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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
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Artery Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 25, 2010
Last Updated
May 31, 2018
Sponsor
Cook Group Incorporated
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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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