CompletedNot Applicable

REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent

United States100 participantsStarted 2008-02

Plain-language summary

The purpose of the study is to evaluate the safety and effectiveness of the Formula Balloon-Expandable Stent in treatment of renal artery stenosis.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * renal artery stenosis * appropriate size and location of the lesion * suboptimal angioplasty Key Exclusion Criteria: * less than 18 years old * failure or inability to give informed consent * simultaneously participating in another drug or device study

What they're measuring

Primary Patency of the Treated Renal Artery

Timeframe: 9 Months

Trial details

NCT IDNCT00631540

SponsorCook Group Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-05

Results submitted2011-02-11

View on ClinicalTrials.gov More Renal Artery Stenosis trials