQ™ EndoAVF System is generally well-tolerated by patients needing dialysis. This new system creates a connection between an artery and a vein using a less invasive method, often eliminating the need for open surgery.

However, users should be aware of some possible risks. Some patients with severe kidney disease have experienced issues like narrowing or blockage of the arteries, affecting blood flow in the treated area.

Despite these risks, studies closely monitor the technology after it becomes available on the market. This ongoing monitoring helps ensure that any problems are tracked and understood. While it's important to know about potential risks, overall evidence suggests that this system is a promising option for creating these connections with fewer complications than traditional methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The BD® WavelinQ™ EndoAVF System is unique because it offers a minimally invasive option for creating arteriovenous fistulas (AVFs) in patients with chronic kidney failure. Unlike traditional surgical methods, which require open surgery, this system uses an endovascular approach, meaning it can form a connection between an artery and a vein using a catheter and magnetic guidance. This could lead to less recovery time and fewer complications. Researchers are excited about this treatment as it has the potential to make the process of AVF creation safer and more accessible for patients, improving their quality of life.

What evidence suggests that the BD® WavelinQ™ EndoAVF System is effective for creating arteriovenous fistulas in patients with chronic kidney failure?

Research has shown that the BD® WavelinQ™ EndoAVF System, which participants in this trial will receive, effectively creates connections between blood vessels, known as arteriovenous fistulas (AVFs), for patients requiring dialysis. Studies have found that this system successfully creates these connections and maintains their function over time. It also offers more options for fistula placement, providing patients with additional treatment choices. Evidence suggests it serves as a safe alternative to traditional surgery. Overall, the BD® WavelinQ™ EndoAVF System has proven effective for patients with chronic kidney disease who need hemodialysis. ^{1 2 6 7 8}

Who Is on the Research Team?

Eric Peden, MD

Principal Investigator

The Methodist Hospital Research Institute

Paul Kreienberg, MD

Principal Investigator

Albany Medical College

Are You a Good Fit for This Trial?

This study is for adults over 18 with chronic kidney failure who are on dialysis or will need it within 6 months. They must have veins and arteries of certain sizes, be willing to follow the study plan, and not have any conditions that could interfere with the trial or reduce life expectancy.

Inclusion Criteria

I have a vein in my forearm that is at least 2.5 mm wide and connects to the target site.

The veins in your arm are at least 2.0 millimeters wide as shown in a Duplex Ultrasound or Venography.

Subject must be willing to comply with the protocol requirements, including clinical follow-up

Exclusion Criteria

You have a history of currently using drugs through a needle.

The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up

The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Index Procedure

Successful endoAVF creation and adjunctive procedures performed

1 day

Post-Procedure Monitoring

Participants are monitored for device- and procedure-related serious adverse events

4 weeks

Follow-up

Participants are monitored for patency and maturation of the endoAVF

24 months

What Are the Treatments Tested in This Trial?

Interventions

• BD® WavelinQ™ EndoAVF System

Trial Overview The BD® WavelinQ™ EndoAVF System is being tested in this study. It's a device used to create an arteriovenous fistula (a connection between an artery and vein) without traditional surgery, which patients needing dialysis require.

How Is the Trial Designed?

Group I: EndoAVF Experimental Treatment 1 Intervention

BD® WavelinQ™ EndoAVF System is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as WavelinQ EndoAVF System for:

• Creation of arteriovenous fistula (AVF) for hemodialysis in patients with chronic kidney disease

Approved in United States as BD WavelinQ EndoAVF System for:

• Creation of arteriovenous fistula (AVF) for hemodialysis in patients with chronic kidney disease

Approved in Canada as WavelinQ EndoAVF System for:

• Creation of arteriovenous fistula (AVF) for hemodialysis in patients with chronic kidney disease

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

Published Research Related to This Trial

Extracorporeal shock wave lithotripsy has been clinically successful for over 5 years, and the study presents results from the first 400 treatments using a new multifunctional urological table.

