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

Arteriovenous Fistula Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04393688
• Other study ID #: BM-821
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2020
• Source: BrosMed Medical Co., Ltd
• Contact: Qizhuang Jin
• Phone: 13301011122
• Email: jinqizhuang[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 located in the upper extremity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: May 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

Combination Product:
• Combination Product: Tri-wire Peripheral Balloon Dilatation 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.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhengjiang
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Longhua Hospital Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
BrosMed Medical Co., Ltd	CCRF Inc., Beijing, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Success	The target lesion residual stenosis<30%	Right after operation
Secondary	Device Success	During the operation, Balloon dilatation catheters can be delivered to the target lesion, inflated=RBP without rupture and withdrawed successfully	Right after operation
Secondary	Procedural Success	Base on the technical success, without MAE including death, thrombosis, allergic reactions, pulmonary diseases (pulmonary edema)	12-48 hours
Secondary	Dilating Pressure	The minimum pressure with which the balloon can be completely inflated without waist during the operation	During the operation
Secondary	Pain Score	The pain during dilating procedure, measured by NRS (increase from 0 to 10)	Right after operation
Secondary	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.	1 month
Secondary	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	1 month
Secondary	Fistula Blood Flow	Measured Brachial artery blood flow of arteriovenous fistula flow assessed by DUS.	1 month
Secondary	Adverse Events	Number of device and procedure related adverse events (CEC Adjudicated)	1 month