Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis

Arteriovenous Fistula Stenosis Clinical Trial

— SCDB  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422845
• Other study ID #: VP-P-24-012
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: July 2027

Study information

• Verified date: May 2024
• Source: DK Medical Technology (Suzhou) Co., Ltd.
• Contact: Yuzhu Wang, MD
• Phone: 18701387950
• Email: wyz4417[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 328
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age = 18 and = 80 years old;

2. The patient's AVF/AVG is mature and has successfully completed hemodialysis at least once;

3. The target lesion is located at the AVF/AVG return vein and venous side anastomosis;

4. 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.;

5. 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);

6. 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;

7. The patient voluntarily signs the informed consent form.

Exclusion Criteria:

1. Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding;

2. Patients who have undergone major surgical treatment within 30 days before inclusion in the study;

3. Calcified lesions that are not expected to be expandable with balloons;

4. Patients with thrombosis at the access stenosis site;

5. The target lesion is located at the blood supply artery and arterial anastomosis;

6. Patients known to be allergic to or intolerant to contrast media and paclitaxel;

7. The patient's life expectancy is less than 2 years;

8. Patients with systemic lupus erythematosus and antineutrophil cytoplasmic antibody (ANCA)-associated small vessel vasculitis;

9. Patients with kidney transplantation or those who planned to undergo kidney transplantation or switch to peritoneal dialysis;

10. Vascular access infection or systemic active infection;

11. Those who have participated in unfinished clinical trials of other drugs or devices;

12. Patients with other medical conditions that the investigator believes are not suitable to participate in this study.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula Stenosis
• Constriction, Pathologic
• Fistula

Intervention

Device:
• Dissolve AV Peripheral Scoring Drug-coated Balloon
Subjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon

Locations

Country	Name	City	State
China	Beijing Haidian Hospital	Beijing	Beijing
China	The Affiliated Hospital To Changchun University of Chinese Medicine	Changchun	Jilin
China	Changsha Jieao Kidney Disease Hospital	Changsha	Hunan
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Qilu Hospital of Shandong University Dezhou Hospital	Dezhou	Shandong
China	Guangzhou First People's Hospital	Guanzhou	Guangdong
China	The Affiliated Cancer Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Sir Run Run Shaw Hospital Zhejiang University School of medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Huizhou Central People's Hospital	Huizhou	Guangdong
China	Central Hospital Affiliated To Shandong First Medical University	Jinan	Shandong
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong
China	Jinhua Hospital of TCM	Jinhua	Zhejiang
China	Liuzhou Traditional Chinese Medical Hospital	Liuzhou	Guangxi
China	Mianyang Central Hospital	Mianyang	Sichuan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan
China	Foresea Life Insurance Guangxi Hospital	Nanning	Guangxi
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	People's Hospital of Rizhao	Rizhao	Shandong
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	The Eighth Affiliated Hospital, Sun Yat-sen University	Shenzhen	Guangdong
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Ürümqi
China	Tongji Hospital Affiliated To Tongji Medical College HUST	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Henan Provincial People's Hospital	Zhengzhou	Henan

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	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.	6 months post-procedure
Secondary	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.	12, 24 months post-procedure
Secondary	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.	6, 12, 24 months post-procedure
Secondary	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.	1, 6, 12, 18, and 24 months post-procedure
Secondary	Clinically-driven Target Shunt Revascularization (CD-TSR)		1, 6, 12, 18, and 24 months post-procedure
Secondary	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.	During the procedure
Secondary	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.	0-5 days post-procedure
Secondary	Clinical Success	Defined as ability to complete at least one successful hemodialysis session post-procedure.	0-5 days post-procedure