ILLUMENATE EU Randomized Clinical Trial

Spectranetics Corporation294 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

294

Conditions

Peripheral Arterial Disease Claudication

Interventions

CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterDEVICE

Bare Percutaneous Transluminal Angioplasty Balloon CatheterDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Center for Diagnostic Radiology and Minimally Invasive Therapy

Berlin, Germany

Outcomes

Primary Outcomes

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).

Time frame: 12 months

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.

Time frame: 30-Days and 12-Months

Data from ClinicalTrials.gov

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