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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography with single balloon dilatation catheter.
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Safety of the All'InCath Contrast Balloon Catheter 035M
Periprocedural Serious Adverse Events
Time frame: immediately post-procedure
Performance and effectiveness of the All'InCath Contrast Balloon Catheter 035M
Vascular patency
Time frame: immediately post-procedure
Performance of the All'InCath Contrast Balloon Catheter 035M
Duration of the PTA procedure.
Time frame: Time of Procedure
Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M
Investigator opinion
Time frame: During Procedure
Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M
Level of radiation exposure during the PTA (mGy).
Time frame: During Procedure
Safety and performance of the All'InCath Contrast Balloon Catheter 035M
Dose of injected contrast medium at the targeted location (mL)
Time frame: During Procedure
Safety of the All'InCath Contrast Balloon Catheter 035M
Post procedural adverse events
Time frame: 3 days
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