Vascular Access ComplicationNCT02297308

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

An observational study of Vascular Access Complication, run by Terumo Medical Corporation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vascular Access Complication
How many people: 90 participants
Where: 1 siteCanada
Study dates: Oct 2014to Apr 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Montreal Heart Institute
Montreal, Ontario

Other trials in Canada

About this study

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

Read the 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.

Conditions: Vascular Access Complication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02297308
Study group	Role	What they receive
SoloPath Sheath		The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access

What is being measured

The primary outcome is the main question the study is designed to answer.

Vascular Access Site Complications
Rate of VARC-2 defined vascular complications within 30 days of TAVI.
Measured: withn 30 days of TAVI procedure

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Apr 2015

First posted21 Nov 2014 (estimated)
Study startOct 2014
Primary completionMar 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02297308
Sponsor's protocol ID: TIS2014-001
Status last verified: Jan 2016
First submitted: 21 Oct 2014
Last updated: 18 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vascular Access Complication trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02297308
Acronym / sponsor ID: TIS2014-001
Conditions: Vascular Access Complication
Study type: Observational
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Terumo Medical CorporationIndustry (pharma, biotech, devices)
Collaborators: Montreal Heart Institute
Study start: Oct 2014
Primary completion: Mar 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 21 Nov 2014 (estimated)
Results: Posted 18 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

1 secondary outcome

Bleeding Complications at the Access Site
Time frame: within 30 days of TAVI procedure

Results and safety

Results posted to the registry on 18 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SoloPath Sheath	90	90

Primary outcome: Vascular Access Site Complications

Time frame: withn 30 days of TAVI procedure. Number. Unit: participants

Measure	SoloPath Sheath n = 90
Value	17

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were not assessed as this was a retrospective study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SoloPath Sheath	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Single center, retrospective data analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Vascular Access Complication

Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Not yet recruiting
Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care
Vascular Access Devices, Vascular Access
RecruitingObservational study
Mobilisation After Endovascular Stroke Treatment
Stroke, Acute Ischemic Stroke
RecruitingPhase 2
The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas
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Recruiting
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Type 1 Diabetes, Type 2 Diabetes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anita Asagr, M.D. principal investigator

Montreal Heart Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Vascular Access Complication, run by Terumo Medical Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vascular Access Site Complications (time frame: withn 30 days of TAVI procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02297308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.