A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV (DissolveAVF)

Evaluation of the Safety and Efficacy of the Peripheral Scoring Drug Balloon (Dissolve AV) in Treatment of Hemodialysis Arteriovenous Fistulae Stenosis A Prospective Multicenter Randomized Controlled Clinical Study

Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia, therefore, it represents an attractive option for AVF stenoses. This trial is aimed to evaluate the safety and efficacy of Peripheral scoring drug balloon (Dissolve AV) or Balloon Dilatation catheter ( Armada 35) in treating AVF stenosis in chinese population.

Study Overview

• Status: Completed
• Conditions: Fistulas Arteriovenous
• Intervention / Treatment: Device: Dissolve AVF; Device: Armada 35

Detailed Description

This is a prospective, multi-center, randomized controlled, open-label, superiority study. A total of 220 subjects will be enrolled from 11 sites in China. All subjects enrolled will be randomly assigned to the test group (Dissolve AV group, n=110) and the control group (Armada 35 group, n=110) with randomized allocation ratio of 1:1. Subjects in the test group and the control group will be treated with Peripheral scoring drug balloon or Balloon Dilatation catheter

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China
      • Tongren hospital, Capital medical university
    • Beijing, Beijing, China
      • Emergency General Hospital
  • Chongqing
    • Chongqing, Chongqing, China
      • The First Affiliated Hospital of Chongqing Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese
    • Shanghai, Shanghai, China
      • Huashan Hospital Affiliated to Fudan University
    • Shanghai, Shanghai, China
      • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
  • Shanxi
    • Taiyuan, Shanxi, China
      • Taiyuan Central Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Shaoyifu hospital, zhejiang medical universiyt
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-75 years (inclusive), male or female;
2. Patients with mature AVF/AVG and at least one successful hemodialysis session;
3. Target lesion located in the AVF/AVG reflux vein (excluding the feeding artery and central vein);
4. With hemodynamically significant AVF/AVG stenosis and meeting two of the following conditions (A & B) A. ≥ 50% stenosis of the target lesion as assessed by angiography B. Presence of at least one of the following (as defined in the NKF-K/DOQI guidelines) 1)Significantly elevated venous pressure during dialysis 2)Unexplained decrease in dialysis dose 3)Decrease in pump-controlled blood flow;
5. De novo or restenotic target lesion consisting of one or more tandem lesions, and with a visual reference vessel diameter of 4.0-8.0 mm and a total length ≤ 40 mm for the target lesion;
6. All non-target lesions must have <50% stenosis without clinical indication for treatment.
7. Patients who have signed the informed consent form.

Exclusion Criteria:

1. Patients who are participating in another clinical trial of a drug product or medical device;
2. Patients previously enrolled in this trial;
3. Women of childbearing age with a non-negative pregnancy test prior to surgical procedure, or lactating women;
4. Patients treated with major surgeries (e.g., open-heart surgery, cranial surgery) within 30 days prior to enrollment in the study;
5. Immature AVF/AVG (not subjected to dialysis; this vascular access has not been subjected to a single successful dialysis due to insufficient inner diameter that prevents successful puncture and results in inadequate blood flow);
6. Calcified lesions that are not expected to be dilated with a balloon;
7. AVF/AVG implanted with a stent;
8. AVF/AVG lesions previously treated with DCB;
9. Target lesions located at the venous anastomosis of AVF/AVG;
10. Impaired central venous reflux ;
11. Presence of a stenotic lesion in the artery that severely interferes with blood flow;
12. Patients with known allergy or intolerance to paclitaxel or contrast agent;
13. Patients with a life expectancy of less than 1 year;
14. Patients with concomitant systemic lupus erythematosus (SLE), ANCA-associated small vessel vasculitis;
15. Patients with a history of coagulopathy or thrombocytopenic purpura;
16. Patients treated with or scheduled to be treated with renal transplant or who have switched to peritoneal dialysis;
17. Vascular access infections or active systemic infections;
18. Presence of other medical conditions considered ineligible for the study as assessed by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dissolve AVF Group; This group treated with Peripheral scoring drug balloon.Dissolve AVF	Device: Dissolve AVF; Subjects in the test group will be treated with peripheral scoring drug balloon.; Other Names: Using Peripheral scoring drug balloon catheter to cover the whole treated segment
Active Comparator: PTA Group; This group treated with plain balloon catheter.Armada 35	Device: Armada 35; Subjects in the test group will be treated with plain balloon catheter.; Other Names: Using plain balloon catheter to cover the whole treated segment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion primary patency (TLPP) at 6 months post-procedure	TLPP ends with postoperative target lesion (including 5 mm proximal and 5 mm distal to the target lesion) failure (TLF) or target lesion-associated vascular access thrombosis. TLF is defined as the presence of at least one clinical symptom of inadequate dialysis blood flow (as defined in the NKF-K/DOQI guidelines) due to stenosis of the target lesion (≥ 50% stenosis of the target lesion on imaging), including significantly elevated venous pressure during dialysis, abnormal physical examination findings, and a decrease in pump-controlled blood flow.	6 month post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion primary patency (TLPP) at 12 months post-procedure	TLPP ends with postoperative target lesion (including 5 mm proximal and 5 mm distal to the target lesion) failure (TLF) or target lesion-associated vascular access thrombosis. TLF is defined as the presence of at least one clinical symptom of inadequate dialysis blood flow (as defined in the NKF-K/DOQI guidelines) due to stenosis of the target lesion (≥ 50% stenosis of the target lesion on imaging), including significantly elevated venous pressure during dialysis, abnormal physical examination findings, and a decrease in pump-controlled blood flow.	12 Month post-procedure
Device success	When evaluated with a single balloon dilatation catheter, it is defined as successful reach of a target lesion, dilatation without rupture, and successful withdrawal.	0 day post-procedure
Procedural Success	It is defined as ≤ 30% residual stenosis of the target lesion, and the absence of serious perioperative adverse events.	0 day post-procedure
Clinical success	At least one session of successful hemodialysis following the procedure.	0 - 5 days post-procedure

Collaborators and Investigators

• Sponsor: DK Medical Technology (Suzhou) Co., Ltd.
• Investigators: Study Chair: YE CHAOYANG, ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Actual): October 2, 2021
• Study Completion (Actual): January 4, 2022

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Dialysis scoring Fistulas
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: VP-P-2018-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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