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Endovascular Device
EndoAVF Creation for Chronic Kidney Failure (CONNECT-AV Trial)
N/A
Recruiting
Led By Eric Peden, MD
Research Sponsored by C. R. Bard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the target creation site via a proximal forearm perforating vein
Subjects who have established, non-reversible kidney failure, who are currently on dialysis at screening or are in immediate need (within 6 months of endoAVF creation) of dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Awards & highlights
CONNECT-AV Trial Summary
This trial is testing a new system for creating an AV fistula in patients who need dialysis.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, creating an AV fistula can sometimes lead to issues like clotting at the site, infection, arm swelling due to blood flow changes, or narrowing of the vessels.
CONNECT-AV Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a vein in my forearm that is at least 2.5 mm wide and connects to the target site.
Select...
I have permanent kidney failure and am on dialysis or will need it soon.
CONNECT-AV Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-weeks, 6-weeks, 3-, 6-, 12-, 18-, and 24-months post index procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Device- and procedure-related serious adverse events (SAE)
Secondary outcome measures
Assisted Primary Patency
CVC Exposure/Use
Cannulation Success
+9 moreCONNECT-AV Trial Design
1Treatment groups
Experimental Treatment
Group I: EndoAVFExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
C. R. BardLead Sponsor
103 Previous Clinical Trials
39,320 Total Patients Enrolled
6 Trials studying Arteriovenous Fistula
932 Patients Enrolled for Arteriovenous Fistula
Eric Peden, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
2 Previous Clinical Trials
290 Total Patients Enrolled
Paul Kreienberg, MDPrincipal InvestigatorAlbany Medical College
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of currently using drugs through a needle.I have a vein in my forearm that is at least 2.5 mm wide and connects to the target site.My blood clots more easily than normal.There is no vein in your forearm that connects to the vein we need to access for the procedure, as shown by a special kind of ultrasound or vein imaging.There is a lot of hardening in the area where the new blood vessel will be made, which could make it harder to create the new blood vessel.I have a condition that causes abnormal bleeding.The veins in your arm are at least 2.0 millimeters wide as shown in a Duplex Ultrasound or Venography.The doctor thinks your heart may not be strong enough to support a natural fistula.I have a narrowed vein by more than 50% where my endoAVF is planned.Your veins are more than 50% blocked in areas where the needle needs to be inserted, as checked by ultrasound or venography.I am 18 or older, not pregnant, and expected to live long enough to complete the study.My blood flow in the arm to be treated is significantly reduced, confirmed by tests.The artery being treated is at least 2.0 mm wide according to ultrasound or arteriogram measurements.My hand has good blood flow, as confirmed by my doctor.I have permanent kidney failure and am on dialysis or will need it soon.I haven't had major surgery in the last 30 days and don't plan any in the next 6 months.You have a fever or high white blood cell count on the day of the procedure, indicating an ongoing infection.
Research Study Groups:
This trial has the following groups:- Group 1: EndoAVF
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the population size of this clinical research study?
"Yes, according to clinicaltrials.gov this experiment is actively seeking participants and has been since March 26th 2021 when it was first posted online. It requires 280 individuals across 8 sites in order to fulfill the recruitment requirement with an update being made on May 23rd 2022."
Answered by AI
Is there availability for individuals to partake in this clinical experiment?
"According to the clinicaltrials.gov database, this experiment is recruiting participants. The trial was initially advertised on March 26th 2021 and has since been updated on May 23rd 2022."
Answered by AI
Are there any Canadian-based medical centers participating in this trial?
"In this clinical trial, 8 distinct medical facilities are participating in the recruitment process. These include Radiology and Imaging Specialists from Lakeland, Vascular and Interventional Specialists from Miami, University of Texas Health Science Centre at Houston in Saint Louis, plus 5 other sites."
Answered by AI
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