Formula PTX Renal Stent Clinical Study
Primary Purpose
Renal Artery Stenosis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Formula PTX Stent - Dose 1
Formula PTX Stent - Dose 2
Formula PTX Stent - Dose 3
Sponsored by
About this trial
This is an interventional treatment trial for Renal Artery Stenosis
Eligibility Criteria
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
Sites / Locations
- University Hospital Ostrava
- Institute for Clinical and Experimental Medicine
- Hopital Europeen Georges Pomidou
- Herz-Zentrum Bad Krozingen
- Krankenhaus Neu-Bethlehem
- Uniklinik Heidelberg
- Universitatsklinikum Leipzig AoR
- St. Bonifatius Hospital
- Klinik Dr. Hancken im Elbe Klinikum Stade
- Royal Sussex County Hospital
- Kent & Canterbury Hospital
- St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Study Group A
Study Group B
Study Group C
Arm Description
Outcomes
Primary Outcome Measures
Percent Diameter Stenosis of the Treated Renal Artery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01057316
Brief Title
Formula PTX Renal Stent Clinical Study
Official Title
Evaluation of Safety and Effectiveness of the Formula PTX Balloon-Expandable Stent for Renal Artery Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Artery Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group A
Arm Type
Experimental
Arm Title
Study Group B
Arm Type
Experimental
Arm Title
Study Group C
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Formula PTX Stent - Dose 1
Intervention Description
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Intervention Type
Device
Intervention Name(s)
Formula PTX Stent - Dose 2
Intervention Description
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Intervention Type
Device
Intervention Name(s)
Formula PTX Stent - Dose 3
Intervention Description
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Primary Outcome Measure Information:
Title
Percent Diameter Stenosis of the Treated Renal Artery
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Institute for Clinical and Experimental Medicine
City
Prague
Country
Czechia
Facility Name
Hopital Europeen Georges Pomidou
City
Paris
Country
France
Facility Name
Herz-Zentrum Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Krankenhaus Neu-Bethlehem
City
Göttingen
ZIP/Postal Code
37073
Country
Germany
Facility Name
Uniklinik Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Universitatsklinikum Leipzig AoR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
St. Bonifatius Hospital
City
Lingen
ZIP/Postal Code
49808
Country
Germany
Facility Name
Klinik Dr. Hancken im Elbe Klinikum Stade
City
Stade
ZIP/Postal Code
21682
Country
Germany
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN5BE
Country
United Kingdom
Facility Name
Kent & Canterbury Hospital
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Formula PTX Renal Stent Clinical Study
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