Formula PTX Renal Stent Clinical Study

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.

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Key information

Conditions

Renal Artery Stenosis Arterial Occlusive Diseases Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Artery Obstruction Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava, Ostrava-Poruba, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Formula PTX Stent - Dose 1

Device

Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.

Formula PTX Stent - Dose 2

Device

Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.

Formula PTX Stent - Dose 3

Device

Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded.

Primary outcomes

Percent Diameter Stenosis of the Treated Renal Artery

Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2018
First posted: Jan 27, 2010
Registry last updated: Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed