A Single Center, Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications After Transcatheter Aortic Valve Implantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Terumo Medical Corporation
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Vascular Access Site Complications
Study Overview
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 vascular access.
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 introduction and delivery of TAVI devices. The use of a small profile sheath could possibly reduce the incidence of post procedure vascular complications associated with TAVI and further enhance the safety of accessing the femoral delivery route.
In addition, this study will examine the impact of arterial morphology and other subject risk factors as a predictor of clinical outcomes within 30 days following TAVI.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Vascular Access Site Complications
Time Frame: withn 30 days of TAVI procedure
Rate of VARC-2 defined vascular complications within 30 days of TAVI.
Secondary Outcomes
- Bleeding Complications at the Access Site(within 30 days of TAVI procedure)