The prototype table allows for a new mode of shock wave generation and local coupling to the patient, enhancing the treatment process and integrating adjuvant endourological measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New generation shock wave lithotripsy. Wilbert, DM., Reichenberger, H., Noske, E., et al.[2019]

After a median follow-up of 46 months in the GLOW study, patients with untreated chronic lymphocytic leukaemia who received ibrutinib-venetoclax had a significantly better progression-free survival rate (74.6%) compared to those treated with chlorambucil-obinutuzumab (24.8%), indicating the efficacy of the ibrutinib-venetoclax combination as a first-line treatment.

While there were treatment-related deaths in both groups, the overall mortality was lower in the ibrutinib-venetoclax group (15 deaths) compared to the chlorambucil-obinutuzumab group (30 deaths), suggesting a potentially safer profile for the ibrutinib-venetoclax regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fixed-duration ibrutinib-venetoclax versus chlorambucil-obinutuzumab in previously untreated chronic lymphocytic leukaemia (GLOW): 4-year follow-up from a multicentre, open-label, randomised, phase 3 trial. Niemann, CU., Munir, T., Moreno, C., et al.[2023]

In the CLL14 study involving 432 patients, treatment with venetoclax and obinutuzumab (Ven-Obi) resulted in a significantly higher rate of undetectable minimal residual disease (MRD) at three months post-treatment (40% vs. 7% for chlorambucil and obinutuzumab), indicating better disease control.

Patients treated with Ven-Obi experienced a longer progression-free survival (PFS) with a median not reached compared to 36.4 months for those on chlorambucil, demonstrating superior long-term efficacy without new safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal Residual Disease Dynamics after Venetoclax-Obinutuzumab Treatment: Extended Off-Treatment Follow-up From the Randomized CLL14 Study. Al-Sawaf, O., Zhang, C., Lu, T., et al.[2022]

In the GLOW study, the combination of ibrutinib and venetoclax resulted in significantly higher rates of undetectable minimal residual disease (uMRD) in patients with chronic lymphocytic leukemia (CLL) compared to chlorambucil and obinutuzumab, with 40.6% and 43.4% achieving uMRD in bone marrow and peripheral blood, respectively, at 3 months after treatment.

Patients treated with ibrutinib and venetoclax maintained high progression-free survival (PFS) rates at 12 months, regardless of their MRD status, with rates of 96.3% for uMRD and 93.3% for detectable MRD, indicating that this treatment is effective even for those who do not achieve complete molecular remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Minimal Residual Disease on Progression-Free Survival Outcomes After Fixed-Duration Ibrutinib-Venetoclax Versus Chlorambucil-Obinutuzumab in the GLOW Study. Munir, T., Moreno, C., Owen, C., et al.[2023]

The Northgate SD-3 extracorporeal shock-wave lithotriptor demonstrated an 80% success rate in fragmenting kidney stones in an animal model, which improved to 87.5% after modifications to increase energy output.

The device features an accurate ultrasound-guided computer-assisted aiming system that can localize stones within 1 mm, effectively identifying both radiolucent stones and small fragments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and testing of second generation extracorporeal shock-wave lithotriptor. Begun, FP., Lawson, RK., Cauley, JE., et al.[2019]

Extracorporeal shock wave lithotripsy (SWL) remains a major treatment method for ureteral and renal stones in Germany, with a survey of 306 urological departments showing that it still holds its gold standard status.

The quality of SWL therapy in German hospitals is high, but to maintain this standard, ongoing training and adherence to clinical guidelines are essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Shock wave lithotripsy in Germany: Results of a nationwide survey]. Schnabel, MJ., Brummeisl, W., Burger, M., et al.[2022]

The Econolith shockwave lithotripsy system demonstrated a high average stone fragmentation rate of 86% after the first treatment, with 75% of patients being stone-free at 3 months.

