Exploratory Research of PCSK9 Inhibitor on Patency of aAVF After PTA With PCB (NCT06034691) | Clinical Trial Compass
UnknownNot Applicable
Exploratory Research of PCSK9 Inhibitor on Patency of aAVF After PTA With PCB
China40 participantsStarted 2023-09-10
Plain-language 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 angioplasty (PTA) as the primary treatment for AVF stenosis is reasonable. However, the durability of PTA is limited. In order to reduce the risk of dysfunction recurrence after the intervention, there have been reports in recent years that drug-coated balloons (DCB) are used in the treatment of vascular stenosis in hemodialysis. Multiple factors have limited the efficacy of DCB. Previous studies on the related factors of hemodialysis access stenosis showed that Dyslipidemia was significantly related to the short initial patency rate, and Dyslipidemia was an important predictor of secondary patency loss. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are a new type of lipid-lowering drug that can prevent vascular calcification. Previous studies have shown that PCSK9 inhibitors have good lipid-lowering effects in both MHD patients and nondialysis patients, and the use of PSK9 inhibitors at the same dose as nondialysis patients is safe in MHD patients. There are currently few studies on the use of paclitaxel-releasing balloon dilation combined with PCSK9 inhibitors to improve autologous internal fistula. Therefore, the investigators applied a prospective, randomized, and controlled study method to preliminarily explore the effect of paclitaxel releasing balloon combined with PCSK9 inhibitor on improving the postoperative patency rate of AVF and the safety of the combined application.
Who can participate
Age range
17 Years – 76 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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)
Exclusion criteria
. 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