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Formula PTX Renal Stent Clinical Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated
ClinicalTrials.gov Identifier:
NCT01057316
First received: January 25, 2010
Last updated: June 30, 2017
Last verified: June 2017
  Purpose
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 Intervention
Renal Artery Stenosis Device: Formula PTX Stent - Dose 1 Device: Formula PTX Stent - Dose 2 Device: Formula PTX Stent - Dose 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Cook Group Incorporated:

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

Enrollment: 120
Study Start Date: February 2010
Estimated Study Completion Date: December 2018
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01057316     History of Changes
Other Study ID Numbers: 06-008
Study First Received: January 25, 2010
Last Updated: June 30, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017