NCT06454396 Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
| NCT ID | NCT06454396 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Hemodialysis Access Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 480 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 480 participants in total. It began in 2023-01-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study was aimed at evaluating the efficacy of different endovascular treatments for early and mid-stage clinical interventions in patients with autologous arteriovenous fistulae loss of function and the corresponding health economic value.
Eligibility Criteria
Inclusion Criteria: 1. Hemodialysis patients over 18 years of age and under 80 years of age 2. Autologous arteriovenous fistula cannot be used in patients completing haemodialysis 3. The guidewire must pass through at least the stenosis of the endovascular fistula on the side of the lesion and undergo further endovascular treatment before enrolment, and this study does not limit the form of the guidewire passing through the target lesion. 4. Patients who have failed to open the initial target lesion and are successful on a second attempt at endoluminal therapy may still be enrolled. 5. Subjects and their legal representatives are able to understand the purpose of the study, participate voluntarily and sign an informed consent form, and are willing to be followed up at specific points in time. Exclusion Criteria: 1. Planned kidney transplant or conversion to peritoneal dialysis 2. Women who are pregnant, breastfeeding or planning to become pregnant during the study period 3. Recent (within 30 days) or planned surgical procedure for haemodialysis access 4. Allergy or contraindication to heparin, contrast media, antiplatelet drugs 5. Patients who have participated in a clinical trial of a drug or other medical device that interferes with this clinical trial within the last 3 months. 6. Patients with a history of coagulation disorders or other haematological disorders 7. Patients with other conditions that may make the trial difficult or significantly shorten the patient's life expectancy (\<2 years), e.g. tumours, severe liver disease, cardiac insufficiency, etc., or patients with a life expectancy of less than 6 months. 8. Patients unable or unwilling to participate in this trial
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06454396 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hemodialysis Access Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06454396 currently recruiting?
Yes, NCT06454396 is actively recruiting participants. Contact the research team at a8600809@163.com for enrollment information.
Where is the NCT06454396 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06454396 clinical trial?
NCT06454396 is sponsored by RenJi Hospital. The trial plans to enroll 480 participants.