Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
NCT ID: NCT03175744
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
82 participants
INTERVENTIONAL
2017-05-24
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Stellarex DCB
Spectranetics Stellarex Drug Coated Balloon
Stellarex DCB
Intervention with the Stellarex DCB
PTA Catheter
Standard Uncoated Balloon Angioplasty Catheter
PTA Catheter
Intervention with an uncoated Standard PTA
Interventions
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Stellarex DCB
Intervention with the Stellarex DCB
PTA Catheter
Intervention with an uncoated Standard PTA
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* History of stroke within 3 months
* Planned major amputation
* eGFR \<30
* Acute limb ischemia
* Prior stent placement in target lesion
18 Years
85 Years
ALL
No
Sponsors
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Philips Healthcare
INDUSTRY
Spectranetics Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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William Gray, MD
Role: PRINCIPAL_INVESTIGATOR
Lankenau Heart Institute
Mahmood K Razavi, MD
Role: PRINCIPAL_INVESTIGATOR
Vascular and Interventional Specialists of Orange
Dierk Scheinert, MD
Role: PRINCIPAL_INVESTIGATOR
University of Leipzig
Locations
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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
Countries
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Other Identifiers
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D032150
Identifier Type: -
Identifier Source: org_study_id
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