Status:
UNKNOWN
Exploratory Research of PCSK9 Inhibitor on Patency of aAVF After PTA With PCB
Lead Sponsor:
RenJi Hospital
Conditions:
Hemodialysis Access Failure
Eligibility:
All Genders
17-76 years
Phase:
NA
Brief Summary
Autologous arteriovenous fistula (AVF) is the preferred vascular pathway type for maintenance hemodialysis (MHD) patients. The K/DOQI guidelines suggest that the use of percutaneous transluminal angio...
Eligibility Criteria
Inclusion
- Agree to join this study and sign an informed consent form
- Age ≥ 18 years old and ≤ 75 years old, regardless of gender
- Maintenance hemodialysis patients using autologous arteriovenous fistula (AVF), with a dialysis frequency of three times a week
- AVF venous stenosis: The local stenosis rate exceeds 50% of the normal diameter of nearby blood vessels and is accompanied by at least one of the following conditions:
- The natural blood flow of the internal fistula is less than 500ml/min or has decreased by more than 25% compared to the previous examination result
- Unable to meet the required blood flow for dialysis prescription (blood flow\<200ml/min, and cannot be corrected after adjusting the puncture needle position)
- Decreased arterial pressure or increased venous pressure during dialysis (monitoring arterial pressure\<-120mmHg for more than 2 consecutive times or monitoring venous pressure\>120mmHg while maintaining 200ml/min blood flow)
- Difficulty in puncture: A qualified nurse who has difficulty puncturing for 3 consecutive days of hemodialysis (blood can only be drawn out after more than two punctures)
- Decreased dialysis adequacy \[arteriovenous fistula recirculation rate (RA)\>10%, or an increase of more than 25% compared to the previous examination result\] \[RA=(SA-A)/(SA-V) \* 100, dialysis to 1 hour: SA=blood flow adjusted to 20ml/min, ultrafiltration and dialysate flow stopped, after 2 minutes, artery Blood urea nitrogen concentration A=artery Blood urea nitrogen concentration V=vein Blood urea nitrogen concentration\]
- Abnormal signs of fistula.
- Patients with primary Hypercholesterolemia \[LDL-C ≥ 130 mg/dl (≥ 3.4 mmol/L), and/or non-HDL-C≥ 160 mg/dl (≥ 4.1 mmol/L)\] or combine cardiovascular disease or assess patients with a high risk of cardiovascular disease
Exclusion
- MHD with AVG
- Breastfeeding or Pregnant Women
- Patients with central venous reflux obstruction
- Patients with AVF feeding artery disease
- Patients with severe Hypotension (systolic blood pressure\<90mmHg or diastolic blood pressure\<60mmHg, at least three times within one month before signing the informed consent)
- Left ventricular Ejection fraction less than 30% or hemodynamic instability
- Patients receiving immunotherapy or suspected/confirmed Vasculitis
- Patients with coagulation dysfunction or a history of Thrombocytopenic purpura
- Patients with vascular access infections or systemic active infections
- Patients who are known to be allergic to PCSK9 inhibitors or paclitaxel
- Patient's life expectancy is less than 12 months
- Patients who are planning kidney transplantation or switching to Peritoneal dialysis
- Patients participating in other intervention studies
- The researcher judged that the subject's condition was not suitable for participation in this study
Key Trial Info
Start Date :
September 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06034691
Start Date
September 10 2023
End Date
October 1 2024
Last Update
September 13 2023
Active Locations (1)
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1
Yuanyuan Xie
Shanghai, Pudong, China, 200127