ILLUMENATE EU Randomized Clinical Trial

Peripheral Arterial Disease Clinical Trial

— EU RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858363
• Other study ID #: TP 1360
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: October 2020

Study information

• Verified date: October 2021
• Source: Spectranetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: October 2020
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Claudication
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

• Bare Percutaneous Transluminal Angioplasty Balloon Catheter

Locations

Country	Name	City	State
Germany	Center for Diagnostic Radiology and Minimally Invasive Therapy	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Spectranetics Corporation

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Brodmann M, Werner M, Meyer DR, Reimer P, Krüger K, Granada JF, Jaff MR, Schroeder H; ILLUMENATE EU RCT Investigators. Sustainable Antirestenosis Effect With a Low-Dose Drug-Coated Balloon: The ILLUMENATE European Randomized Clinical Trial 2-Year Results. — View Citation

Schroeder H, Werner M, Meyer DR, Reimer P, Krüger K, Jaff MR, Brodmann M; ILLUMENATE EU RCT Investigators. Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Res — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency at 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).	12 months
Primary	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	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.	30-Days and 12-Months