- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01057316
Formula PTX Renal Stent Clinical Study
May 31, 2018 updated by: Cook Group Incorporated
Evaluation of Safety and Effectiveness of the Formula PTX Balloon-Expandable Stent for Renal Artery Stenosis
The purpose of the study is to evaluate the safety and effectiveness of the PTX-coating on the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ostrava-Poruba, Czechia, 70852
- University Hospital Ostrava
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Prague, Czechia
- Institute for Clinical and Experimental Medicine
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Paris, France
- Hopital Europeen Georges Pomidou
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Bad Krozingen, Germany, 79189
- Herz-Zentrum Bad Krozingen
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Göttingen, Germany, 37073
- Krankenhaus Neu-Bethlehem
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Heidelberg, Germany
- Uniklinik Heidelberg
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Leipzig, Germany, 04103
- Universitätsklinikum Leipzig AöR
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Lingen, Germany, 49808
- St. Bonifatius Hospital
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Stade, Germany, 21682
- Klinik Dr. Hancken im Elbe Klinikum Stade
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Brighton, United Kingdom, BN5BE
- Royal Sussex County Hospital
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Canterbury, United Kingdom, CT1 3NG
- Kent & Canterbury Hospital
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London, United Kingdom, W2 1NY
- St. Mary's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- renal artery stenosis
- appropriate size and location of the lesion
Exclusion Criteria:
- pregnant or breast feeding
- failure or inability to give informed consent
- simultaneously participating in another drug or device study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Study Group A
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Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator).
Groups are blinded.
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Experimental: Study Group B
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Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator).
Groups are blinded.
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Experimental: Study Group C
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Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator).
Groups are blinded.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent Diameter Stenosis of the Treated Renal Artery
Time Frame: 9 months
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9 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
April 9, 2018
Study Registration Dates
First Submitted
January 25, 2010
First Submitted That Met QC Criteria
January 25, 2010
First Posted (Estimate)
January 27, 2010
Study Record Updates
Last Update Posted (Actual)
June 1, 2018
Last Update Submitted That Met QC Criteria
May 31, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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