Status:
COMPLETED
A Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications
Lead Sponsor:
Terumo Medical Corporation
Collaborating Sponsors:
Montreal Heart Institute
Conditions:
Vascular Access Complication
Eligibility:
All Genders
18+ years
Brief Summary
This study is a retrospective, single center data collection to assess bleeding and vascular complications associated with TAVI when a SoloPath® Balloon Expandable TransFemoral Introducer is used for ...
Detailed Description
This study is intended to collect data on the rate of vascular complications in subjects having transfemoral TAVI when the SoloPath® Balloon Expandable TransFemoral Introducer is used as a guide for i...
Eligibility Criteria
Inclusion
- Subject must have undergone a TAVI procedure with femoral access achieved with a 19Fr (ID) SoloPath (STFI) sheath.
- Male or female ≥ 18 years old.
Exclusion
- Subjects with Femoral or Iliac vessels less than 6mm on side of TAVI access will be excluded.
- Subjects treated before January 1, 2011, are excluded from this analysis.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02297308
Start Date
October 1 2014
End Date
April 1 2015
Last Update
February 18 2016
Active Locations (1)
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1
Montreal Heart Institute
Montreal, Ontario, Canada