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

NCT04226599 | Completed

• 1 other identifier: VP-P-2018-018
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Fistulas Arteriovenous

Keywords

Dialysis scoring Fistulas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Target lesion primary patency (TLPP) at 12 months post-procedure

  12 Month post-procedure

• Device success

  0 day post-procedure

• Procedural Success

  0 day post-procedure

• Clinical success

  0 - 5 days post-procedure

Study Arms (2)

Dissolve AVF Group

EXPERIMENTAL

This group treated with Peripheral scoring drug balloon.Dissolve AVF

Device: Dissolve AVF

PTA Group

ACTIVE COMPARATOR

This group treated with plain balloon catheter.Armada 35

Device: Armada 35

Interventions

Dissolve AVF DEVICE

Subjects in the test group will be treated with peripheral scoring drug balloon.

Also known as: Using Peripheral scoring drug balloon catheter to cover the whole treated segment

Dissolve AVF Group

Armada 35 DEVICE

Subjects in the test group will be treated with plain balloon catheter.

Also known as: Using plain balloon catheter to cover the whole treated segment

PTA Group

Eligibility Criteria

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

You may qualify if:

• Age 18-75 years (inclusive), male or female;
• Patients with mature AVF/AVG and at least one successful hemodialysis session;
• Target lesion located in the AVF/AVG reflux vein (excluding the feeding artery and central vein);
• 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;
• 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;
• All non-target lesions must have \<50% stenosis without clinical indication for treatment.
• Patients who have signed the informed consent form.

You may not qualify if:

• Patients who are participating in another clinical trial of a drug product or medical device;
• Patients previously enrolled in this trial;
• Women of childbearing age with a non-negative pregnancy test prior to surgical procedure, or lactating women;
• Patients treated with major surgeries (e.g., open-heart surgery, cranial surgery) within 30 days prior to enrollment in the study;
• 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);
• Calcified lesions that are not expected to be dilated with a balloon;
• AVF/AVG implanted with a stent;
• AVF/AVG lesions previously treated with DCB;
• Target lesions located at the venous anastomosis of AVF/AVG;
• Impaired central venous reflux ;
• Presence of a stenotic lesion in the artery that severely interferes with blood flow;
• Patients with known allergy or intolerance to paclitaxel or contrast agent;
• Patients with a life expectancy of less than 1 year;
• Patients with concomitant systemic lupus erythematosus (SLE), ANCA-associated small vessel vasculitis;
• Patients with a history of coagulopathy or thrombocytopenic purpura;

Sponsors & Collaborators

• DK Medical Technology (Suzhou) Co., Ltd.: lead

Study Sites (10)

Emergency general hospital

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Tongren hospital, Capital medical university

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese

Shanghai, Shanghai Municipality, 200000, China

Location

Huashan hospital affiliated to FuDan university

Shanghai, Shanghai Municipality, China

Location

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Location

Taiyuan Central Hospital

Taiyuan, Shanxi, China

Location

Shaoyifu hospital, zhejiang medical universiyt

Hangzhou, Zhejiang, China

Location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location

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

• YE CHAOYANG

  ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 13, 2020
• Study Start: July 23, 2019
• Primary Completion: October 2, 2021
• Study Completion: January 4, 2022
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)