Arteriovenous Fistula StenosisSCDBNCT06422845
Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
A study testing Dissolve AV Peripheral Scoring Drug-coated Balloon in people with Arteriovenous Fistula Stenosis, run by DK Medical Technology (Suzhou) Co., Ltd. at 33 sites in China.
Trial summary
This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous fistula stenosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arteriovenous Fistula Stenosis
- What is being tested?
- Dissolve AV Peripheral Scoring Drug-coated Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 33 sitesChina
- Study dates
- 30 Sep 2024to Jul 2027
- 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
- Age ≥ 18 and ≤ 80 years old;
- The patient's AVF/AVG is mature and has successfully completed hemodialysis at least once;
- The target lesion is located at the AVF/AVG return vein and venous side anastomosis;
- Hemodynamically significant AVF/AVG return vein stenosis ≥ 50% as assessed by ultrasound or contrast imaging, and any of the following clinical symptoms, signs or indicators are present, including significant increase in venous pressure during dialysis, abnormal physical examination, decreased pump-controlled blood flow, decreased adequacy of dialysis, brachial artery blood flow < 600 ml/min or decreased by 25% compared with the previous follow-up visit, etc.;
- The target lesion is a primary or restenotic lesion, consisting of one or more tandem lesions (if the total length of adjacent tandem lesions is ≤ 60 mm, it can be considered a single target lesion);
- Visual inspection of the reference blood vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is ≤ 60mm;
- The patient voluntarily signs the informed consent form.
Who cannot join
- Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding;
- Patients who have undergone major surgical treatment within 30 days before inclusion in the study;
- Calcified lesions that are not expected to be expandable with balloons;
- Patients with thrombosis at the access stenosis site;
- The target lesion is located at the blood supply artery and arterial anastomosis;
- Patients known to be allergic to or intolerant to contrast media and paclitaxel;
Show all 12Show fewer
- The patient's life expectancy is less than 2 years;
- Patients with systemic lupus erythematosus and antineutrophil cytoplasmic antibody (ANCA)-associated small vessel vasculitis;
- Patients with kidney transplantation or those who planned to undergo kidney transplantation or switch to peritoneal dialysis;
- Vascular access infection or systemic active infection;
- Those who have participated in unfinished clinical trials of other drugs or devices;
- Patients with other medical conditions that the investigator believes are not suitable to participate in this study.
Trial locations and contacts
33 sites in 1 country. Contact the study team or a site near you to ask about taking part.
33 sites in 1 country
China33 sites, 33 recruiting
- Recruiting
Beijing Haidian Hospital
Beijing, Beijing Municipality
Yuzhu Wang, MD, 18701387950, wyz4417@126.com
- Not yet recruiting
The Affiliated Hospital To Changchun University of Chinese Medicine
Changchun, Jilin
Mingxin Chang
- Not yet recruiting
Changsha Jieao Kidney Disease Hospital
Changsha, Hunan
Yong Xu
- Not yet recruiting
Hunan Provincial People's Hospital
Changsha, Hunan
Xun Luo
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Hong Wu
- Not yet recruiting
Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital
Chengdu, Sichuan
Qiang He
- Not yet recruiting
West China Hospital Sichuan University
Chengdu, Sichuan
Ping Fu
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Qining Fu
- Not yet recruiting
Qilu Hospital of Shandong University Dezhou Hospital
Dezhou, Shandong
Jing Sun
- Not yet recruiting
Guangzhou First People's Hospital
Guanzhou, Guangdong
Riguang Liu
- Not yet recruiting
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou
Zongyang Liu
- Not yet recruiting
Sir Run Run Shaw Hospital Zhejiang University School of medicine
Hangzhou, Zhejiang
Hua Li
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Hua Jiang
- Not yet recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui
Liang Yuan
- Not yet recruiting
Huizhou Central People's Hospital
Huizhou, Guangdong
Qiming Chen
- Not yet recruiting
Central Hospital Affiliated To Shandong First Medical University
Jinan, Shandong
Xiaoping Wang
- Not yet recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong
Zunsong Wang
- Not yet recruiting
Jinhua Hospital of TCM
Jinhua, Zhejiang
Yangbiao He
- Not yet recruiting
Liuzhou Traditional Chinese Medical Hospital
Liuzhou, Guangxi
Yuhong Chen
- Not yet recruiting
Mianyang Central Hospital
Mianyang, Sichuan
Dan Liao
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Yan Yan
- Not yet recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan
Heping Zhang
- Not yet recruiting
Foresea Life Insurance Guangxi Hospital
Nanning, Guangxi
Xiaomei Peng
- Not yet recruiting
Qingdao Municipal Hospital
Qingdao, Shandong
Jian Sun
- Not yet recruiting
People's Hospital of Rizhao
Rizhao, Shandong
Hong Zhang
- Not yet recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Wei Liang
- Not yet recruiting
The Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong
Tiecheng Yang
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
Hua Chen
- Not yet recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Liyun Xu
- Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Ürümqi
Alpati
- Not yet recruiting
Tongji Hospital Affiliated To Tongji Medical College HUST
Wuhan, Hubei
Fan He
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Shifeng Yang
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Hongtao Zhang
About this study
Official title: A Prospective, Multicenter, Single-Arm Target Value Clinical Study to Evaluate the Safety and Effectiveness of Peripheral Scoring Drug-coated Balloon Dilation Catheter in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous fistula stenosis.
