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

Primary Purpose

Fistulas Arteriovenous

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dissolve AVF
Armada 35
Sponsored by
DK Medical Technology (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fistulas Arteriovenous focused on measuring Dialysis scoring Fistulas

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years and ≤ 75 years, male or female.
  • Arteriovenous fistula or Arteriovenous graft is matured and has undergone one or more hemodialysis sessions
  • Venous stenosis of the AV fistula or AV graft
  • target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1.Venous pressure increased significantly during dialysis,2.Abnomal phenomenon physical examination,3.Decrease in pumping blood flow.
  • Target lesion consists of a single lesion or a multiple lesions with target lesion length ≤ 40 mm. Reference vessel diameter of target lesion ≥ 4.0 mm and ≤ 7.0 mm.
  • If patient has non-target lesion, the stenosis ≥50% and don't need to be treated.
  • Patient able to give informed consent

Exclusion Criteria:

  • Women who are breastfeeding, pregnant or are intending to become pregnant
  • AVF located at lower limbs
  • two or more than two stenosis at the target vessel.
  • Obstruction of central venous return
  • ISR
  • AVF with acute thrombosis requiring lysis or thrombectomy in 30 days
  • vascular access has surgery in 30 days or intending to undergo a surgery
  • known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
  • Patients undergoing immunotherapy or suspected / confirmed vasculitis
  • Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura
  • Vascular access infection or systemic active infection
  • patients's life expectancy is less than 12 months
  • Renal transplantation has been planned or converted to peritoneal dialysis
  • Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program
  • involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test

Sites / Locations

  • Emergency general hospital
  • Peking Union Medical College Hospital
  • Tongren hospital, Capital medical university
  • The First Affiliated Hospital of Chongqing Medical University
  • ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese
  • Huashan hospital affiliated to FuDan university
  • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
  • Taiyuan Central Hospital
  • Shaoyifu hospital, zhejiang medical universiyt
  • The First Affiliated Hospital of Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dissolve AVF Group

PTA Group

Arm Description

This group treated with Peripheral scoring drug balloon.Dissolve AVF

This group treated with plain balloon catheter.Armada 35

Outcomes

Primary Outcome Measures

Primary patency rate of the target lesion at 6 month post procedure [ Target Lesion Primary Patency ]
Target Lesion Primary Patency is defined as Target Lesion((+/-5mm proximal or distal of the target lesion)) failure(TLF) or target Vasculal Access Thrombosis. TLF is defined as target lesion stenosis(Stenosis rate>30% by Digital Substraction Angiography(DSA)) result in insufficient hemodialysis flow (Refer to NKF-K/DOQIguideline) including: Venous pressure increased significantly during dialysis /Abnomal phenomenon physical examination/Decrease in pumping blood flow.

Secondary Outcome Measures

Primary patency of target lesion in 12 months
Target Lesion Primary Patency is defined as Target Lesion((+/-5mm proximal or distal of the target lesion)) failure(TLF) or target Vasculal Access Thrombosis. TLF is defined as target lesion stenosis(Stenosis rate >30% by Digital Substraction Angiography(DSA)) result in insufficient hemodialysis flow (Refer to NKF-K/DOQIguideline)including: Venous pressure increased significantly during dialysis /Abnomal phenomenon physical examination/Decrease in pumping blood flow.
Device success
Successful delivery to the target lesion, deployment, and retrieval at index procedure
Clinical success
The resumption of dialysis for at least one session after the index procedure
Procedural Success
residual stenosis≤30% and absence of SAE during perioperative perio

