NCT02297308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 18, 2016

Completed
Last Updated

February 18, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

October 21, 2014

Results QC Date

November 30, 2015

Last Update Submit

January 21, 2016

Conditions

Vascular Access Complication

Outcome Measures

Primary Outcomes (1)

  • Vascular Access Site Complications

    Rate of VARC-2 defined vascular complications within 30 days of TAVI.

    withn 30 days of TAVI procedure

Secondary Outcomes (1)

  • Bleeding Complications at the Access Site

    within 30 days of TAVI procedure

Study Arms (1)

SoloPath Sheath

The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of subjects with severe aortic stenosis who underwent TAVI utilizing the SoloPath sheath for vascular access since 2011.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute

Montreal, Ontario, Canada

Location

Limitations and Caveats

Single center, retrospective data analysis.

Results Point of Contact

Title
Robert Gash, Director of Clinical Affairs
Organization
Terumo Medical Corporation
robert.gash@terumomedical.com
732-302-4931

Study Officials

  • Anita Asagr, M.D.

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2014

First Posted

November 21, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

February 18, 2016

Results First Posted

February 18, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)