NCT01057316

Formula PTX Renal Stent Clinical Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Cook Group Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Artery Stenosis

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-01-01
• Completion: 2018-04-09
• First posted: 2010-01-27
• Last updated: 2018-06-01

Locations

12 sites across 4 countries: Czechia, France, Germany, United Kingdom