Trials / Unknown
UnknownNCT04393688
Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- Sponsor
- BrosMed Medical Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-05-25
- Primary completion
- 2020-07-01
- Completion
- 2021-05-01
- First posted
- 2020-05-19
- Last updated
- 2020-05-20
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04393688. Inclusion in this directory is not an endorsement.