At a glance
ClinicalIndex Comparison RecordN/ACompleted· 55 enrolled
Drug / intervention
MDT-2111 CoreValve for TAVIdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis
In Brief
A clinical study evaluating MDT-2111 CoreValve for TAVI for Aortic Valve Stenosis. Completed, enrolled 55 participants across 4 sites.
Detailed Summary
The primary objective of the present trial is to demonstrate the effectiveness and safety of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects deemed difficult for surgical operation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2011
Enrollment StartOct 2011
Primary CompletionApr 2013
Study CompletionNov 2018
TodayJul 2026
First PostedSep 20, 2011
Enrollment StartOct 1, 2011
Primary CompletionApr 1, 2013
Study CompletionNov 27, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.8 years ago
Interventions
MDT-2111 CoreValve for TAVIdevice
CoreValve Transcatheter Aortic Valve Implantation (TAVI) using the MDT-2111 system.