Back to resultsStudy Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula
Primary Purpose
Arteriovenous Fistula
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Arteriovenous Fistula
Eligibility Criteria
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.
Sites / Locations
- Peking University First Hospital
- Beijing Tongren Hospital
- The First Affiliated Hospital of Jinan University
- The First Affiliated Hospital of Zhengzhou University
- The Second Affiliated Hospital of Nanjing Medical University
- Longhua Hospital Shanghai University of Traditional Chinese Medicine
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental: Tri-wire Peripheral Balloon Dilatation Catheter
Active Comparator: OHICHO Ⅱ PTA Balloon Catheter.
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Technical Success
The target lesion residual stenosis<30%
Secondary Outcome Measures
Device Success
During the operation, Balloon dilatation catheters can be delivered to the target lesion, inflated≤RBP without rupture and withdrawed successfully
Procedural Success
Base on the technical success, without MAE including death, thrombosis, allergic reactions, pulmonary diseases (pulmonary edema)
Dilating Pressure
The minimum pressure with which the balloon can be completely inflated without waist during the operation
Pain Score
The pain during dilating procedure, measured by NRS (increase from 0 to 10)
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.
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
Fistula Blood Flow
Measured Brachial artery blood flow of arteriovenous fistula flow assessed by DUS.
Adverse Events
Number of device and procedure related adverse events (CEC Adjudicated)
Full Information
NCT ID
NCT04393688
First Posted
May 14, 2020
Last Updated
May 18, 2020
Sponsor
BrosMed Medical Co., Ltd
Collaborators
CCRF Inc., Beijing, China
1. Study Identification
Unique Protocol Identification Number
NCT04393688
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2020 (Anticipated)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BrosMed Medical Co., Ltd
Collaborators
CCRF Inc., Beijing, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Tri-wire Peripheral Balloon Dilatation Catheter
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Comparator: OHICHO Ⅱ PTA Balloon Catheter.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter
Other Intervention Name(s)
Device: OHICHO Ⅱ PTA Balloon Catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Technical Success
Description
The target lesion residual stenosis<30%
Time Frame
Right after operation
Secondary Outcome Measure Information:
Title
Device Success
Description
During the operation, Balloon dilatation catheters can be delivered to the target lesion, inflated≤RBP without rupture and withdrawed successfully
Time Frame
Right after operation
Title
Procedural Success
Description
Base on the technical success, without MAE including death, thrombosis, allergic reactions, pulmonary diseases (pulmonary edema)
Time Frame
12-48 hours
Title
Dilating Pressure
Description
The minimum pressure with which the balloon can be completely inflated without waist during the operation
Time Frame
During the operation
Title
Pain Score
Description
The pain during dilating procedure, measured by NRS (increase from 0 to 10)
Time Frame
Right after operation
Title
Target Lesion Primary Patency (TLPP)
Description
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.
Time Frame
1 month
Title
Target lesion restenosis
Description
Target lesion diameter restenosis rate（measured by DUS）=100%*(1-(MLD/RVD)) (MLD includes 5mm range of proximal and distal of targer lesions
Time Frame
1 month
Title
Fistula Blood Flow
Description
Measured Brachial artery blood flow of arteriovenous fistula flow assessed by DUS.
Time Frame
1 month
Title
Adverse Events
Description
Number of device and procedure related adverse events (CEC Adjudicated)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qizhuang Jin
Phone
13301011122
Email
jinqizhuang@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yanqi Yin
Phone
13810454638
Email
thomasyq135@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qizhuang Jin
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qizhuang Jin
Phone
13301011122
Email
jinqizhuang@bjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yanqi Yin
Phone
13810454638
Email
thomasyq135@163.com
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengya Yu
Phone
13910011332
Email
zhengyayu_tr@126.com
First Name & Middle Initial & Last Name & Degree
Xin Chen
Phone
18101031315
Email
william19830315@sohu.com
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Hu
Phone
13760885770
Email
hubo26@foxmail.com
First Name & Middle Initial & Last Name & Degree
Zongchao Yu
Phone
13247362204
Email
709401195@qq.com
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei Wang
Phone
13523467291
Email
wangpei146@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xianhui Liang
Phone
13949002155
Email
liangxianhui1776@126.com
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junwei Yang
Phone
18951767513
Email
jwyang@njmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Hong Ye
Phone
13082552804
Email
yehong@njmu.edu.cn
Facility Name
Longhua Hospital Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaxue Shi
Phone
13918331840
Email
drshiyaxue@163.com
First Name & Middle Initial & Last Name & Degree
Xuedong Bao
Phone
18717797712
Email
baoxuedong6413@sina.com
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhengjiang
ZIP/Postal Code
310016
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Li
Phone
13588706757
Email
lihua@srrsh.com
First Name & Middle Initial & Last Name & Degree
Xuan Zheng
Phone
13675891157
Email
349454663@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula
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