Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study
NCT ID: NCT03023098
Last Updated: 2017-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2013-01-31
2016-11-30
Brief Summary
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Detailed Description
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In the procedure a conventional balloon is passed through the stenosis which is then dilated. After this patients are randomized before a second dilatation with either a conventional balloon or a drug-coated balloon.
The stenosis is evaluated preoperatively and followed up by means of ultrasound by a vascular technician. Follow-up will end at 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Drug-eluting balloon
Drug-eluting balloon
After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon
Conventional PTA
Conventional PTA
After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon
Interventions
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Conventional PTA
After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon
Drug-eluting balloon
After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Maarit Venermo
Professor of Vascular Surgery
Principal Investigators
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Maarit Venermo, M.D., Ph.D.
Role: STUDY_DIRECTOR
Helsinki University Hospital, Dept. of Vascular Surgery
Locations
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Helsinki University Hospital
Helsinki, , Finland
Countries
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References
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Bjorkman P, Kokkonen T, Alback A, Venermo M. Drug-Coated versus Plain Balloon Angioplasty in Bypass Vein Grafts (the DRECOREST I-Study). Ann Vasc Surg. 2019 Feb;55:36-44. doi: 10.1016/j.avsg.2018.04.042. Epub 2018 Aug 6.
Other Identifiers
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DRECOREST1 - Jan 23rd 2013
Identifier Type: -
Identifier Source: org_study_id
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