Formula PTX Renal Stent Clinical Study

Not Applicable

Completed

• Conditions: Renal Artery Stenosis
• Interventions: Device: Formula PTX Stent - Dose 3; Device: Formula PTX Stent - Dose 1; Device: Formula PTX Stent - Dose 2

• Registration Number: NCT01057316
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-27
• Study Start: 2010-02
• Primary Completion: 2014-01
• Study Completion: 2018-04-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group C	Formula PTX Stent - Dose 3	-
Study Group A	Formula PTX Stent - Dose 1	-
Study Group B	Formula PTX Stent - Dose 2	-

Primary Outcome Measures

Name	Time	Method
Percent Diameter Stenosis of the Treated Renal Artery	9 months

Trial Locations

Locations (12)

University Hospital Ostrava; 🇨🇿 Ostrava-Poruba, Czechia

Royal Sussex County Hospital; 🇬🇧 Brighton, United Kingdom

St. Bonifatius Hospital; 🇩🇪 Lingen, Germany

Institute for Clinical and Experimental Medicine; 🇨🇿 Prague, Czechia

Herz-Zentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Kent & Canterbury Hospital; 🇬🇧 Canterbury, United Kingdom

Hopital Europeen Georges Pomidou; 🇫🇷 Paris, France

St. Mary's Hospital; 🇬🇧 London, United Kingdom

Klinik Dr. Hancken im Elbe Klinikum Stade; 🇩🇪 Stade, Germany

Krankenhaus Neu-Bethlehem; 🇩🇪 Göttingen, Germany

Uniklinik Heidelberg; 🇩🇪 Heidelberg, Germany

Universitatsklinikum Leipzig AoR; 🇩🇪 Leipzig, Germany