A Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications

Completed

• Conditions: Vascular Access Complication

• Registration Number: NCT02297308
• Lead Sponsor: Terumo Medical Corporation

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-21
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Results First Submitted: 2015-11-30
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-21
• Last Update Submitted: 2016-01-21
• Results First Posted: 2016-02-18
• Last Update Posted: 2016-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Subject must have undergone a TAVI procedure with femoral access achieved with a 19Fr (ID) SoloPath (STFI) sheath.
2. Male or female ≥ 18 years old.

Exclusion Criteria

1. Subjects with Femoral or Iliac vessels less than 6mm on side of TAVI access will be excluded.
2. Subjects treated before January 1, 2011, are excluded from this analysis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vascular Access Site Complications	withn 30 days of TAVI procedure	Rate of VARC-2 defined vascular complications within 30 days of TAVI.

Secondary Outcome Measures

Name	Time	Method
Bleeding Complications at the Access Site	within 30 days of TAVI procedure	VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montreal, Ontario, Canada