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NCT07649083Not yet recruiting

Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients

Source: ClinicalTrials.gov · Last updated 16 Jun 2026

Brief summary (registry, in English)

Patients are randomly assigned to a study group. Depending on the study group, either an arteriovenous fistula or tunneled cuffed catheter (TCC) will be implanted, followed by continuous evaluation of the patients during the first year after initiating the vascular access. The evaluation includes statistical evaluation of all events, including loss of access, thrombosis, infection, loss of patency, increase in co-morbidities, e.g. congestive heart failure as well as quality of life. The implantation of the TCC is a standard procedure and it will be used only in accordance with the approved instructions of use on subjects who have signed an informed consent form. The surgery is a standard operation and it will be performed by specialized surgeons on subjects who have signed an informed consent form (No grafts will be used; implantation of a standard TCC, used at the Department of Nephrology). Both, an arteriovenous fistula or a TCC, will be used for routine chronic haemodialysis

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
220 (estimated)
First submitted
11 Jun 2026
Start date
1 Aug 2026
Primary completion date
31 Dec 2029
Lead sponsor
Medical University of Vienna
NCT number
NCT07649083

What you commit to

  • Study type: Interventional
  • Planned participants: 220
  • From 1 Aug 2026 to the primary completion date, 31 Dec 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Major surgery within 12 weeks before screening

Other illness

  • Poor overall health or malignancy not in remission at screening
  • Endovascular arteriovenous fistula

Lab values

  • Uncontrolled infection and/or CRP \>5 mg/dl (normal \<0.5 mg/dl) at screening

Other

  • Pre-existent vascular access
  • Patient not eligible for any one of the vascular access options

Who the study is looking for

  • Aged ≥60 years or \<60 years with a CCI Score \>6
  • Patients with CKD G5 A1-3 with indication for hemodialysis
  • Stable clinical condition
  • Eligibility for both arteriovenous fistula on the upper extremities and TCC
  • Availability for follow-up
  • Written informed consent

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.