Arteriovenous Graft StenosisDKTAVGNCT06503692
Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
A study testing DKutting PTA Scoring Balloon Dilatation Catheter and Peripheral Balloon Catheter in people with Arteriovenous Graft Stenosis, run by DK Medical Technology (Suzhou) Co., Ltd. at 7 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arteriovenous Graft Stenosis
- What is being tested?
- DKutting PTA Scoring Balloon Dilatation Catheter and Peripheral Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 13 Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Patients who have undergone major surgical treatment within 30 days before inclusion in the study;
- 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.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
China6 sites, 6 recruiting
- Not yet recruiting
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality
Zhengya Yu, MD
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Zhiming Ye, MD
- Not yet recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Hong Ye, MD
- Recruiting
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
Yaxue Shi, MD
- Not yet recruiting
South China Hospital of Shenzhen University
Shenzhen, Guangdong
Yangdong Liu, MD
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Pei Wang, MD, +86 13523467291, wangpei146@hotmail.com
Singapore1 site, 1 recruiting
- Not yet recruiting
National University Hospital of Singapore
Singapore
Jackie Ho Pei, MD
About this study
Official title: A Multicentre, Randomized Controlled Clinical Trial of Scoring Balloon Versus High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
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
- Being tested
- DKutting PTA Scoring Balloon Dilatation Catheter, Peripheral Balloon Catheter
- Keywords
- Arteriovenous Graft Stenosis, Scoring Balloon, Angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKutting PTA Scoring Balloon Dilatation CatheterDevice
Also called Scoring Balloon
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.
Peripheral Balloon CatheterDevice
The device is an over-the-wire (OTW) double-lumen balloon catheter. The balloon is inflated to a known diameter at a specified pressure.
| Study group | Role | What they receive |
|---|---|---|
| DKutting PTA Scoring Balloon Dilatation Catheter | Experimental | Subjects in this group are treated with DKutting PTA Scoring Balloon Dilatation Catheter Receives: Device: DKutting PTA Scoring Balloon Dilatation Catheter |
| Peripheral Balloon Catheter | Active comparator | Subjects in this group are treated with Peripheral Balloon Catheter Receives: Device: Peripheral Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
Target Lesion Primary Patency (TLPP) at 12 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.
Measured: 12 months
Access Circuit Primary Patency (ACPP) at 6 and 12 months post-procedure
ACPP is terminated when stenosis or thrombus causing abnormal clinical indicators occurs in any part of the AVG after surgery (inflow artery, entire graft, and outflow vein, including central vein). (Definition according to NKF- K/DOQI guidelines), including physical examination abnormalities or dialysis abnormalities. 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.
Measured: 6, 12 months post-procedure
Access Circuit Secondary Patency (ACSP) 6 and 12 months after surgery
ACSP terminates when the AVG is abandoned due to various reasons after surgery, during which multiple interventions can be performed to maintain the patency of the entire pathway.
Measured: 6, 12 months post-procedure
Acute Lumen Gain
Immediately after dilation, DSA uses two different angles (≥45°) for angiography (a unified x-ray ruler will be provided as the reference object to reduce measurement errors) Calculation formula: minimum lumen diameter of the target lesion immediately after dilation - minimum lumen diameter of the target lesion before procedure.
Measured: During the procedure
Technical Success
Residual stenosis of the target lesion after surgery is ≤30%, and no serious adverse events related to the investigational device occurred during the perioperative period.
Measured: 0-5 days post-procedure
Clinical Success
Complete at least one successful hemodialysis session after surgery
Measured: 0-5 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start13 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Graft StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pei Wang, MD, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503692
- Sponsor's protocol ID
- TR-0171
- Acronym
- DKTAVG
- Status last verified
- Jan 2025
- First submitted
- 10 Jul 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized Controlled Clinical Trial of Scoring Balloon Versus High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
- ClinicalTrials.gov ID
- NCT06503692
- Acronym / sponsor ID
- DKTAVG / TR-0171
- Conditions
- Arteriovenous Graft Stenosis
- Keywords
- Arteriovenous Graft Stenosis, Scoring Balloon, Angioplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- DK Medical Technology (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DKutting PTA Scoring Balloon Dilatation Catheter | Experimental | Device: DKutting PTA Scoring Balloon Dilatation CatheterSubjects in this group are treated with DKutting PTA Scoring Balloon Dilatation Catheter |
| Peripheral Balloon Catheter | Active comparator | Device: Peripheral Balloon CatheterSubjects in this group are treated with Peripheral Balloon Catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 ;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DKutting PTA Scoring Balloon Dilatation CatheterAlso: Scoring BalloonThe 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. | Device | DKutting PTA Scoring Balloon Dilatation Catheter |
| Peripheral Balloon CatheterThe device is an over-the-wire (OTW) double-lumen balloon catheter. The balloon is inflated to a known diameter at a specified pressure. | Device | Peripheral Balloon Catheter |
Primary outcome
Target Lesion Primary Patency (TLPP) at 6 months post-procedure
Time frame: 6 months
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 secondary outcomes
Target Lesion Primary Patency (TLPP) at 12 months post-procedure
Time frame: 12 months
Access Circuit Primary Patency (ACPP) at 6 and 12 months post-procedure
Time frame: 6, 12 months post-procedure
Access Circuit Secondary Patency (ACSP) 6 and 12 months after surgery
Time frame: 6, 12 months post-procedure
Acute Lumen Gain
Time frame: During the procedure
Technical Success
Time frame: 0-5 days post-procedure
Clinical Success
Time frame: 0-5 days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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WRAP North America
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pei Wang, MD principal investigator
The First Affiliated Hospital of Zhengzhou University
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DKutting PTA Scoring Balloon Dilatation Catheter and Peripheral Balloon Catheter in people with Arteriovenous Graft Stenosis, run by DK Medical Technology (Suzhou) Co., Ltd. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei Wang, MD (+86 13523467291, wangpei146@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Primary Patency (TLPP) at 6 months post-procedure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.