NCT05497440

Evaluation of All'InCath in Peripheral Vasculature Percutaneous Transluminal Angioplasty.

Clinical Evaluation of the All'InCath Contrast Balloon Catheter 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NexStep Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vascular Diseases

Interventions

Type	Name	Description
DEVICE	All'InCath CBC 035M Balloon Dilatation Catheter	All participants will undergo the same intervention. Peripheral Vasculature Percutaneous Transluminal Angioplasty and Control Angiography.

Timeline

• Start date: 2022-07-07
• Primary completion: 2022-10-07
• Completion: 2022-10-07
• First posted: 2022-08-11
• Last updated: 2025-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study