NCT06470646 Effectiveness and Health Economics of Endoluminal Treatment of Arteriovenous Graft Fistula.
| NCT ID | NCT06470646 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Hemodialysis Access Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2025-05-31 |
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 240 participants in total. It began in 2023-09-01 with a primary completion date of 2025-05-31.
⚠ 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 is a prospective, single-center real-world research, aiming to understand the clinical intervention effects and health economics value of various endovascular treatment methods for arteriovenous graft fistula failure in the real world. The target lesion is defined as the inflow tract (artery, anastomosis, bend), middle segment, and outflow vein of the dialysis pathway. The study will recruit 240 patients with arteriovenous graft fistula failure at a single center from September 2023 to December 2024. Depending on different treatment methods, patients will be divided into several subgroups, such as the simple balloon dilation group, drug balloon group, stent implantation group, etc. As this is a real-world study, the main observations will be the technical success rate of various endovascular treatment methods, major adverse events during the perioperative period, and the symptom-driven target lesion re-intervention rate, target vessel patency rate, and total hospital expenditure related to target lesions at 1, 6, 12, 18, and 24 months postoperatively.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 to 80 years undergoing hemodialysis; 2. Patients with arteriovenous graft fistula unable to complete hemodialysis; 3. The guidewire must pass through the stenosis of the lesion side's graft fistula and further undergo endovascular treatment to be eligible for inclusion. This study does not limit the form of guidewire passing through the target lesion; 4. Patients who have successfully undergone endovascular treatment again after the initial target lesion opening failure are still eligible for inclusion; 5. Subjects and their legal representatives understand the purpose of the study, voluntarily participate, and sign informed consent forms, willing to undergo follow-up at specific time points in this trial. 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
JiaQuan Chen, M.M.
PRINCIPAL INVESTIGATOR
RenJi Hospital
Frequently Asked Questions
Who can join the NCT06470646 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 NCT06470646 currently recruiting?
Yes, NCT06470646 is actively recruiting participants. Contact the research team at caorzh@126.com for enrollment information.
Where is the NCT06470646 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06470646 clinical trial?
NCT06470646 is sponsored by RenJi Hospital. The principal investigator is JiaQuan Chen, M.M. at RenJi Hospital. The trial plans to enroll 240 participants.