MedTrace Logo

ILLUMENATE Below-The-Knee (BTK) Arteries: a Post Market Clinical Study

NCT03395236 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-01-24

No results posted yet for this study

Summary

The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the StellarexTM 0.014" OTW Drug-coated Angioplasty Balloon in the treatment of lesions in "below the knee" popliteal (P3 segment) and infra-popliteal arteries according to the Instructions for Use in Rutherford-Becker Classification (RCC) 3, 4 and 5 patient populations. This study will be conducted in Europe across up to 10 centers in up to 75 subjects. Office visits will occur at 30 days, 6, 12, and 24 months post-index procedure.

Conditions

  • Peripheral Arterial Disease

Interventions

COMBINATION_PRODUCT

StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon

The Stellarex balloon (0.014") is indicated for the treatment of de-novo or re-stenotic lesions in the lower extremities to establish blood flow and to maintain vessel patency.

Sponsors & Collaborators

  • Spectranetics Corporation

    lead INDUSTRY

Principal Investigators

  • Gunnar Tepe, MD · Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum Rosenheim

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-20
Primary Completion
2023-08-23
Completion
2023-08-23
FDA Drug
Yes
FDA Device
Yes

Countries

  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

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 NCT03395236 on ClinicalTrials.gov