NCT01858363

ILLUMENATE EU Randomized Clinical Trial

Prospective, Randomized, Multi-center, Single-blinded Study for the Treatment of Subjects Presenting With De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using Paclitaxel or Bare Percutaneous Transluminal Angioplasty Balloon Catheter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Spectranetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.

Conditions

• Peripheral Arterial Disease
• Claudication

Interventions

Type	Name	Description
DEVICE	CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
DEVICE	Bare Percutaneous Transluminal Angioplasty Balloon Catheter

Timeline

• Start date: 2012-11-01
• Primary completion: 2016-03-01
• Completion: 2020-10-01
• First posted: 2013-05-21
• Last updated: 2021-10-13
• Results posted: 2021-10-13

Locations

1 site across 1 country: Germany