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ILLUMENATE Pivotal Post-Approval Study (PAS)

NCT03421561 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-02-02

Study results available
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Summary

The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.

Conditions

Interventions

DEVICE

Stellarex 0.035" OTW Drug-coated Angioplasty Balloon

The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.

DEVICE

EverCross™ 0.035 PTA Balloon Catheter

The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).

Sponsors & Collaborators

  • Spectranetics Corporation

    lead INDUSTRY

Principal Investigators

  • Sean Lyden, MD · The Cleveland Clinic

  • Prakash Krishnan, MD · Mount Sinai Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-18
Primary Completion
2017-12-08
Completion
2020-10-06
FDA Device
Yes

Countries

  • United States
  • Austria

Study Locations

More Related Trials

Entities

Diseases

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 NCT03421561 on ClinicalTrials.gov