Exploratory Research of PCSK9 Inhibitor on Patency of aAVF After PTA With PCB

Launched by RENJI HOSPITAL · Sep 10, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a new treatment approach for patients with hemodialysis access failure, specifically focusing on improving the effectiveness of a procedure called angioplasty, which helps clear blockages in an access point known as an arteriovenous fistula (AVF). The researchers are investigating whether combining a special type of balloon treatment that releases medication (called a drug-coated balloon) with a new cholesterol-lowering medication (PCSK9 inhibitors) can help keep the AVF functioning better for a longer time after the procedure.

To participate in this study, individuals must be between 18 and 75 years old, be on maintenance hemodialysis using an AVF, and have specific issues related to their AVF, such as significant narrowing that affects blood flow. Participants can expect to receive close monitoring and follow-up care throughout the trial to assess the safety and effectiveness of the combined treatment. This study is currently recruiting, and it aims to provide valuable insights into improving the care of patients with hemodialysis access failure.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Agree to join this study and sign an informed consent form
• • 2. Age ≥ 18 years old and ≤ 75 years old, regardless of gender
• • 3. Maintenance hemodialysis patients using autologous arteriovenous fistula (AVF), with a dialysis frequency of three times a week
• 4. 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:
• • 1. 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
• • 2. Unable to meet the required blood flow for dialysis prescription (blood flow\<200ml/min, and cannot be corrected after adjusting the puncture needle position)
• • 3. 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)
• • 4. 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)
• • 5. Decreased dialysis adequacy \[arteriovenous fistula recirculation rate (RA)\>10%, or an increase of more than 25% compared to the previous examination result\] \[RA=(SA-A)/(SA-V) \* 100, dialysis to 1 hour: SA=blood flow adjusted to 20ml/min, ultrafiltration and dialysate flow stopped, after 2 minutes, artery Blood urea nitrogen concentration A=artery Blood urea nitrogen concentration V=vein Blood urea nitrogen concentration\]
• • 6. Abnormal signs of fistula.
• • 5. 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 Criteria:
• • 1. MHD with AVG
• • 2. Breastfeeding or Pregnant Women
• • 3. Patients with central venous reflux obstruction
• • 4. Patients with AVF feeding artery disease
• • 5. 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)
• • 6. Left ventricular Ejection fraction less than 30% or hemodynamic instability
• • 7. Patients receiving immunotherapy or suspected/confirmed Vasculitis
• • 8. Patients with coagulation dysfunction or a history of Thrombocytopenic purpura
• • 9. Patients with vascular access infections or systemic active infections
• • 10. Patients who are known to be allergic to PCSK9 inhibitors or paclitaxel
• • 11. Patient's life expectancy is less than 12 months
• • 12. Patients who are planning kidney transplantation or switching to Peritoneal dialysis
• • 13. Patients participating in other intervention studies
• • 14. The researcher judged that the subject's condition was not suitable for participation in this study