REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
NCT ID: NCT00631540
Last Updated: 2013-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2008-02-29
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
renal artery stenting
Formula Balloon-Expandable Stent
renal artery stenting
Interventions
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Formula Balloon-Expandable Stent
renal artery stenting
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* appropriate size and location of the lesion
* suboptimal angioplasty
Exclusion Criteria
* failure or inability to give informed consent
* simultaneously participating in another drug or device study
18 Years
ALL
No
Sponsors
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Cook Group Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Bersin, MD
Role: PRINCIPAL_INVESTIGATOR
Swedish Medical Center
Locations
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Munroe Regional Medical Center
Ocala, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Lenox Hill Hospital
New York, New York, United States
Wake Med Raleigh Campus
Raleigh, North Carolina, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Pinnacle Health at Harrisburg
Harrisburg, Pennsylvania, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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References
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Bersin RM, Ansel G, Rizzo A, Bob Smouse H, Sinha S, Sachar R, Dave R, Weinstock BS, Feldman R, Roubin GS. Nine-month results of the REFORM study: a prospective, single-arm, multicenter clinical study of the safety and effectiveness of the Formula balloon-expandable stent for treatment of renal artery stenosis. Catheter Cardiovasc Interv. 2013 Aug 1;82(2):266-73. doi: 10.1002/ccd.24481. Epub 2013 Mar 25.
Other Identifiers
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FRUS
Identifier Type: -
Identifier Source: secondary_id
06-581
Identifier Type: -
Identifier Source: org_study_id