CKD Stage 3, CKD Stage 4, CKD Stage 5
Conditions
Keywords
CKD
Brief summary
This is an investigator-initiated post-marketing study that will evaluate use of the WaveLinQ system, a new and novel method of fistula creation using a percutaneous method in patients who require the creation of an arteriovenous fistula (AVF).
Detailed description
This investigator-initiated post-marketing study will evaluate use of the WaveLinQ system, a new and novel method of fistula creation, which uses a percutaneous method to create an AVF. Thirty male and female subjects with CKD 3-5 and who are clinical indicated for arteriovenous fistula (AVF) creation will be enrolled using the WaveLinQ device. Eligibility confirmation will be confirmed during screening up to 28 days from the index procedure. Subjects who are eligible will undergo fistula creation per standard institutional technique (index/baseline) and be followed at least monthly for 6 months per their standard of care plan. Primary, clinical and functional patency will be observed throughout the trial in addition to other data collection points per protocol. The expected total duration of subject participation from screening until the end of study is up to 7 months.
Interventions
DEVICEEndoAVF System for endovascular AV fistula creation
AV fistula creation
Sponsors
California Institute of Renal Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
primary end point
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or Female Age of at least 18 years 2. CKD 3 through 5 as measured by GFR 45 and under by MDRD equation on two separate occasions at least 3 months apart. 3. Provide written informed consent using a form that is approved by the Institutional Review Board (IRB) prior to collection of study data or performance of study procedures. 4. Currently not on hemodialysis. 5. Life expectancy of at least one year 6. Meets Anatomical Criteria for EndoAVF creation via pre-procedure Duplex or Venography Vascular anatomy suitable for creation of the AV fistula 7. Willing to comply with the specified follow-up evaluations
Exclusion criteria
1. Anatomical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | Interval of time from access placement until any intervention is undertaken to maintain or re-establish patency - 6 weeks | Successful endoAVF creation confirmed by intraprocedural angiography or duplex Ultrasound post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physiologically mature endoAVF at 6 months | 6 months | Percent of patients who did not require any intervention to be undertaken to maintain or re-establish patency |
Countries
United States
Contacts
Primary ContactOsman Khawar, MD
Backup ContactMichael Gastauer
Outcome results
None listed