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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01057316 |
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Date of registration:
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25/01/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Formula PTX Renal Stent Clinical Study
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Scientific title:
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Evaluation of Safety and Effectiveness of the Formula PTX Balloon-Expandable Stent for Renal Artery Stenosis |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01057316 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Austria
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Czech Republic
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Czechia
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France
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Germany
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United Kingdom
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Renal Artery Stenosis
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Intervention(s)
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Device: Formula PTX Stent - Dose 2
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Device: Formula PTX Stent - Dose 1
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Device: Formula PTX Stent - Dose 3
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Primary Outcome(s)
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Percent Diameter Stenosis of the Treated Renal Artery
[Time Frame: 9 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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