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Endovascular Fistula Creation System
EndoAVF Creation for Chronic Kidney Disease
N/A
Recruiting
Led By Osman Khawar, MD
Research Sponsored by California Institute of Renal Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trialwill study a new way to create an artery-vein connection (AVF) in patients who need it, using a percutaneous method.
Who is the study for?
This trial is for adults over 18 with chronic kidney disease stages 3 to 5, who are not on hemodialysis and have a life expectancy of at least one year. They must be willing to follow the study's procedures and have suitable vascular anatomy for creating an arteriovenous fistula (AVF). People with heart issues that affect blood flow, drug abuse history, clotting disorders, severe allergies to contrast media or sedation cannot participate.
What is being tested?
The STEP Study is testing the WaveLinQ system—a new method for creating AV fistulas without traditional surgery in pre-dialysis patients. It aims to evaluate its effectiveness as a less invasive option compared to conventional surgical methods.
What are the potential side effects?
Potential side effects may include reactions related to the procedure such as bleeding or bruising at the access site, infection risk, possible allergic reactions to contrast media used during imaging if pre-medication isn't effective, and discomfort from sedation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Procedure Success
Secondary study objectives
Physiologically mature endoAVF at 6 months
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: AVFExperimental Treatment1 Intervention
Single arm study using primary and secondary end points as comperators between subjects.
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Who is running the clinical trial?
California Institute of Renal ResearchLead Sponsor
3 Previous Clinical Trials
137 Total Patients Enrolled
Osman Khawar, MDPrincipal InvestigatorCalifornia Institute of Renal Research
1 Previous Clinical Trials
8 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart does not pump enough blood to support a natural fistula, according to the doctor's opinion.You have a history of using drugs through injection.You are allergic to the dye used for imaging tests and cannot take medication to prevent a reaction.You are expected to live for at least one more year.You are expected to require dialysis within the next 30 days.Your body does not meet the specific requirements for this study.You have previous bad reactions to sedation or anesthesia that cannot be managed with medication before the study.
Research Study Groups:
This trial has the following groups:- Group 1: AVF
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.
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