Collect data in an observational study on outcomes of endovascular fistula creation using the everlinQ endoAVF System
ID
Source
Brief title
Condition
- Nephropathies
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All subjects that undergo successful endoAVF creation will contribute to the
following outcome measures.
Primary Patency:
Time of successful endoAVF creation until any intervention designed to maintain
or reestablish patency or loss of endoAVF patency. The time to first
intervention will be calculated as the number of days between the date of
endoAVF creation and the date of either the first intervention, date of endoAVF
abandonment, or date of last follow-up where patency was evaluated, whichever
comes first.
Primary Assisted Patency:
Time interval of successful endoAVF creation until first thrombosis (at
endoAVF) causes loss of patency (thrombosis free survival). Interventions
employed to keep the fistula usable whether open or surgical (including new
anastomosis) do not affect this time.
Secondary outcome
Secondary Patency:
Total time from successful endoAVF creation to complete abandonment. All
subjects that undergo a successful endoAVF creation and do not have abandonment
due to renal transplant receipt will be included in the outcome measurement.
Cumulative Functional Patency:
The time period from first endoAVF cannulation (2 needle) to endoAVF
abandonment.
Procedure Success:
The successful endoAVF creation rate as assessed immediately post-procedure via
fistulogram, duplex ultrasound, or via presence of thrill/bruit. All subjects
that undergo the everlinQ procedure will contribute to this outcome measure.
Background summary
End Stage Renal Disease (ESRD) currently affects over 2 million people
worldwide. It is projected that the worldwide incidence of ESRD will increase
dramatically over the next 10 years, due to the increasing incidence of an
aging population, diabetes, hypertension, and obesity. Currently, Renal
Replacement Therapy for patients with ESRD consists of either hemodialysis or
peritoneal dialysis.
Vascular access is a critical component in the care of patients undergoing
hemodialysis. The three methods of long term vascular access available to a
patient requiring hemodialysis are: an autogenous arteriovenous fistula (AVF),
a prosthetic arteriovenous graft (AVG) or a tunneled dialysis catheter. The AVF
has been shown to be superior to AVG and superior to catheter access in terms
of both mortality and morbidity.
Though there is widespread agreement that the AVF is the preferred method of
vascular access, 28 - 60% of AVFs do not successfully mature and are rendered
unusable for hemodialysis. To improve on these results, and decrease the
invasiveness of the procedure, a new tool and method for creation of an AVF has
been developed, called everlinQ endoAVF System. In particular, the goal is to
reduce the surgical manipulation of the blood vessels, particularly the veins
in the arm, which typically exhibit intimal hyperplasia in surgical AVF.
Intimal hyperplasia is believed to be a root cause of failure in surgical AVF
and AVG, and this technology and method may help improve the patency and
maturity of AVF in patients with ESRD.
Study objective
Collect data in an observational study on outcomes of endovascular fistula
creation using the everlinQ endoAVF System
Study design
This is a prospective, multi-center study to evaluate the everlinQ endoAVF
System when used to create an endoAVF for patients who require vascular access
for hemodialysis.
The study may have up to 20 active sites participating in order to enroll up to
200 subjects that undergo successful endoAVF creation with the everlinQ endoAVF
System. All patients who meet study inclusion criterial and no exclusion
criteria will attempt to undergo the everlinQ procedure. Patients who undergo
the everlinQ procedure (catheter insertion and delivery of RF energy) will be
enrolled in the study. Patients who do not undergo the everlinQ procedure will
be treated per physician and hospital guidelines and will not be considered
enrolled in the study. Data outlining what kind of treatment the patients did
receive will be documented on the Screen Failure Log.
All subjects who undergo successful endoAVF creation using the everlinQ endoAVF
System will be followed for up to 12 months post index procedure.
Intervention
Creation of an endovascular arteriovenous fistula (endoAVF) with the everlinQ
endoAVF System for patients who require vascular access for hemodialysis.
Study burden and risks
Benefits:
The everlinQ endoAVF System may facilitate a less-invasive and more
reproducible AVF procedure while minimizing surgical incisions as compared to
conventional surgical AVF creation. This endovascular approach may lower the
risk of procedural infections as compared to surgical AVF creation. Due to the
less-invasive nature of the procedure with the everlinQ endoAVF System, the
endoAVF may exhibit improved maturation and patency characteristics compared to
historical maturation and patency data. In addition, patient recovery time may
be decreased, and anesthesia may be minimized compared to a conventional
surgical AVF procedure.
