The objective of this post-market clinical study is to obtain additional data on the safety and performance of the All'InCath 035M Balloon Dilatation Catheter when used per its Instructions for Use (IFU) during percutaneous transluminal angioplasty procedures in clinical practice.
The All'InCath Contrast Balloon Catheter 035M Balloon Dilatation Catheter has received 510(k) clearance for Percutaneous Transluminal Angioplasty in the peripheral vasculature, for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, and angiographic visualization of the vasculature when combined with the delivery of radiopaque contrast media (K191275). The objective of this post-market clinical study is to obtain additional data on the safety and performance of the All'InCath 035M Balloon Dilatation Catheter, including device-related perioperative adverse events, vascular patency, visualization of the target area, duration of intervention, level of radiation exposure, dose of contrast agent, post-procedural adverse events and physician's feedback, 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
All participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography.
UPMC
Pittsburgh, Pennsylvania, United States
Periprocedural Serious adverse events
Freedom from device related periprocedural adverse events and complications during PTA procedure (e.g., loss of guidewire, misdirection of catheter, vessel wall perforation or dissection requiring treatment).
Time frame: During procedure
Vascular patency
Vascular patency immediately post-procedure with adequate capability to ensure injection medium contrast into the vessel with a good visualization of the targeted area.
Time frame: immediately post-procedure
Duration of the intervention (PTA)
Performance of the All'InCath Contrast Balloon Catheter 035M
Time frame: Time of the procedure
Level of radiation exposure during PTA (mGy).
Efficiency and Safety of the All'InCath Contrast Balloon Catheter 035M
Time frame: During procedure
Dose of contrast agent injected at the targeted location (mL).
Safety and performance of the All'InCath Contrast Balloon Catheter 035M
Time frame: During procedure
Investigator's feedback
Evaluation of the function of the All'InCath Contrast Balloon Catheter 035M
Time frame: During procedure
Major adverse events during hospitalization until discharge
Safety of the All'InCath Contrast Balloon Catheter 035M
Time frame: before hospital discharge or 24hours after the index-procedure which ever occurs first
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