ILLUMENATE EU Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Claudication; Peripheral Arterial Disease
• Interventions: Device: Bare Percutaneous Transluminal Angioplasty Balloon Catheter; Device: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

• Registration Number: NCT01858363
• Lead Sponsor: Spectranetics Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-21
• Primary Completion: 2016-03
• Results First Submitted: 2017-09-07
• Study Completion: 2020-10
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-11
• Last Update Submitted: 2021-10-11
• Results First Posted: 2021-10-13
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

• Symptomatic leg ischemia requiring treatment of the superficial femoral or popliteal arteries
• Rutherford clinical category 2, 3 or 4
• Male or non-pregnant female at least 18 years

Exclusion Criteria

• Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
• Known intolerance of study medications, paclitaxel or contrast agent
• Active participation in another investigational device or drug study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bare balloon	Bare Percutaneous Transluminal Angioplasty Balloon Catheter	Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.
Paclitaxel-coated balloon	CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.

Primary Outcome Measures

Name	Time	Method
Patency at 12-months	12 months	The primary efficacy endpoint was patency at 12 months post-procedure defined as the absence of target lesion restenosis determined by duplex ultrasound peak systolic velocity ratio (PSVR) ≤2.5 and freedom from clinically-driven target lesion revascularization (CD-TLR).
Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month	30-Days and 12-Months	The primary safety endpoint was freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 12 months post-procedure.

Trial Locations

Locations (1)

Center for Diagnostic Radiology and Minimally Invasive Therapy; 🇩🇪 Berlin, Germany