Formula PTX Renal Stent Clinical Study

Renal Artery Stenosis Clinical Trial

Official title:

Evaluation of Safety and Effectiveness of the Formula PTX Balloon-Expandable Stent for Renal Artery Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057316
• Other study ID #: 06-008
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: April 9, 2018

Study information

• Verified date: May 2018
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 9, 2018
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Renal Artery Obstruction
• Renal Artery Stenosis

Intervention

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.
• Formula PTX Stent - Dose 2
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.
• Formula PTX Stent - Dose 3
Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava-Poruba
Czechia	Institute for Clinical and Experimental Medicine	Prague
France	Hopital Europeen Georges Pomidou	Paris
Germany	Herz-Zentrum Bad Krozingen	Bad Krozingen
Germany	Krankenhaus Neu-Bethlehem	Göttingen
Germany	Uniklinik Heidelberg	Heidelberg
Germany	Universitatsklinikum Leipzig AoR	Leipzig
Germany	St. Bonifatius Hospital	Lingen
Germany	Klinik Dr. Hancken im Elbe Klinikum Stade	Stade
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Kent & Canterbury Hospital	Canterbury
United Kingdom	St. Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Cook Group Incorporated

Countries where clinical trial is conducted

Czechia,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Diameter Stenosis of the Treated Renal Artery		9 months