Read the detailed description
This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters (SDCB) in the treatment of hemodialysis arteriovenous fistula stenosis. A total of 328 participants will be enrolled across multiple clinical trial sites. Participants will undergo a surgical procedure using a peripheral scoring drug-coated balloon dilation catheter, with follow-up within 5 days, at 1 month, and 6 months after the procedure, then at 12, 18, and 24 months post-procedure. The target lesion primary patency (TLPP) at 6 months post-procedure is the defined primary endpoint to evaluate the safety and effectiveness of the peripheral scoring drug balloon dilatation catheter.
- Conditions
- Arteriovenous Fistula Stenosis
- Being tested
- Dissolve AV Peripheral Scoring Drug-coated Balloon
- Keywords
- arteriovenous fistula stenosis, scoring, hemodialysis, drug-coated balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dissolve AV Peripheral Scoring Drug-coated BalloonDevice
Also called Scoring Drug-coated Balloon
Subjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon
| Study group | Role | What they receive |
|---|---|---|
| Dissolve AV Peripheral Scoring Drug-coated Balloon | Experimental | Subjects in this group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon dilatation catheter Receives: Device: Dissolve AV Peripheral Scoring Drug-coated Balloon |
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
Target Lesion Primary Patency is defined as freedom from clinically driven Target Lesion Failure (TLF) (including +/-5mm proximal or distal of the target lesion) or Vascular Access Thrombosis.
TLF is defined as the presence of at least one clinical symptom, sign or indicator (defined according to the NKF-K/DOQI guideline) due to target lesion stenosis (≥ 50% stenosis of the target lesion assessed by contrast angiography or ultrasound), including a significant increase in venous pressure during dialysis, high blood pressure, abnormal physical examination, decreased pump-controlled blood flow, decreased dialysis adequacy, brachial artery blood flow < 600 ml/min or decreased by 25% compared with the previous follow-up, etc.
Measured: 6 months post-procedure
Secondary outcomes (7)
Target Lesion Primary Patency (TLPP)
TLF is defined as the presence of at least one clinical symptom, sign or indicator (defined according to the NKF-K/DOQI guideline) due to target lesion stenosis (≥ 50% stenosis of the target lesion assessed by contrast angiography or ultrasound), including a significant increase in venous pressure during dialysis, high blood pressure, abnormal physical examination, decreased pump-controlled blood flow, decreased dialysis adequacy, brachial artery blood flow < 600 ml/min or decreased by 25% compared with the previous follow-up, etc.
Measured: 12, 24 months post-procedure
Proportion of patients whose peak systolic flow velocity ratio (PSVR) ≤ 2.0, as determined by Doppler ultrasound (DUS), so as to confirm the absence of restenosis
Proportion of patients whose peak systolic flow velocity ratio (PSVR) ≤ 2.0, as determined by Doppler ultrasound (DUS), at 6, 12, and 24 months post-procedure, so as to confirm the absence of restenosis.
Measured: 6, 12, 24 months post-procedure
Clinically-driven Target Lesion Revascularization (CD-TLR)
Any reintervention of a target lesion (including +/-5 mm proximal or distal to the target lesion) as determined by clinical symptoms or dialysis indicators indicating that it is unable to perform dialysis.
Measured: 1, 6, 12, 18, and 24 months post-procedure
Clinically-driven Target Shunt Revascularization (CD-TSR)
Measured: 1, 6, 12, 18, and 24 months post-procedure
Device Success
Defined as the ability of the balloon to reach the target lesion, be successfully expanded without rupture, and be successfully withdrawn. Evaluation is based on single balloon dilation catheter.
Measured: During the procedure
Technical Success
Defined as residual stenosis of the target lesion post-procedure is ≤ 30%, and no serious adverse events related to the trial device occurred during the perioperative period.
Measured: 0-5 days post-procedure
Clinical Success
Defined as ability to complete at least one successful hemodialysis session post-procedure.
