Actively Recruiting
Effectiveness and Health Economics of Endoluminal Treatment of Arteriovenous Graft Fistula.
Led by RenJi Hospital · Updated on 2024-06-24
240
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness and Health Economics of Endoluminal Treatment of Arteriovenous Graft Fistula.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years undergoing hemodialysis
- Patients with arteriovenous graft fistula unable to complete hemodialysis
- Guidewire must pass through the narrowed lesion of the graft fistula and undergo endovascular treatment
- Patients who have undergone endovascular treatment again after initial failure are eligible
- Patients and legal representatives understand the study, agree to participate, and sign consent forms with willingness to follow up
You will not qualify if you...
- Planned kidney transplant or switch to peritoneal dialysis
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Recent or planned surgical procedure for hemodialysis access within 30 days
- Allergy or contraindication to heparin, contrast media, or antiplatelet drugs
- Participation in another interfering clinical trial within the last 3 months
- History of coagulation or other blood disorders
- Other serious diseases shortening life expectancy to less than 2 years or less than 6 months
- Unable or unwilling to participate in the trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Renji Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
C
Cao Ruzhou
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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