Trials / Not Yet Recruiting
Not Yet RecruitingNCT07330817
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
ULTRAVIOLET FIM_A First-In-Man Single Arm Prospective Single Center Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- Sponsor
- Cardionovum GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.
Detailed description
First-In-Man Single Site study to assess safety and efficacy of ultra-high pressure PTA balloon called ULTRAVIOLET UHP PTA in treating resistant stenotic lesions in arterio-venous fistula of dialysis patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PTA balloon | Angioplasty of a resistant stenotic lesion in the arterio-venous fistula |
Timeline
- Start date
- 2026-02-01
- Primary completion
- 2027-01-01
- Completion
- 2027-02-01
- First posted
- 2026-01-09
- Last updated
- 2026-01-09
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT07330817. Inclusion in this directory is not an endorsement.