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STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)

NCT01927068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 499

Last updated 2023-03-24

Study results available
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Summary

Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries.

Cohort 2: To evaluate this patient population for treatment of in-stent restenotic lesions.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)

Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.

Sponsors & Collaborators

  • Spectranetics Corporation

    lead INDUSTRY

Principal Investigators

  • Thomas Zeller, MBChB, FRANZCR · Herz-Zentrum Bad Krozingen, Germany

  • Andrew Holden, MD · Auckland Hospital, New Zealand

  • Yann Goueffic, MD · Hopital Nord Laennec, France

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2020-08-31
Completion
2022-08-31
FDA Device
Yes

Countries

  • Australia
  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • New Zealand
  • Poland
  • Spain
  • United Kingdom

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 NCT01927068 on ClinicalTrials.gov