Trials / Terminated
TerminatedNCT05153421
Evaluation of All'InCath in Peripheral Vasculature Percutaneous Transluminal Angioplasty.
Clinical Evaluation of the All'InCath CBC 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- NexStep Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities.
Detailed description
The purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities when used per its Instructions for Use (IFU) during percutaneous transluminal angioplasty procedures in clinical practice.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | All'InCath CBC 035M Balloon Dilatation Catheter | Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter. |
Timeline
- Start date
- 2021-05-06
- Primary completion
- 2024-12-06
- Completion
- 2024-12-06
- First posted
- 2021-12-10
- Last updated
- 2025-01-28
Locations
1 site across 1 country: France
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05153421. Inclusion in this directory is not an endorsement.