The system is considered safe, with only 6% of patients experiencing minor complications, and its mobility and low cost make it accessible for urologists even in low-volume practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with 500 extracorporeal shockwave lithotripsy patients using a low-cost unit: the "Econolith". Simon, D.[2016]

In a study of 320 patients with solitary renal stones, different shockwave lithotripsy (SWL) protocols did not significantly reduce the incidence of renal hematoma, which occurred in 7.69% of cases overall.

Neither the ramping protocol nor the pause protocol showed any clear benefits in preventing renal injury compared to continuous high-power treatment, indicating that these modifications may not enhance safety during SWL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Randomized Study Comparing the Effect of Different Kidney Protection Treatment Protocols on Acute Renal Injury After Extracorporeal Shockwave Lithotripsy. Ng, CF., Luke, S., Yee, CH., et al.[2018]

In a study of 13 patients with multiple myeloma and the t(11;14) genetic abnormality, venetoclax therapy was highly effective as a second-line treatment, with all patients responding positively and 10 proceeding to stem cell transplantation.

Despite the presence of adverse prognostic markers in the patient group, such as del(17p) and stage 3 disease, the treatment led to significant responses, with 6 patients achieving very good partial response and 7 achieving complete response, indicating venetoclax's potential as a salvage therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Venetoclax-based salvage in multiple myeloma with (11;14) translocation after suboptimal response to first-line therapy]. Szita, VR., Wiedemann, Á., Syoreni, S., et al.[2023]

The combination of venetoclax, ibrutinib, and obinutuzumab is well tolerated in patients with relapsed and untreated mantle cell lymphoma (MCL), with no dose-limiting toxicities reported and a maximum tolerated dose of 400 mg per day established for venetoclax.

High response rates were observed, with a complete response rate of 67% in relapsed patients and 86.6% in untreated patients, along with significant minimal residual disease clearance in 71.5% of relapsed and 100% of untreated patients after three cycles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibrutinib, obinutuzumab, and venetoclax in relapsed and untreated patients with mantle cell lymphoma: a phase 1/2 trial. Le Gouill, S., Morschhauser, F., Chiron, D., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04634916

Post-market Surveillance Study of the BD® WavelinQ ... A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in ...

2. wavelinq.bd.com wavelinq.bd.com/proceduralist/approved_bd-11707_wavelinq-global-data-analysis_v1-0-1-21-20-2-2/

Global Data Analysis - WavelinQ Indications: The WavelinQ™ 4F EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or ...

3. news.bd.com news.bd.com/2018-02-13-BD-Advances-Technology-to-Create-Endovascular-AV-Fistulas-for-Chronic-Kidney-Disease-Patients-Who-Require-Hemodialysis

BD Newsroom - Press releases The BD WavelinQ™ 4F endoAVF system, with its slim profile, increases the anatomical AVF location options and enables additional venous wrist ...

4. academic.oup.com academic.oup.com/ckj/article/18/4/sfaf063/8043268

Comparative outcomes of surgical versus percutaneous ... The results of our study showed endoAVFs may be a safe and effective alternative to RC AVFs, showing high rates of technical success and patency.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949912724001119

Study protocol for a French multicenter randomized ... This study will compare the cost effectiveness of endovascular AVF creation using Ellipsys and WaveLinQ devices versus traditional surgical arteriovenous ...

6. wavelinq.bd.com wavelinq.bd.com/

WavelinQ™ EndoAVF System - Rethink Fistula Creation ... The WavelinQ™ EndoAVF System takes an innovative approach in creating endovascular AV fistula (endoAVF) for dialysis patients. Learn more within.

7. evtoday.com evtoday.com/articles/2019-oct-supplement/clinical-utility-of-the-wavelinq-endoavf-system

Clinical Utility of the WAVELINQ™ EndoAVF System This endovascular AVF (endoAVF) device consists of a dual magnetic catheter system with a venous and arterial catheter, which creates a fistula in the proximal ...

8. wavelinq.bd.com wavelinq.bd.com/nephrologist/

Nephrologists - Understanding WavelinQ™ EndoAVF ... - BD WavelinQ™ EndoAVF System is designed to provide a versatile, minimally invasive option for ESKD patients.