NCT03301246

Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease

Artimes Pro Low Profile 1.00mm and 1.25mm Dilatation Catheters for Pre-Dilatation of Stenosis and Occlusion in Patients With Symptomatic Ischemic Heart Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Eminence Clinical Research, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, non-randomized, open label, multi-center study including 60 patients with symptomatic ischemic heart disease with 70%-100% coronary artery stenoses and occlusions enrolled and treated in this investigational device study.

Detailed description

Patients who require initial pre-dilatation using the study device, and then undergo definitive therapy using additional PTCA catheters and stents, according to standard of care will be enrolled in this study. A maximum of 60 subjects with native coronary artery lesions or occlusions will be treated using the Artimes pro Balloon Dilatation Catheters in a 3:1 ratio using the 1.0mm and 1.25mm dilatation catheters for pre-dilatation and will complete the study within the U.S. This equals 45 patients treated using the 1.0mm dilatation catheter, and 15 patients treated with the 1.25mm dilatation catheter for a total of 60 subjects enrolled and treated.

Conditions

• Coronary Artery Disease
• Heart Disease, Ischemic
• Coronary Stenosis

Interventions

Type	Name	Description
DEVICE	Artimes Pro Low Profile Dilatation Catheter	Pre-dilation catheter for the purpose of preparing the vessel to deliver the final therapy.

Timeline

• Start date: 2018-10-31
• Primary completion: 2020-01-29
• Completion: 2020-05-08
• First posted: 2017-10-04
• Last updated: 2020-06-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study