The purpose of this clinical trial is to compare the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous stenosis of autologous arteriovenous fistulas.The main questions it aims to answer are: 1. Will drug-coated balloons achieve a better CD-TLR rate compared to cutting balloons? 2. What medical problems do participants have when receiving treatment with drug-coated balloons or cutting balloons?
The study will recruit 180 patients with venous segment stenosis of autologous arteriovenous fistulas at multiple centers from June 2024 to December 2025. Patients will be divided into two cohorts based on the treatment method: the Cutting Balloon group and the Drug-Coated Balloon group. The primary outcomes observed will be the primary patency rates of the target lesion at 1, 3, 6, and 12 months post-operation, re-intervention rates of the target vessel, and the technical success rates and procedural success rates of the two devices, along with major adverse events during the perioperative period.
Study Type
OBSERVATIONAL
Enrollment
180
Endovascular therapy is a minimally invasive interventional approach that utilizes the vascular system as a pathway to access and treat various pathological conditions within the body. By employing specialized catheters and devices, endovascular techniques enable precise delivery of therapeutic agents or interventional procedures directly to the target site, without the need for conventional open surgery.
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGThe Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGRenji Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of Participants with Clinically-driven Target Lesion Re-intervened
Clinically-driven target lesion re-intervention refers to a repeat procedure performed on a previously treated lesion due to the recurrence of symptoms or other clinical indications, rather than being routinely scheduled.require reintervention after surgery, including: 1) clinically driven target lesions reintervention; 2) target lesion thrombosis; 3) surgery to remove the target lesion; 4) AVF waste caused by the target lesion can't treatment again.
Time frame: 1-month#3-month#6-month#12-month
Number of Participants with Target Lesion Primary Patency
Target lesion primary patency refers to the treated lesion site remaining open and unobstructed without the need for any additional revascularization procedure during the follow-up period.
Time frame: 1-month#3-month#6-month#12-month
Number of Participants with Target Lesion Assisted Primary Patency
Target lesion assisted primary patency refers to the treated lesion site remaining patent (open) during the follow-up period, but requiring an additional revascularization procedure, such as percutaneous transluminal angioplasty, to maintain patency of the target lesion.
Time frame: 1-month#3-month#6-month#12-month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.