DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis (Dragon)

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?

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis Access Failure; Arteriovenous Fistula; Angioplasty, Balloon
• Intervention / Treatment: Procedure: Endovascular therapy

Detailed Description

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 (Estimated): 180

Contacts and Locations

• Study Contact: Name: RuZhou Cao; Phone Number: +86 18616752813; Email: caorzh@126.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • First Affiliated Hospital of Zhengzhou University
      • Contact: Pei Wang, M.D.; Phone Number: +86-13523467291; Email: wangpei146@hotmail.com
      • Principal Investigator: Pei Wang, M.D.
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The Second Affiliated Hospital of Nanjing Medical University
      • Contact: XueQin Bian; Phone Number: +86-13914490638; Email: bianxueqin@njmu.edu.cn
      • Principal Investigator: Hong Ye
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Renji hospital
      • Principal Investigator: Lan Zhang, M.D.
      • Contact: RuZhou Cao; Phone Number: +86-18616752813; Email: caorzh@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Dysfunctional autogenous arteriovenous fistula patient: A stenosis in a hemodialysis access with significant hemodynamic changes: Based on angiography/ultrasound evaluation, the target lesion stenosis is ≥50%, and is accompanied by one or more of the following clinical and physiological abnormalities: natural fistula blood flow <480ml/min; unable to meet the required blood flow for the dialysis prescription; thrombosis in the autogenous arteriovenous fistula; elevated venous pressure during dialysis; difficult cannulation; decreased dialysis adequacy; and abnormal signs in the fistula, etc.

Description

Inclusion Criteria:

Subjects aged between 18 and 75 years. Subjects possess a mature upper limb autologous arteriovenous fistula (AVF) and have undergone at least one hemodialysis session.

Target lesion must be located in the venous segment of the upper limb AVF. Doppler ultrasound confirms that the target lesion stenosis is ≥50%, accompanied by at least one of the following clinical manifestations: elevated venous pressure during dialysis, abnormal fistula signs, significant reduction in blood flow (<200ml/min).

Guidewire and balloon successfully pass through the lesion and complete dilation. 6.Subjects or their legal representatives must understand the purpose of the trial, voluntarily participate in the clinical trial, and sign an informed consent form, while also being willing to adhere to the specific follow-up schedules set by this trial.

Exclusion Criteria:

Target lesion located in the arterial segment or anastomosis of the AVF. Target lesion located in the lower limb AVF. Subjects with previous stent implantation in the AVF. Patients diagnosed with symptomatic central venous occlusive disease: AVF flow reduction accompanied by swelling of the ipsilateral limb, chest, or facial area, with DSA confirmation of central venous occlusive disease.

Subjects with two or more target lesions in the AVF (when two stenoses are less than 3 cm apart, they are considered as one target lesion).

Subjects with acute thrombosis in the AVF or who have undergone AVF thrombolysis or thrombectomy within the past 30 days.

Subjects who have undergone or plan to undergo surgical intervention on the AVF within 30 days.

Subjects with AVF infection or concurrent systemic active infection. Subjects planning renal transplantation or switching to peritoneal dialysis within the next 12 months.

Subjects with diseases causing coagulopathy, such as thrombocytopenic purpura. Subjects undergoing immunotherapy or suspected/diagnosed with vasculitis. Subjects with allergies or contraindications to heparin or contrast agents. Subjects who are pregnant or breastfeeding. Subjects with a life expectancy of less than 12 months.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number 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.	1-month#3-month#6-month#12-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1-month#3-month#6-month#12-month

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Director: Hong Ye, The Second Hospital of Nanjing Medical University; Study Director: Pei Wang, the First Affiliated Hospital of Zhengzhou University; Principal Investigator: Lan Zhang, Shanghai Jiao Tong University School of Medicine，Renji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: The Dragon Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No