Risks:
Most of the potential risks and complications associated with the everlinQ
endoAVF System and procedure are similar to the risks expected for Chronic
Kidney Disease (CKD) patients undergoing surgically created AVF or AVG
procedures. The potential risks related to the everlinQ endoAVF System and
procedure include but not limited to:
• Aborted or longer procedure
• Additional procedures (interventions)
• Bleeding, hematoma (a solid swelling of clotted blood within the tissues) or
hemorrhage (an escape of blood from a ruptured blood vessel)
• Bruising
• Burns
• Death (mostly due to CKD related complications not the everlinQ endoAVF
device or procedure)
• Electrocution
• Failure to mature (AVF can never be used)
• Fever (pyrogenic reaction)
• Embolism (blood clot or device piece)
• Heart problems such as arrhythmias (abnormal beats) that can be caused due to
high levels of potassium in the blood (mostly due to CKD and not the TVA device
or procedure)
• Increased risk of congestive heart failure (heart fails due to increased flow
from AVF)
• Infection (local or in the blood (bacteremia))
• Numbness, tingling and/or coolness in the fistula extremity
• Occlusion/stenosis (AVF clots)
• Problem due to sedation or anesthesia
• Pseudoaneurysm (leaking hole in artery that forms blood clot on outside of it)
• Sepsis (systemic inflammatory reaction)
• Steal or ischemia (not enough blood flow to hand)
• Swelling, irritation or pain
• Thrombosis (AVF completely clotted and cannot be used)
• Toxic or allergic reaction
• Venous hypertension (arm swelling)
• Vessel, nerve or AVF damage or rupture
• Wound problem
In addition, fistula infiltration injury due to needle cannulation of the
fistula is also a known risk/event.
There may also be other potential risks related to use of the everlinQ endoAVF
System and procedure that are unforeseen at this time.
Minimization of Risk:
To minimize the risks, the everlinQ endoAVF System has undergone pre-clinical
testing. In addition, all Investigators participating in this clinical trial
will be trained on the everlinQ procedure which will contribute to minimizing
risks associated with the use of the device.
Qualified physicians trained on the study protocol will also utilize the
established eligibility criteria to select appropriate patients to participate
in the study.
Bee Cave Rd., Suite 250 7000
Austin, TX 78746
US
Bee Cave Rd., Suite 250 7000
Austin, TX 78746
US
Listed location countries
Age
Inclusion criteria
1. Adult (age >18 years old)
2. Established, non-reversible kidney failure requiring hemodialysis (stage 4 or 5 renal disease) including pre-dialysis patients
3. Target treatment vein diameter(s) for fistula creation >= 2.0 mm as measured via Duplex Ultrasound or Venogram
4. Target treatment artery diameter >= 2.0 mm as measured via Duplex Ultrasound of Arteriogram
5. Both radial and ulnar artery flow to the hand
Exclusion criteria
1. Known central venous stenosis or central vein narrowing > 50% based on imaging on the same side as the planned AVF creation
2. Absence of perforator feeding the target cannulation vein(s) via Venogram
3. Occlusion or stenosis >50% of target cannulation cephalic or basilic vein
4. Target cannulation vein that is >6 mm deep
5. Target cannulation vein that is <2.5 mm in diameter
6. Significantly compromised (>=50% stenosis) flow in the treatment arm as determined by physician and imaging
NOTE: patients that have >=50% arterial stenosis my undergo a Digital Brachial Index (DBI) test, if DBI result is <.65 patient is excluded
7. Documented ejection fraction (EF) <=35% in the last 6 months
8. Pregnant women
9. New York Heart Association (NYHA) class III or IV heart failure
10. Hypercoagulable state
11. Known bleeding diathesis
12. Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition
13. Documented history of drug abuse including intravenous drugs within six months of AVF creation
14. *Planned* concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment
15. Known allergy to contrast dye which cannot be adequately pre-medicated
16. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
17. Evidence of active infections on the day of the index procedure
18. Estimated life expectancy < 1 year
19. Patient is not willing to provide written informed consent, is not geographically stable and/or not willing to comply with required follow-up
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02682420 |
| CCMO | NL57371.068.16 |