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ILLUMENATE EU Randomized Clinical Trial

NCT01858363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2021-10-13

Study results available
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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

DEVICE

CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

DEVICE

Bare Percutaneous Transluminal Angioplasty Balloon Catheter

Sponsors & Collaborators

  • Spectranetics Corporation

    lead INDUSTRY

Principal Investigators

  • Henrik Schroeder, M.D. · Center for Diagnostic Radiology & Minimally Invasive Therapy, The Jewish Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-03-31
Completion
2020-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01858363 on ClinicalTrials.gov