NCT06493292 Effectiveness of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
| NCT ID | NCT06493292 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Hemodialysis Access Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-12 |
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 180 participants in total. It began in 2024-06-01 with a primary completion date of 2025-12.
⚠ 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 comparing the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous segment stenosis of autologous arteriovenous fistulas.This is a prospective, multi-center cohort study.
Eligibility Criteria
Inclusion Criteria: 1. Subjects aged between 18 and 75 years. 2. Subjects possess a mature upper limb autologous arteriovenous fistula (AVF) and have undergone at least one hemodialysis session. 3. Target lesion must be located in the venous segment of the upper limb AVF. 4. Doppler ultrasound confirms that the target lesion stenosis is ≥50%, accompanied by at least one of the following clinical manifestations: elevated venous pressure during dialysis, abnormal fistula signs, significant reduction in blood flow (\<200ml/min). 5. Guidewire and balloon successfully pass through the lesion and complete dilation. 6.Subjects or their legal representatives must understand the purpose of the trial, voluntarily participate in the clinical trial, and sign an informed consent form, while also being willing to adhere to the specific follow-up schedules set by this trial. Exclusion Criteria: 1. Target lesion located in the arterial segment or anastomosis of the AVF. 2. Target lesion located in the lower limb AVF. 3. Subjects with previous stent implantation in the AVF. 4. Patients diagnosed with symptomatic central venous occlusive disease: AVF flow reduction accompanied by swelling of the ipsilateral limb, chest, or facial area, with DSA confirmation of central venous occlusive disease. 5. Subjects with two or more target lesions in the AVF (when two stenoses are less than 3 cm apart, they are considered as one target lesion). 6. Subjects with acute thrombosis in the AVF or who have undergone AVF thrombolysis or thrombectomy within the past 30 days. 7. Subjects who have undergone or plan to undergo surgical intervention on the AVF within 30 days. 8. Subjects with AVF infection or concurrent systemic active infection. 9. Subjects planning renal transplantation or switching to peritoneal dialysis within the next 12 months. 10. Subjects with diseases causing coagulopathy, such as thrombocytopenic purpura. 11. Subjects undergoing immunotherapy or suspected/diagnosed with vasculitis. 12. Subjects with allergies or contraindications to heparin or contrast agents. 13. Subjects who are pregnant or breastfeeding. 14. Subjects with a life expectancy of less than 12 months.
Contact & Investigator
Hong Ye
STUDY DIRECTOR
The Second Hospital of Nanjing Medical University
Frequently Asked Questions
Who can join the NCT06493292 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 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 NCT06493292 currently recruiting?
Yes, NCT06493292 is actively recruiting participants. Contact the research team at caorzh@126.com for enrollment information.
Where is the NCT06493292 trial being conducted?
This trial is being conducted at Zhengzhou, China, Nanjing, China, Shanghai, China.
Who is sponsoring the NCT06493292 clinical trial?
NCT06493292 is sponsored by RenJi Hospital. The principal investigator is Hong Ye at The Second Hospital of Nanjing Medical University. The trial plans to enroll 180 participants.