StenosisNCT02373852

PMS Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention

An observational study of Stenosis, run by Gardia Medical at 1 site in Israel.

Completed

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

Trial summary

The objective of this study is to collect data on the use of the WIRION system in Patients undergoing Percutaneous Intervention of Saphenous Vein Graft (SVG). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stenosis
What is being tested?: Saphenous vein graft (SVG) stenting
Type of treatment: Medical device
How many people: 12 participants
Where: 1 siteIsrael
Study dates: Oct 2014to Jun 2016
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: patients undergoing percutaneous intervention (PI) of saphenous vein graft (SVG) stenting

Who may be able to join

Patients underwent percutaneous intervention (PI) of SVG stenting in which the WIRIONTM system was used.
Patient is greater than or equal to 18 years of age.

Who cannot join

Undergone cardiac surgery in the past 60 days before the procedure.

Trial locations and contacts

1 site in 1 country.

Israel1 site

Bnai Zion
Haifa

Other trials in Israel

About this study

Official title: Post Marketing Surveillance (PMS) Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention

The objective of this study is to collect data on the use of the WIRION system in Patients undergoing Percutaneous Intervention of Saphenous Vein Graft (SVG).

Read the detailed description

WIRION system is used as protection device in patients undergoing SVG stenting procedure. This retrospective study collects data on the usability of the WIRION during the procedure.

Conditions: Stenosis
Being tested: Saphenous vein graft (SVG) stenting
Medical subject headings: Constriction, Pathologic

What participants receive

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

Saphenous vein graft (SVG) stentingDevice
Opening and stenting of blocked SVG with the use of the WIRION embolic protection filter

What is being measured

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

Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure
Collect and analyse all adverse events occurred during and following the SVG procedure up to 30 days.
Measured: 30 Days
Number of Patients That Undergo Successful SVG Procedure
Successful procedure is considered as a procedure in which no distal embolization, dissection, perforation, abrupt closure or no reflow occurred.
Measured: 30 Days

Timeline

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

Oct 2014Jun 2016

First posted27 Feb 2015 (estimated)
Study startOct 2014
Primary completionMay 2015
Study completionJun 2016

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 StenosisStudies 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: Cohort
Time perspective: Retrospective
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02373852
Sponsor's protocol ID: SVG-CL003
Status last verified: Aug 2019
First submitted: 22 Sep 2014
Last updated: 12 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction

All Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Marketing Surveillance (PMS) Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention
ClinicalTrials.gov ID: NCT02373852
Acronym / sponsor ID: SVG-CL003
Conditions: Stenosis
Study type: Observational
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Gardia MedicalIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: May 2015 (actual)
Study completion: Jun 2016 (actual)
First posted: 27 Feb 2015 (estimated)
Results: Posted 12 Sep 2019

Clinical summary

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

The objective of this study is to collect data on the use of the WIRION system in Patients undergoing Percutaneous Intervention of Saphenous Vein Graft (SVG).

Detailed description

WIRION system is used as protection device in patients undergoing SVG stenting procedure. This retrospective study collects data on the usability of the WIRION during the procedure.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients undergoing percutaneous intervention (PI) of saphenous vein graft (SVG) stenting

Key inclusion criteria (2 listed)

Patients underwent percutaneous intervention (PI) of SVG stenting in which the WIRIONTM system was used.
Patient is greater than or equal to 18 years of age.

Key exclusion criteria (1 listed)

Undergone cardiac surgery in the past 60 days before the procedure.

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

Interventions

Intervention	Type	Arms
Saphenous vein graft (SVG) stentingOpening and stenting of blocked SVG with the use of the WIRION embolic protection filter	Device	–

Primary outcome

Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure
Time frame: 30 Days
Collect and analyse all adverse events occurred during and following the SVG procedure up to 30 days.
Number of Patients That Undergo Successful SVG Procedure
Time frame: 30 Days
Successful procedure is considered as a procedure in which no distal embolization, dissection, perforation, abrupt closure or no reflow occurred.

Results and safety

Results posted to the registry on 12 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
WIRION	12	11

Primary outcome: Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure

Time frame: 30 Days. Count of participants. Unit: Participants

Measure	WIRION n = 12
Value	5

Primary outcome: Number of Patients That Undergo Successful SVG Procedure

Time frame: 30 Days. Count of participants. Unit: Participants

Measure	WIRION n = 12
Value	12

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
WIRION	1 of 12 (8.3%)	4 of 12 (33.3%)	1 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Stenosis

Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction

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.

Vardit Segal, PhD study director

Gardia medical manufacture the WIRION used in the study

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 Stenosis, run by Gardia Medical at 1 site in Israel.

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 1 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 12 Sep 2019. 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 Israel. 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 12 Sep 2019). 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?

Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure (time frame: 30 Days). The study lists 2 primary outcomes in all. 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 NCT02373852.

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 12 Sep 2019.