Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula

May 18, 2020 updated by: BrosMed Medical Co., Ltd

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Beijing
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • The First Affiliated Hospital of Jinan University
        • Contact:
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450052
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical university
        • Contact:
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Longhua Hospital Shanghai University of Traditional Chinese Medicine
        • Contact:
        • Contact:
    • Zhengjiang
      • Hangzhou, Zhengjiang, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Device: OHICHO Ⅱ PTA Balloon Catheter
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:
  • Device: OHICHO Ⅱ PTA Balloon Catheter

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%
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
Base on the technical success, without MAE including death, thrombosis, allergic reactions, pulmonary diseases (pulmonary edema)
12-48 hours
Dilating Pressure
Time Frame: During the operation
The minimum pressure with which the balloon can be completely inflated without waist during the operation
During the operation
Pain Score
Time Frame: Right after operation
The pain during dilating procedure, measured by NRS (increase from 0 to 10)
Right after operation
Target Lesion Primary Patency (TLPP)
Time Frame: 1 month
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.
1 month
Target lesion restenosis
Time Frame: 1 month
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
Fistula Blood Flow
Time Frame: 1 month
Measured Brachial artery blood flow of arteriovenous fistula flow assessed by DUS.
1 month
Adverse Events
Time Frame: 1 month
Number of device and procedure related adverse events (CEC Adjudicated)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Qizhuang Jin, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 25, 2020

Primary Completion (ANTICIPATED)

July 1, 2020

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (ACTUAL)

May 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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