EndoAVF Creation for Chronic Kidney Failure

(CONNECT-AV Trial)

Recruiting at9 trial locations

Overseen by Eric Peden, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: C. R. Bard

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

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies the BD® WavelinQ™ EndoAVF System, a device that creates a connection between an artery and a vein. It is designed for patients who need dialysis. The device helps make a new pathway for blood flow, which is essential for the dialysis process.

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 data supports the idea that EndoAVF Creation for Chronic Kidney Failure is an effective treatment?

The available research does not provide any data on the effectiveness of EndoAVF Creation for Chronic Kidney Failure. The studies mentioned focus on different treatments and conditions, such as chronic lymphocytic leukemia and mantle cell lymphoma, and do not include information on EndoAVF Creation. ^{1 2 3 4 5}

What makes the BD WavelinQ EndoAVF System treatment unique for chronic kidney failure?

The BD WavelinQ EndoAVF System is unique because it creates an arteriovenous fistula (a connection between an artery and a vein) using a minimally invasive endovascular (inside the blood vessel) approach, which can be less invasive compared to traditional surgical methods for patients with chronic kidney failure. ^{6 7 8 9 10}

Research Team

Eric Peden, MD

Principal Investigator

The Methodist Hospital Research Institute

Paul Kreienberg, MD

Principal Investigator

Albany Medical College

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• BD® WavelinQ™ EndoAVF System (Endovascular Device)

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.

Participant Groups

Group I: EndoAVF Experimental Treatment 1 Intervention

BD® WavelinQ™ EndoAVF System is already approved in Canada for the following indications:

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

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Minimal Residual Disease Dynamics after Venetoclax-Obinutuzumab Treatment: Extended Off-Treatment Follow-up From the Randomized CLL14 Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Ibrutinib, obinutuzumab, and venetoclax in relapsed and untreated patients with mantle cell lymphoma: a phase 1/2 trial. [2021]

3. England 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. [2023]

4. United States 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. [2023]

5. Hungary pubmed.ncbi.nlm.nih.gov

[Venetoclax-based salvage in multiple myeloma with (11;14) translocation after suboptimal response to first-line therapy]. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

New generation shock wave lithotripsy. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

[Shock wave lithotripsy in Germany: Results of a nationwide survey]. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Development and testing of second generation extracorporeal shock-wave lithotriptor. [2019]

10. United States 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. [2018]