Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
Purpose
A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.
Conditions
- Kidney Disease, End-Stage
- End-stage Renal Disease
- Arteriovenous Fistula
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subject must be either male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient to allow for completion of all study procedures. 2. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures. 3. Subject must be willing to comply with the protocol requirements, including clinical follow-up. 4. 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. 5. Target treatment vein diameter(s) for endoAVF creation ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Venography. 6. Target treatment artery diameter ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Arteriogram. 7. Subject has adequate collateral circulation to the hand, in the opinion of the Investigator. 8. At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the target creation site via a proximal forearm perforating vein.
Exclusion Criteria
- The subject is in a hypercoagulable state. 2. The subject has known bleeding diathesis. 3. The subject has insufficient cardiac output to support a native fistula in the opinion of the Investigator. 4. Known history of active intravenous drug abuse. 5. "Planned" major surgical procedure within 6 months following index procedure or major surgery within 30 days prior to index procedure. 6. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated. 7. The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated. 8. Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and/ or WBC of ≥ 12,000 cells/ μL, if collected). 9. 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. 10. The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies. 11. The subject has central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned endoAVF creation. 12. Absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via Duplex Ultrasound (DUS) or Venography. 13. Occlusion or stenosis > 50% of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via Duplex Ultrasound (DUS) or Venography. 14. Significantly compromised venous or arterial flow in the treatment arm as determined by Investigator and Duplex Ultrasound (DUS) or Venography. 15. Presence of significant calcification at the target endoAVF location that could potentially impact the effectiveness of endoAVF creation as determined by the Investigator.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental EndoAVF |
|
Recruiting Locations
California Institute of Renal Research
La Jolla 5363943, California 5332921 92037
La Jolla 5363943, California 5332921 92037
San Francisco Vein & Vascular
San Francisco 5391959, California 5332921 94117
San Francisco 5391959, California 5332921 94117
Radiology and Imaging Specialists
Lakeland 4161438, Florida 4155751 33801
Lakeland 4161438, Florida 4155751 33801
Vascular and Interventional Specialists
Miami 4164138, Florida 4155751 33156
Miami 4164138, Florida 4155751 33156
UMass Chan School of Medicine
Worcester 4956184, Massachusetts 6254926 01655
Worcester 4956184, Massachusetts 6254926 01655
Albany Medical Center
Albany 5106834, New York 5128638 12208
Albany 5106834, New York 5128638 12208
NC Nephrology
Raleigh 4487042, North Carolina 4482348 27609
Raleigh 4487042, North Carolina 4482348 27609
Butler Memorial Hospital
Butler 5182534, Pennsylvania 6254927 16001
Butler 5182534, Pennsylvania 6254927 16001
Bluff City Vascular
Memphis 4641239, Tennessee 4662168 38104
Memphis 4641239, Tennessee 4662168 38104
Houston Methodist
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
More Details
- NCT ID
- NCT04634916
- Status
- Recruiting
- Sponsor
- C. R. Bard