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

Vascular Access Complication Clinical Trial

Official title:

A Single Center, Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications After Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297308
• Other study ID #: TIS2014-001
• Status: Completed
• Phase: N/A
• First received: October 21, 2014
• Last updated: January 21, 2016
• Start date: October 2014
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: Terumo Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Vascular Access Complication

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Terumo Medical Corporation	Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular Access Site Complications	Rate of VARC-2 defined vascular complications within 30 days of TAVI.	withn 30 days of TAVI procedure	Yes
Secondary	Bleeding Complications at the Access Site	VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding	within 30 days of TAVI procedure	Yes