Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis

NCT06503692 | Recruiting

• 1 other identifier: TR-0171
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 7

Brief Summary

This is a multicenter, prospective, randomized controlled clinical study. Patients with hemodialysis arteriovenous graft fistula stenosis will be recruited to explore whether the scoring balloon is superior to the high pressure balloon in treating such lesions, so as to provide a basis for optimizing the treatment of such lesions. This study will be conducted in seven (7) clinical trial institutions, with a total of 140 subjects included. After randomization, the subjects will use either the scoring balloon dilatation catheter, developed and produced by DK Medical Technology Co., Ltd., or the peripheral balloon dilatation catheter for surgical treatment. Clinical follow-up will be carried out within 5 days, 3 months, 6 months, and 12 months after the procedure.

Conditions

Arteriovenous Graft Stenosis

Keywords

Arteriovenous Graft Stenosis; Scoring Balloon; Angioplasty

Outcome Measures

Primary Outcomes (1)

• Target Lesion Primary Patency (TLPP) at 6 months post-procedure

  TLPP is terminated by postoperative target lesion failure (TLF) (including the 5 mm range before and after the target lesion) or target lesion-related vascular access thrombosis. TLF is defined as the presence of at least one clinical indicator (defined according to the NKF-K/DOQI guidelines) caused by target lesion stenosis ( ≥50% stenosis of the target lesion assessed by contrast angiography or ultrasound), including physical examination abnormalities or dialysis abnormalities. Target lesion-related vascular access thrombosis is limited to: after the thrombus is removed during AVG thrombus treatment and before balloon dilatation, it is confirmed by ultrasound/DSA that the original target lesion has a stenosis ≥ 50%, or when the balloon is expanded with low pressure (\<6 atm) during intraluminal treatment, obvious balloon residual waisting can be seen at the target lesion; simple mural thrombus at the puncture point or other parts of the graft needs to be ruled out.

  6 months

Secondary Outcomes (6)

• Target Lesion Primary Patency (TLPP) at 12 months post-procedure

  12 months

• Access Circuit Primary Patency (ACPP) at 6 and 12 months post-procedure

  6, 12 months post-procedure

• Access Circuit Secondary Patency (ACSP) 6 and 12 months after surgery

  6, 12 months post-procedure

• Acute Lumen Gain

  During the procedure

• Technical Success

  0-5 days post-procedure

Study Arms (2)

DKutting PTA Scoring Balloon Dilatation Catheter

EXPERIMENTAL

Subjects in this group are treated with DKutting PTA Scoring Balloon Dilatation Catheter

Device: DKutting PTA Scoring Balloon Dilatation Catheter

Peripheral Balloon Catheter

ACTIVE COMPARATOR

Subjects in this group are treated with Peripheral Balloon Catheter

Device: Peripheral Balloon Catheter

Interventions

DKutting PTA Scoring Balloon Dilatation Catheter DEVICE

The device consists of a balloon catheter with scoring elements (triangular cross-section) fixed to the surface of the balloon and distributed radially at every 120°. When the balloon is inflated, the expansion force is focused along the scoring elements, causing it to expand under lower balloon pressure.

Also known as: Scoring Balloon

DKutting PTA Scoring Balloon Dilatation Catheter

Peripheral Balloon Catheter DEVICE

The device is an over-the-wire (OTW) double-lumen balloon catheter. The balloon is inflated to a known diameter at a specified pressure.

Peripheral Balloon Catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemodialysis patients aged ≥18 and ≤80 years old, (Note: Hemodialysis patients in Singapore aged ≥ 21 and ≤80 years old);
• AVG is mature and has successfully completed at least one hemodialysis treatment;
• The target lesion is located in the AVG return vein and the venous side anastomosis;
• The degree of stenosis of the target lesion is ≥50% (DSA visual inspection), and one of the following clinical indicators exists at the same time: Physical examination abnormalities include: open collateral veins, ipsilateral limb edema, changes in pulse characteristics, abnormal tremors, abnormal murmurs, etc.; Dialysis abnormalities include: increased venous pressure, new puncture difficulties, aspiration of thrombi, inability to reach target dialysis blood flow, prolonged haemostasis time after needle removal for 3 consecutive times, unexplained decrease in dialysis dose Kt/V (\>0.2 units), decrease in brachial artery blood flow (brachial artery blood flow \<650ml/min or decreased by 20% compared with the previous follow-up visit), etc.
• The target lesion is primary or restenotic, consisting of one or more series of lesions, and the reference blood vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is ≤80mm ;
• The patient voluntarily signs the informed consent form.

You may not qualify if:

• The target lesion is located in the feeding artery, arterial anastomosis, artificial blood vessel puncture site, cephalic venous arch, thoracic outlet or central vein;
• A stent has been implanted in any part of the access or there is ipsilateral central vein stenosis or occlusion that affects the function of the access;
• Severely calcified lesions that are not expected to be dilatable with balloons;
• Acute thrombosis or chronic total occlusion of AVG occurred at the time of enrolment;
• The target lesion or any part of the vascular access has received PTA treatment within the last month;
• There are thicker branch veins in the vein opening of the end-to-side anastomosis;
• Patients known to be allergic to or intolerant to contrast media;
• Patients receiving glucocorticoids or immunosuppressants;
• The patient's life expectancy is less than 1 year;
• Patients planning kidney transplantation or switching to peritoneal dialysis;
• The degree of stenosis in the puncture point area is \>50%；
• Patients with infection or other medical conditions that make the investigator think they are not suitable to participate in this study;
• Those who have participated in clinical trials of other drugs or devices but have not completed them.

Sponsors & Collaborators

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

Study Sites (7)

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

South China Hospital of Shenzhen University

Shenzhen, Guangdong, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

NOT YET RECRUITING

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

NOT YET RECRUITING

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

National University Hospital of Singapore

Singapore, Singapore

NOT YET RECRUITING

Study Officials

• Pei Wang, MD

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei Wang, MD

CONTACT

+86 13523467291; wangpei146@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: August 13, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

CN (6); SG (1)