Full Information

First Posted
January 7, 2020
Last Updated
February 9, 2022
Sponsor
DK Medical Technology (Suzhou) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04226599
Brief Title
A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV
Acronym
DissolveAVF
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 23, 2019 (Actual)
Primary Completion Date
October 2, 2021 (Actual)
Study Completion Date
August 21, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DK Medical Technology (Suzhou) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a prospective, multi-center, randomized controlled, open-label, superiority study. A total of 220 subjects will be enrolled from 10 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fistulas Arteriovenous
Keywords
Dialysis scoring Fistulas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dissolve AVF Group
Arm Type
Experimental
Arm Description
This group treated with Peripheral scoring drug balloon.Dissolve AVF
Arm Title
PTA Group
Arm Type
Active Comparator
Arm Description
This group treated with plain balloon catheter.Armada 35
Intervention Type
Device
Intervention Name(s)
Dissolve AVF
Other Intervention Name(s)
Using Peripheral scoring drug balloon catheter to cover the whole treated segment
Intervention Description
Subjects in the test group will be treated with peripheral scoring drug balloon.
Intervention Type
Device
Intervention Name(s)
Armada 35
Other Intervention Name(s)
Using plain balloon catheter to cover the whole treated segment
Intervention Description
Subjects in the test group will be treated with plain balloon catheter.
Primary Outcome Measure Information:
Title
Primary patency rate of the target lesion at 6 month post procedure [ Target Lesion Primary Patency ]
Description
Target Lesion Primary Patency is defined as Target Lesion((+/-5mm proximal or distal of the target lesion)) failure(TLF) or target Vasculal Access Thrombosis. TLF is defined as target lesion stenosis(Stenosis rate>30% by Digital Substraction Angiography(DSA)) result in insufficient hemodialysis flow (Refer to NKF-K/DOQIguideline) including: Venous pressure increased significantly during dialysis /Abnomal phenomenon physical examination/Decrease in pumping blood flow.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Primary patency of target lesion in 12 months
Description
Target Lesion Primary Patency is defined as Target Lesion((+/-5mm proximal or distal of the target lesion)) failure(TLF) or target Vasculal Access Thrombosis. TLF is defined as target lesion stenosis(Stenosis rate >30% by Digital Substraction Angiography(DSA)) result in insufficient hemodialysis flow (Refer to NKF-K/DOQIguideline)including: Venous pressure increased significantly during dialysis /Abnomal phenomenon physical examination/Decrease in pumping blood flow.
Time Frame
12 Month
Title
Device success
Description
Successful delivery to the target lesion, deployment, and retrieval at index procedure
Time Frame
during the procedure
Title
Clinical success
Description
The resumption of dialysis for at least one session after the index procedure
Time Frame
5 days
Title
Procedural Success
Description
residual stenosis≤30% and absence of SAE during perioperative perio
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years and ≤ 75 years, male or female. Arteriovenous fistula or Arteriovenous graft is matured and has undergone one or more hemodialysis sessions Venous stenosis of the AV fistula or AV graft target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1.Venous pressure increased significantly during dialysis,2.Abnomal phenomenon physical examination,3.Decrease in pumping blood flow. Target lesion consists of a single lesion or a multiple lesions with target lesion length ≤ 40 mm. Reference vessel diameter of target lesion ≥ 4.0 mm and ≤ 7.0 mm. If patient has non-target lesion, the stenosis ≥50% and don't need to be treated. Patient able to give informed consent Exclusion Criteria: Women who are breastfeeding, pregnant or are intending to become pregnant AVF located at lower limbs two or more than two stenosis at the target vessel. Obstruction of central venous return ISR AVF with acute thrombosis requiring lysis or thrombectomy in 30 days vascular access has surgery in 30 days or intending to undergo a surgery known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc. Patients undergoing immunotherapy or suspected / confirmed vasculitis Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura Vascular access infection or systemic active infection patients's life expectancy is less than 12 months Renal transplantation has been planned or converted to peritoneal dialysis Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YE CHAOYANG
Organizational Affiliation
ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese
Official's Role
Study Chair
Facility Information:
Facility Name
Emergency general hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Tongren hospital, Capital medical university
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Huashan hospital affiliated to FuDan university
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Taiyuan Central Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Shaoyifu hospital, zhejiang medical universiyt
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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