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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
328
Subjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon
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.
Time frame: 6 months post-procedure
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.
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
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.
Time frame: 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.
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The Second Hospital of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGBeijing Haidian Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGGuangzhou First People's Hospital
Guanzhou, Guangdong, China
NOT_YET_RECRUITINGHuizhou Central People's Hospital
Huizhou, Guangdong, China
NOT_YET_RECRUITINGPeking University Shenzhen Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGThe Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGLiuzhou Traditional Chinese Medical Hospital
Liuchow, Guangxi, China
NOT_YET_RECRUITINGForesea Life Insurance Guangxi Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGThe Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
NOT_YET_RECRUITING...and 23 more locations
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
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.
Time frame: 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.
Time frame: 0-5 days post-procedure
Clinical Success
Defined as ability to complete at least one successful hemodialysis session post-procedure.
Time frame: 0-5 days post-procedure