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

Fistulas Arteriovenous Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04226599
• Other study ID #: VP-P-2018-018
• Status: Completed
• Phase: N/A
• Start date: July 23, 2019
• Est. completion date: January 4, 2022

Study information

• Verified date: February 2024
• Source: DK Medical Technology (Suzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 4, 2022
• Est. primary completion date: October 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Fistulas Arteriovenous

Intervention

Device:
• Dissolve AVF
Subjects in the test group will be treated with peripheral scoring drug balloon.
• Armada 35
Subjects in the test group will be treated with plain balloon catheter.

Locations

Country	Name	City	State
China	Emergency general hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Tongren hospital, Capital medical university	Beijing	Beijing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Shaoyifu hospital, zhejiang medical universiyt	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Huashan hospital affiliated to FuDan university	Shanghai	Shanghai
China	Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese	Shanghai	Shanghai
China	Taiyuan Central Hospital	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
DK Medical Technology (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 month
Secondary	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.	12 Month
Secondary	Device success	Successful delivery to the target lesion, deployment, and retrieval at index procedure	during the procedure
Secondary	Clinical success	The resumption of dialysis for at least one session after the index procedure	5 days
Secondary	Procedural Success	residual stenosis=30% and absence of SAE during perioperative perio	2 weeks