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OpenTrials
Completed

NCT Number: NCT01858363

ILLUMENATE EU Randomized Clinical Trial

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Claudication Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Diagnostic Radiology and Minimally Invasive Therapy

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

Device

Bare Percutaneous Transluminal Angioplasty Balloon Catheter

Device

Primary outcomes

  1. Patency at 12-months

    Time frame: 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).

  2. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Spectranetics Corporation

Industry

Registry information

Official study 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

Acronym: EU RCT

Important dates

Study start
2012
Primary completion
2016
Study completion
2020
First posted
May 21, 2013
Registry last updated
Oct 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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