ClinicalTrials.gov
ClinicalTrials.gov Menu

Formula PTX Renal Stent Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01057316
Recruitment Status : Active, not recruiting
First Posted : January 27, 2010
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

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.

Condition or disease Intervention/treatment Phase
Renal Artery Stenosis Device: Formula PTX Stent - Dose 1 Device: Formula PTX Stent - Dose 2 Device: Formula PTX Stent - Dose 3 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Effectiveness of the Formula PTX Balloon-Expandable Stent for Renal Artery Stenosis
Study Start Date : February 2010
Actual Primary Completion Date : January 2014
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Study Group A Device: Formula PTX Stent - Dose 1
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Experimental: Study Group B Device: Formula PTX Stent - Dose 2
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
Experimental: Study Group C Device: Formula PTX Stent - Dose 3
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.



Primary Outcome Measures :
  1. Percent Diameter Stenosis of the Treated Renal Artery [ Time Frame: 9 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057316


Locations
Czechia
University Hospital Ostrava
Ostrava-Poruba, Czechia, 70852
Institute for Clinical and Experimental Medicine
Prague, Czechia
France
Hopital Europeen Georges Pomidou
Paris, France
Germany
Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Krankenhaus Neu-Bethlehem
Göttingen, Germany, 37073
Uniklinik Heidelberg
Heidelberg, Germany
Universitatsklinikum Leipzig AoR
Leipzig, Germany, 04103
St. Bonifatius Hospital
Lingen, Germany, 49808
Klinik Dr. Hancken im Elbe Klinikum Stade
Stade, Germany, 21682
United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom, BN5BE
Kent & Canterbury Hospital
Canterbury, United Kingdom, CT1 3NG
St. Mary's Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Cook Group Incorporated

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01057316     History of Changes
Other Study ID Numbers: 06-008
First Posted: January 27, 2010    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Constriction, Pathologic
Renal Artery Obstruction
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases