Arteriovenous Fistula
Conditions
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.
Interventions
COMBINATION_PRODUCTCombination 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.
Sponsors
CCRF Inc., Beijing, China
BrosMed Medical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Right after operation | The target lesion residual stenosis\<30% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | Right after operation | During the operation, Balloon dilatation catheters can be delivered to the target lesion, inflated≤RBP without rupture and withdrawed successfully |
| Procedural Success | 12-48 hours | Base on the technical success, without MAE including death, thrombosis, allergic reactions, pulmonary diseases (pulmonary edema) |
| Pain Score | Right after operation | The pain during dilating procedure, measured by NRS (increase from 0 to 10) |
| Dilating Pressure | During the operation | The minimum pressure with which the balloon can be completely inflated without waist during the operation |
| Target lesion restenosis | 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 |
| Fistula Blood Flow | 1 month | Measured Brachial artery blood flow of arteriovenous fistula flow assessed by DUS. |
| Adverse Events | 1 month | Number of device and procedure related adverse events (CEC Adjudicated) |
| Target Lesion Primary Patency (TLPP) | 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. |
Countries
China
Contacts
Primary ContactQizhuang Jin
Backup ContactYanqi Yin
Outcome results
None listed