Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Formula PTX Renal Stent Clinical Study

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Cook Identifier:
First received: January 25, 2010
Last updated: December 19, 2014
Last verified: December 2014

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: Double Blind (Subject, Caregiver, 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:

Primary Outcome Measures:
  • Percent Diameter Stenosis of the Treated Renal Artery [ Time Frame: 9 months ] [ Designated as safety issue: No ]

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01057316

Czech Republic
University Hospital Ostrava
Ostrava-Poruba, Czech Republic, 70852
Institute for Clinical and Experimental Medicine
Prague, Czech Republic
Hopital Europeen Georges Pomidou
Paris, France
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
  More Information

No publications provided

Responsible Party: Cook Identifier: NCT01057316     History of Changes
Other Study ID Numbers: 06-008
Study First Received: January 25, 2010
Last Updated: December 19, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: German Institute of Medical Documentation and Information
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Austria: Federal Office for Safety in Health Care
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Renal Artery Obstruction
Arterial Occlusive Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Vascular Diseases processed this record on March 01, 2015