- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04393688
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Qizhuang Jin
- Phone Number: 13301011122
- Email: jinqizhuang@bjmu.edu.cn
Study Contact Backup
- Name: Yanqi Yin
- Phone Number: 13810454638
- Email: thomasyq135@163.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100034
- Peking University First Hospital
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Contact:
- Qizhuang Jin
- Phone Number: 13301011122
- Email: jinqizhuang@bjmu.edu.cn
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Contact:
- Yanqi Yin
- Phone Number: 13810454638
- Email: thomasyq135@163.com
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Beijing, Beijing, China, 100730
- Beijing Tongren Hospital
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Contact:
- Zhengya Yu
- Phone Number: 13910011332
- Email: zhengyayu_tr@126.com
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Contact:
- Xin Chen
- Phone Number: 18101031315
- Email: william19830315@sohu.com
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Guangdong
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Guangzhou, Guangdong, China, 510630
- The First Affiliated Hospital of Jinan University
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Contact:
- Bo Hu
- Phone Number: 13760885770
- Email: hubo26@foxmail.com
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Contact:
- Zongchao Yu
- Phone Number: 13247362204
- Email: 709401195@qq.com
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Henan
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Zhengzhou, Henan, China, 450052
- The First Affiliated Hospital of Zhengzhou University
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Contact:
- Pei Wang
- Phone Number: 13523467291
- Email: wangpei146@hotmail.com
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Contact:
- Xianhui Liang
- Phone Number: 13949002155
- Email: liangxianhui1776@126.com
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Jiangsu
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Nanjing, Jiangsu, China, 210011
- The Second Affiliated Hospital of Nanjing Medical university
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Contact:
- Junwei Yang
- Phone Number: 18951767513
- Email: jwyang@njmu.edu.cn
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Contact:
- Hong Ye
- Phone Number: 13082552804
- Email: yehong@njmu.edu.cn
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Shanghai
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Shanghai, Shanghai, China, 200032
- Longhua Hospital Shanghai University of Traditional Chinese Medicine
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Contact:
- Yaxue Shi
- Phone Number: 13918331840
- Email: drshiyaxue@163.com
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Contact:
- Xuedong Bao
- Phone Number: 18717797712
- Email: baoxuedong6413@sina.com
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Zhengjiang
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Hangzhou, Zhengjiang, China, 310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Contact:
- Hua Li
- Phone Number: 13588706757
- Email: lihua@srrsh.com
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Contact:
- Xuan Zheng
- Phone Number: 13675891157
- Email: 349454663@qq.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental: Tri-wire Peripheral Balloon Dilatation Catheter
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.
|
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.
Other Names:
|
ACTIVE_COMPARATOR: Active Comparator: OHICHO Ⅱ PTA Balloon Catheter.
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical Success
Time Frame: Right after operation
|
The target lesion residual stenosis<30%
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Right after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device Success
Time Frame: Right after operation
|
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
Time Frame: 12-48 hours
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Base on the technical success, without MAE including death, thrombosis, allergic reactions, pulmonary diseases (pulmonary edema)
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12-48 hours
|
Dilating Pressure
Time Frame: During the operation
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The minimum pressure with which the balloon can be completely inflated without waist during the operation
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During the operation
|
Pain Score
Time Frame: Right after operation
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The pain during dilating procedure, measured by NRS (increase from 0 to 10)
|
Right after operation
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Target Lesion Primary Patency (TLPP)
Time Frame: 1 month
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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.
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1 month
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Target lesion restenosis
Time Frame: 1 month
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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
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Fistula Blood Flow
Time Frame: 1 month
|
Measured Brachial artery blood flow of arteriovenous fistula flow assessed by DUS.
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1 month
|
Adverse Events
Time Frame: 1 month
|
Number of device and procedure related adverse events (CEC Adjudicated)
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1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Qizhuang Jin, Peking University First Hospital
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BM-821
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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