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OpenTrials
Completed

NCT Number: NCT02297308

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

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.

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Key information

Conditions

Vascular Access Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal Heart Institute

Montreal, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Bleeding Complications at the Access Site

    Time frame: within 30 days of TAVI procedure

    VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding

Sponsors and collaborators

Lead sponsor

Terumo Medical Corporation

Industry

Collaborators

  • Montreal Heart Institute

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2014
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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