Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

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Conditions studied: Critical Limb Ischemia

In brief

The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.

Key facts

Study ID

NCT03175744

Run by

Spectranetics Corporation

People needed

82

Starts

2017-05-24

Expected to finish

2025-10-01

Last updated by the study team

2023-06-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Rutherford Clinical Category 4-5
• Life expectancy > 1 year
• Significant stenosis ≥70%
• Patent inflow artery
• Target vessel(s) diameter between 2 and 4 mm
• Target vessel(s) reconstitute(s) at the ankle

You may not qualify if…

• Pregnant or planning to become pregnant
• History of stroke within 3 months
• Planned major amputation
• eGFR <30
• Acute limb ischemia
• Prior stent placement in target lesion

Where it is running

• St. Joseph Hospital — Orange, California, United States
• Bradenton Cardiology Center — Bradenton, Florida, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• University Hospitals, Cleveland Medical Center — Cleveland, Ohio, United States
• Bryn Mawr Hospital — Bryn Mawr, Pennsylvania, United States
• Pinnacle Health Cardiovascular Institute — Wormleysburg, Pennsylvania, United States
• Greenville Health System — Greenville, South Carolina, United States
• Flinders Medical Center — Bedford Park, Australia
• Sir Charles Gairdner Hospital — Perth, Australia
• LKH Universitatsklinik Graz — Graz, Austria
• Medizinische Universitat Wien — Vienna, Austria
• Imelda Ziekenhuis — Bonheiden, Belgium
• ZOL St. jan — Genk, Belgium
• University Hospital Gent — Ghent, Belgium
• Klinikum Hoschsauerland GmbH — Arnsberg, Germany
• Universitats-Herzzentrum Freiburg-Bad Krozingen — Bad Krozingen, Germany
• SRH Klinikum Karlsbad — Karlsbad, Germany
• Universitatsklink Leipzig — Leipzig, Germany
• University Hospital of Tuebingen — Tübingen, Germany

Full record on ClinicalTrials.gov

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