Arteriovenous FistulaNCT04393688
Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula
A study testing Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter in people with Arteriovenous Fistula, run by BrosMed Medical Co., Ltd at 7 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 7 sitesChina
- Study dates
- 25 May 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Qizhuang Jin, 13301011122, jinqizhuang@bjmu.edu.cn
Yanqi Yin, 13810454638, thomasyq135@163.com
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Zhengya Yu, 13910011332, zhengyayu_tr@126.com
Xin Chen, 18101031315, william19830315@sohu.com
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
Bo Hu, 13760885770, hubo26@foxmail.com
Zongchao Yu, 13247362204, 709401195@qq.com
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhengjiang, 310016
Hua Li, 13588706757, lihua@srrsh.com
Xuan Zheng, 13675891157, 349454663@qq.com
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Junwei Yang, 18951767513, jwyang@njmu.edu.cn
Hong Ye, 13082552804, yehong@njmu.edu.cn
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Yaxue Shi, 13918331840, drshiyaxue@163.com
Xuedong Bao, 18717797712, baoxuedong6413@sina.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Pei Wang, 13523467291, wangpei146@hotmail.com
Xianhui Liang, 13949002155, liangxianhui1776@126.com
About this study
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
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.
- Conditions
- Arteriovenous Fistula
- Being tested
- Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination Product: Tri-wire Peripheral Balloon Dilatation CatheterCombination product
Also called Device: OHICHO Ⅱ PTA Balloon Catheter
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Tri-wire Peripheral Balloon Dilatation Catheter | Experimental | 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. Receives: Combination Product: Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter |
| Active Comparator: OHICHO Ⅱ PTA Balloon Catheter. | Active comparator | 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. Receives: Combination Product: Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
The target lesion residual stenosis<30%
Measured: Right after operation
Secondary outcomes (8)
Device Success
During the operation, Balloon dilatation catheters can be delivered to the target lesion, inflated≤RBP without rupture and withdrawed successfully
Measured: Right after operation
Procedural Success
Base on the technical success, without MAE including death, thrombosis, allergic reactions, pulmonary diseases (pulmonary edema)
Measured: 12-48 hours
Dilating Pressure
The minimum pressure with which the balloon can be completely inflated without waist during the operation
Measured: During the operation
Pain Score
The pain during dilating procedure, measured by NRS (increase from 0 to 10)
Measured: Right after operation
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.
Measured: 1 month
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
Measured: 1 month
Fistula Blood Flow
Measured Brachial artery blood flow of arteriovenous fistula flow assessed by DUS.
Measured: 1 month
Adverse Events
Number of device and procedure related adverse events (CEC Adjudicated)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start25 May 2020 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrosMed Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CCRF Inc., Beijing, China
- Responsible party
- Sponsor
- Investigators
- Qizhuang Jin, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393688
- Sponsor's protocol ID
- BM-821
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04393688
- Acronym / sponsor ID
- BM-821
- Conditions
- Arteriovenous Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- BrosMed Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- CCRF Inc., Beijing, China
- Study start
- 25 May 2020 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Tri-wire Peripheral Balloon Dilatation Catheter | Experimental | Combination Product: Combination Product: Tri-wire Peripheral Balloon Dilatation CatheterPercutaneous 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 comparator | Combination Product: Combination Product: Tri-wire Peripheral Balloon Dilatation CatheterPercutaneous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination Product: Tri-wire Peripheral Balloon Dilatation CatheterAlso: Device: OHICHO Ⅱ PTA Balloon CatheterProcedure: 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. | Combination product | Active Comparator: OHICHO Ⅱ PTA Balloon Catheter., Experimental: Tri-wire Peripheral Balloon Dilatation Catheter |
Primary outcome
Technical Success
Time frame: Right after operation
The target lesion residual stenosis<30%
8 secondary outcomes
Device Success
Time frame: Right after operation
Procedural Success
Time frame: 12-48 hours
Dilating Pressure
Time frame: During the operation
Pain Score
Time frame: Right after operation
Target Lesion Primary Patency (TLPP)
Time frame: 1 month
Target lesion restenosis
Time frame: 1 month
Fistula Blood Flow
Time frame: 1 month
Adverse Events
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: No
Related trials for Arteriovenous Fistula
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Enrolling by invitationObservational study
Okami Medical ALPHA Registry
Arterial Bleed, Pulmonary Arteriovenous Malformation
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qizhuang Jin principal investigator
Peking University First Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter in people with Arteriovenous Fistula, run by BrosMed Medical Co., Ltd at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qizhuang Jin (13301011122, jinqizhuang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: Right after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.