Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula

Study Overview
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Brief Summary
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This prospective, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Tri-wire Peripheral Balloon Dilatation Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Official Title
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A Prospective, Multicenter, Randomized, Controlled Study to Evaluate the Safety and Efficacy of a Tri-wire Balloon Dilatation Catheter for the Treatment of Dysfunctional AV Fistula

Conditions
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Arteriovenous Fistula

Intervention / Treatment
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* Combination Product: Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years; Able to understand the purpose of the study, willing to participate and sign the informed consent, able and willing to accept the follow-up; Indications of percutaneous transluminal angioplasty for target lesion: target lesion shows >50% narrowing relative to adjacent normal vein diameter by angiography or ultrasound with one of the indicators listed in KDOQI vascular access guideline 2019 update Table 13.2. Reference vessel diameter of target lesion from 3.0 mm to 8.0 mm. Target lesion located from proximal to the anastomosis to the reflux vein at the distal end of the subclavian vein. De novo or restenosis lesion. Single or tandem lesion, length of which ≤ 60mm. Exclusion Criteria: Women who are pregnant, nursing, or planning to become pregnant during the study. Patients who have accepted major surgeries within 30 days prior to the enrollment. (such as thoracic surgery, cranial surgery). Patients who plan to accept major surgeries within 30 days after the enrollment. (such as thoracic surgery, cranial surgery). Occlusion lesion or thrombosis. Infected fistula or severe systemic infection. Patients who suffer from central venous diseases. Patients known to be allergic or contraindicated to contrast agents. Patients who have participated in another clinical trial within 3 months prior to the study, or previous enrollment in this study. Subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol or confound the data interpretation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Tri-wire Peripheral Balloon Dilatation Catheter<br>Percutaneous transluminal angiography (PTA) will be performed using the Tri-wire Peripheral Balloon Dilatation Catheter. Interventions: Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter; Procedure: Percutaneous Transluminal Angiography. | Combination Product: Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter<br>* Procedure: Percutaneous Transluminal Angiography, Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.<br>* Other names: Device: OHICHO Ⅱ PTA Balloon Catheter;|
| Active Comparator: Active Comparator: OHICHO Ⅱ PTA Balloon Catheter.<br>Percutaneous transluminal angiography (PTA) will be performed using OHICHO Ⅱ PTA Balloon Catheter, a commercially available high-pressure PTA balloon. Multiple balloons, inflations and/or prolonged inflation may be used. Interventions: Device: OHICHO Ⅱ PTA Balloon Catheter. Procedure: Percutaneous Transluminal Angiography. | Combination Product: Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter<br>* Procedure: Percutaneous Transluminal Angiography, Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.<br>* Other names: Device: OHICHO Ⅱ PTA Balloon Catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | The target lesion residual stenosis<30% | Right after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success | During the operation, Balloon dilatation catheters can be delivered to the target lesion, inflated≤RBP without rupture and withdrawed successfully | Right after operation | 
| Procedural Success | Base on the technical success, without MAE including death, thrombosis, allergic reactions, pulmonary diseases (pulmonary edema) | 12-48 hours | 
| Dilating Pressure | The minimum pressure with which the balloon can be completely inflated without waist during the operation | During the operation | 
| Pain Score | The pain during dilating procedure, measured by NRS (increase from 0 to 10) | Right after operation | 
| Target Lesion Primary Patency (TLPP) | Defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. TLPP ends with a clinically driven re-intervention of the target lesion or access thrombosis. | 1 month | 
| Target lesion restenosis | Target lesion diameter restenosis rate（measured by DUS）=100%*(1-(MLD/RVD)) (MLD includes 5mm range of proximal and distal of targer lesions | 1 month | 
| Fistula Blood Flow | Measured Brachial artery blood flow of arteriovenous fistula flow assessed by DUS. | 1 month | 
| Adverse Events | Number of device and procedure related adverse events (CEC Adjudicated) | 1 month |