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 posted21 May 2024
- Study start30 Sep 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Fistula 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuzhu Wang, MD, Principal investigator, Beijing Haidian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422845
- Sponsor's protocol ID
- VP-P-24-012
- Acronym
- SCDB
- Status last verified
- Jan 2025
- First submitted
- 15 May 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Prospective, Multicenter, Single-Arm Target Value Clinical Study to Evaluate the Safety and Effectiveness of Peripheral Scoring Drug-coated Balloon Dilation Catheter in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
- ClinicalTrials.gov ID
- NCT06422845
- Acronym / sponsor ID
- SCDB / VP-P-24-012
- Conditions
- Arteriovenous Fistula Stenosis
- Keywords
- arteriovenous fistula stenosis, scoring, hemodialysis, drug-coated balloon
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- DK Medical Technology (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 21 May 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 prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous fistula stenosis.
Detailed description
This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters (SDCB) in the treatment of hemodialysis arteriovenous fistula stenosis. A total of 328 participants will be enrolled across multiple clinical trial sites. Participants will undergo a surgical procedure using a peripheral scoring drug-coated balloon dilation catheter, with follow-up within 5 days, at 1 month, and 6 months after the procedure, then at 12, 18, and 24 months post-procedure. The target lesion primary patency (TLPP) at 6 months post-procedure is the defined primary endpoint to evaluate the safety and effectiveness of the peripheral scoring drug balloon dilatation catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dissolve AV Peripheral Scoring Drug-coated Balloon | Experimental | Device: Dissolve AV Peripheral Scoring Drug-coated BalloonSubjects in this group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon dilatation catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 and ≤ 80 years old;
- The patient's AVF/AVG is mature and has successfully completed hemodialysis at least once;
- The target lesion is located at the AVF/AVG return vein and venous side anastomosis;
- Hemodynamically significant AVF/AVG return vein stenosis ≥ 50% as assessed by ultrasound or contrast imaging, and any of the following clinical symptoms, signs or indicators are present, including significant increase in venous pressure during dialysis, abnormal physical examination, decreased pump-controlled blood flow, decreased adequacy of dialysis, brachial artery blood flow < 600 ml/min or decreased by 25% compared with the previous follow-up visit, etc.;
- The target lesion is a primary or restenotic lesion, consisting of one or more tandem lesions (if the total length of adjacent tandem lesions is ≤ 60 mm, it can be considered a single target lesion);
Key exclusion criteria (12 listed)
- Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding;
- Patients who have undergone major surgical treatment within 30 days before inclusion in the study;
- Calcified lesions that are not expected to be expandable with balloons;
- Patients with thrombosis at the access stenosis site;
- The target lesion is located at the blood supply artery and arterial anastomosis;
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 |
|---|---|---|
| Dissolve AV Peripheral Scoring Drug-coated BalloonAlso: Scoring Drug-coated BalloonSubjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon | Device | Dissolve AV Peripheral Scoring Drug-coated Balloon |
Primary outcome
Target Lesion Primary Patency (TLPP) at 6 months post-procedure
Time frame: 6 months post-procedure
Target Lesion Primary Patency is defined as freedom from clinically driven Target Lesion Failure (TLF) (including +/-5mm proximal or distal of the target lesion) or Vascular Access Thrombosis. TLF is defined as the presence of at least one clinical symptom, sign or indicator (defined according to the NKF-K/DOQI guideline) due to target lesion stenosis (≥ 50% stenosis of the target lesion assessed by contrast angiography or ultrasound), including a significant increase in venous pressure during dialysis, high blood pressure, abnormal physical examination, decreased pump-controlled blood flow, decreased dialysis adequacy, brachial artery blood flow < 600 ml/min or decreased by 25% compared with the previous follow-up, etc.
7 secondary outcomes
Target Lesion Primary Patency (TLPP)
Time frame: 12, 24 months post-procedure
Proportion of patients whose peak systolic flow velocity ratio (PSVR) ≤ 2.0, as determined by Doppler ultrasound (DUS), so as to confirm the absence of restenosis
Time frame: 6, 12, 24 months post-procedure
Clinically-driven Target Lesion Revascularization (CD-TLR)
Time frame: 1, 6, 12, 18, and 24 months post-procedure
Clinically-driven Target Shunt Revascularization (CD-TSR)
Time frame: 1, 6, 12, 18, and 24 months post-procedure
Device Success
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.
- Individual participant dataSharing planned: No
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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.
Yuzhu Wang, MD principal investigator
Beijing Haidian Hospital
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dissolve AV Peripheral Scoring Drug-coated Balloon in people with Arteriovenous Fistula Stenosis, run by DK Medical Technology (Suzhou) Co., Ltd. at 33 sites in China.
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 7 inclusion and 12 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 33 sites in China. 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 Yuzhu Wang, MD (18701387950, wyz4417@126.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 post-procedure). 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.