Arteriovenous Fistula Stenosis
Conditions
Keywords
arteriovenous fistula stenosis, scoring, hemodialysis, drug-coated balloon
Brief 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.
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.
Interventions
DEVICEDissolve AV Peripheral Scoring Drug-coated Balloon
Subjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon
Sponsors
DK Medical Technology (Suzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Primary Patency (TLPP) at 6 months post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6, 12, 24 months post-procedure | 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. |
| Clinically-driven Target Lesion Revascularization (CD-TLR) | 1, 6, 12, 18, and 24 months post-procedure | 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. |
| Clinically-driven Target Shunt Revascularization (CD-TSR) | 1, 6, 12, 18, and 24 months post-procedure | — |
| Target Lesion Primary Patency (TLPP) | 12, 24 months post-procedure | 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. |
| Technical Success | 0-5 days post-procedure | 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. |
| Clinical Success | 0-5 days post-procedure | Defined as ability to complete at least one successful hemodialysis session post-procedure. |
| Device Success | During the procedure | 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. |
Countries
China
Contacts
Primary ContactYuzhu Wang, MD
Outcome results
None listed