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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COMPLETED
NA
120 participants
INTERVENTIONAL
2010-02-28
2018-04-09
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
QUADRUPLE
Study Groups
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Study Group A
Formula PTX Stent - Dose 1
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Study Group B
Formula PTX Stent - Dose 2
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Study Group C
Formula PTX Stent - Dose 3
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Interventions
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Formula PTX Stent - Dose 1
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Formula PTX Stent - Dose 2
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Formula PTX Stent - Dose 3
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Eligibility Criteria
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Inclusion Criteria
* appropriate size and location of the lesion
Exclusion Criteria
* failure or inability to give informed consent
* simultaneously participating in another drug or device study
18 Years
ALL
No
Sponsors
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Cook Group Incorporated
INDUSTRY
Responsible Party
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Locations
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University Hospital Ostrava
Ostrava-Poruba, , Czechia
Institute for Clinical and Experimental Medicine
Prague, , Czechia
Hopital Europeen Georges Pomidou
Paris, , France
Herz-Zentrum Bad Krozingen
Bad Krozingen, , Germany
Krankenhaus Neu-Bethlehem
Göttingen, , Germany
Uniklinik Heidelberg
Heidelberg, , Germany
Universitatsklinikum Leipzig AoR
Leipzig, , Germany
St. Bonifatius Hospital
Lingen, , Germany
Klinik Dr. Hancken im Elbe Klinikum Stade
Stade, , Germany
Royal Sussex County Hospital
Brighton, , United Kingdom
Kent & Canterbury Hospital
Canterbury, , United Kingdom
St. Mary's Hospital
London, , United Kingdom
Countries
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Other Identifiers
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06-008
Identifier Type: -
Identifier Source: org_study_id
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