NCT02424383

Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter

A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter in Arteries of the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) (SAFE-DCB U.S. Registry)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,005 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.

Detailed description

The registry is a prospective, multicenter, single arm post-market real-world registry in the U.S. assessing the clinical use, safety and outcomes of the Lutonix 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA). Registry subjects will be followed for up to three year's post-index procedure.

Conditions

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Arterial Occlusive Diseases

Interventions

Type	Name	Description
DEVICE	PTA (Lutonix® 035 DCB Catheter)	Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough. The Lutonix® DCB through the blood vessel to the narrowed area to be treated.

Timeline

• Start date: 2015-04-23
• Primary completion: 2017-10-27
• Completion: 2019-10-21
• First posted: 2015-04-23
• Last updated: 2020-05-22
• Results posted: 2020-05-22

Locations

73 sites across 1 country: United States