N/A
N=26
Catheter System Feasibility Clinical Trial
Renal Insufficiency, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT02816398 ↗Enrolled (actual)
26
Serious AEs
39.1%
Results posted
Aug 2020
Primary outcome: Primary: Number of Participants With Sufficient Patency for Clinical Access — 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Percutaneous creation of an arteriovenous fistula (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sufficient Patency for Clinical Access |
20 | — |
| PRIMARY Number of Patients Achieving Dialysis Access |
1 | — |
| PRIMARY Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis |
20 | — |
| SECONDARY Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access |
23 | — |
Summary
Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access.
Eligibility Criteria
Inclusion Criteria
- Patients deemed medically eligible for AV fistula creation per institutional guidelines and/or clinical judgment
- Patients diagnosed with chronic kidney disease classification stage IV or V
- Adequate quality vein >= 2 mm with confirmed clinically significant outflow based on pre-operative assessment
- Adequate quality radial artery >= 2 mm based on pre-operative assessment
- Adequate collateral arterial perfusion
- Radial artery-adjacent vein proximity < = 1.5 mm
- Able to provide informed consent
- Able to travel to institution for follow up examination
- Able to intraoperatively place an .014" guidewire in artery
Exclusion Criteria
- Suspected skin disease
- Immunocompromised patients (e.g. HIV positive)
- Edema of extremities
- Current diagnosis of carcinoma
- Pregnancy or currently breast feeding
- Diagnosed hypercoaguable state
- Active infection
- Evidence of vascular disease at target site
- Pre-existing vascular disease that could confound study results
- Vessel tortuosity or spasm preventing placement of .014" guidewire
Data sourced from ClinicalTrials.gov (NCT02816398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.