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

Not Applicable

• Conditions: Arteriovenous Fistula

• Registration Number: NCT04393688
• Lead Sponsor: BrosMed Medical Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-18
• Last Update Submitted: 2020-05-18
• Study First Posted: 2020-05-19
• Last Update Posted: 2020-05-20
• Study Start: 2020-05-25
• Primary Completion: 2020-07-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

1. Age≥18 years;
2. Able to understand the purpose of the study, willing to participate and sign the informed consent, able and willing to accept the follow-up;
3. 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.
4. Reference vessel diameter of target lesion from 3.0 mm to 8.0 mm.
5. Target lesion located from proximal to the anastomosis to the reflux vein at the distal end of the subclavian vein.
6. De novo or restenosis lesion.
7. Single or tandem lesion, length of which ≤ 60mm.

Exclusion Criteria

1. Women who are pregnant, nursing, or planning to become pregnant during the study.
2. Patients who have accepted major surgeries within 30 days prior to the enrollment. (such as thoracic surgery, cranial surgery).
3. Patients who plan to accept major surgeries within 30 days after the enrollment. (such as thoracic surgery, cranial surgery).
4. Occlusion lesion or thrombosis.
5. Infected fistula or severe systemic infection.
6. Patients who suffer from central venous diseases.
7. Patients known to be allergic or contraindicated to contrast agents.
8. Patients who have participated in another clinical trial within 3 months prior to the study, or previous enrollment in this study.
9. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Technical Success	Right after operation	The target lesion residual stenosis\<30%

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhengjiang, China

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Jinan University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

Longhua Hospital Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China