NCT02237066

Understanding Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging

Understanding the Mechanism of Peripheral Arterial Balloon Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging

• Status: Withdrawn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

Summary

The purpose of this study is to compare the Chocolate PTA Balloon to standard Percutaneous Transluminal Angioplasty (PTA) catheters. The investigators will use Optical Coherence Tomography (OCT) and Quantitative Vascular Angiography to evaluate the acute vascular response of vessels treated with the Chocolate Balloon to a standard balloon catheter, with the primary endpoint being luminal gain assessed by OCT lumen volume measurements.

Detailed description

Subjects will be randomized to treatment with either the Chocolate Balloon catheter or a standard balloon angioplasty catheter. All angioplasty procedures will be conducted with treatment balloon at the full discretion of the physician and according to the standard practice at the hospital and the device Instructions for Use. All patients will undergo baseline OCT imaging in addition to standard angiography. Post-PTA, all patients will then undergo repeat OCT imaging immediately post-procedure and then again at 10-minutes post-procedure to assess for vascular recoil.

Conditions

• Infrainguinal Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Chocolate PTA Balloon Angioplasty	OCT imaging of diseased vessel is treated with an Angioplasty Procedure using the Chocolate PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later
DEVICE	Standard PTA Balloon Angioplasty	OCT imaging of diseased vessel is treated with an Angioplasty Procedure using a standard PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-09-11
• Last updated: 2015-03-19

Locations

2 sites across 1 country: United States