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

NCT06527963 | Recruiting DMC

• 1 other identifier: The Dragon Study
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

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. 1.Will drug-coated balloons achieve a better CD-TLR rate compared to cutting balloons?
2. 2.What medical problems do participants have when receiving treatment with drug-coated balloons or cutting balloons?

Conditions

Arteriovenous Fistula; Angioplasty, Balloon; Hemodialysis Access Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants with Target Lesion Primary Patency

  1-month#3-month#6-month#12-month

• Number of Participants with Target Lesion Assisted Primary Patency

  1-month#3-month#6-month#12-month

Interventions

Endovascular therapy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (3)

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Renji Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hong Ye

  The Second Hospital of Nanjing Medical University

  STUDY DIRECTOR

• Pei Wang

  The First Affiliated Hospital of Zhengzhou University

  STUDY DIRECTOR

• Lan Zhang

  Shanghai Jiao Tong University School of Medicine，Renji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RuZhou Cao

CONTACT

+86 18616752813; caorzh@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

CN (3)