Status:
UNKNOWN
Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula
Lead Sponsor:
BrosMed Medical Co., Ltd
Collaborating Sponsors:
CCRF Inc., Beijing, China
Conditions:
Arteriovenous Fistula
Eligibility:
All Genders
18+ years
Phase:
NA
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 Cathe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT04393688
Start Date
May 25 2020
End Date
May 1 2021
Last Update
May 20 2020
Active Locations (7)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
2
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100730
3
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China, 510630
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052