Clinical trial NCT04393688: Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arteriovenous Fistula
Lead sponsor: BrosMed Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: CCRF Inc., Beijing, China
First posted: 2020-05-19
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Technical Success
timeFrame: Right after operation
Secondary outcomes:
measure: Device Success
timeFrame: Right after operation
measure: Procedural Success
timeFrame: 12-48 hours
measure: Dilating Pressure
timeFrame: During the operation
measure: Pain Score
timeFrame: Right after operation
measure: Target Lesion Primary Patency (TLPP)
timeFrame: 1 month
measure: Target lesion restenosis
timeFrame: 1 month
measure: Fistula Blood Flow
timeFrame: 1 month
measure: Adverse Events
timeFrame: 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhengjiang
Study officials:
affiliation: Peking University First Hospital
name: Qizhuang Jin
role: PRINCIPAL_INVESTIGATOR
References: