Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula
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
1 other identifier
interventional
168
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2020
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2020
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedStudy Start
First participant enrolled
May 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedMay 20, 2020
May 1, 2020
1 month
May 14, 2020
May 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Technical Success
The target lesion residual stenosis\<30%
Right after operation
Secondary Outcomes (8)
Device Success
Right after operation
Procedural Success
12-48 hours
Dilating Pressure
During the operation
Pain Score
Right after operation
Target Lesion Primary Patency (TLPP)
1 month
- +3 more secondary outcomes
Study Arms (2)
Experimental: Tri-wire Peripheral Balloon Dilatation Catheter
EXPERIMENTALPercutaneous 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.
Active Comparator: OHICHO Ⅱ PTA Balloon Catheter.
ACTIVE COMPARATORPercutaneous 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BrosMed Medical Co., Ltdlead
- CCRF Inc., Beijing, Chinacollaborator
Study Sites (7)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhengjiang, 310016, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qizhuang Jin
Peking University First Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2020
First Posted
May 19, 2020
Study Start
May 25, 2020
Primary Completion
July 1, 2020
Study Completion
May 1, 2021
Last Updated
May 20, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share