Carotid Artery StenosisNCT03816202

Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)

An observational study of Carotid Artery Stenosis, run by Integra LifeSciences Corporation at 3 sites in United States.

Completed

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

Trial summary

The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Carotid Artery Stenosis
What is being tested?: Sundt carotid shunt
Type of treatment: Medical device
How many people: 100 participants
Where: 3 sitesUnited States
Study dates: 25 Apr 2019to 27 Aug 2019
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects participating in the study have undergone a carotid endarterectomy procedure with the use of the Sundt™ carotid shunt prior to study initiation.

Who may be able to join

Between the ages of 18-80 years old
Have undergone carotid endarterectomy with any Integra Sundt™ carotid shunt on or before date of study initiation
Availability of records on post-operative imaging of the carotid artery either by carotid duplex ultrasound or angiogram

Who cannot join

Insertion of a carotid shunt at the site of an infection

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Hackensack Meridian Health
Hackensack, New Jersey, 07601
The Mount Sinai Medical Center
New York, New York, 10029
Research Institute of Deaconess Clinic
Newburgh, Indiana, 47630

Other trials in United States

About this study

The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.

Conditions: Carotid Artery Stenosis
Being tested: Sundt carotid shunt
Medical subject headings: Carotid Stenosis

What participants receive

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

Sundt carotid shuntDevice
The Integra Sundt™ carotid shunts are indicated for temporary carotid artery bypass during carotid endarterectomy procedures to help protect the cerebral hemispheres from ischemia during the period of carotid artery occlusion.

Study groups in NCT03816202
Study group	Role	What they receive
Sundt Carotid Shunt		Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt. Receives: Device: Sundt carotid shunt

What is being measured

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

Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal
Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal
Measured: up to 60 days post-procedure

Timeline

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

25 Apr 201927 Aug 2019

First posted25 Jan 2019
Study start25 Apr 2019
Primary completion27 Aug 2019
Study completion27 Aug 2019

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 Carotid Artery 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: Other
Time perspective: Retrospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03816202
Sponsor's protocol ID: C-SCS-001
Status last verified: Jan 2022
First submitted: 22 Jan 2019
Last updated: 14 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
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

Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
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PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
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A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
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Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

All Carotid Artery Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
ClinicalTrials.gov ID: NCT03816202
Acronym / sponsor ID: C-SCS-001
Conditions: Carotid Artery Stenosis
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Study start: 25 Apr 2019 (actual)
Primary completion: 27 Aug 2019 (actual)
Study completion: 27 Aug 2019 (actual)
First posted: 25 Jan 2019 (actual)
Results: Posted 14 Jan 2022

Clinical summary

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

The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.

Study design

Observational model: Other
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Sundt Carotid Shunt	–	Device: Sundt carotid shuntSubject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects participating in the study have undergone a carotid endarterectomy procedure with the use of the Sundt™ carotid shunt prior to study initiation.

Key inclusion criteria (3 listed)

Between the ages of 18-80 years old
Have undergone carotid endarterectomy with any Integra Sundt™ carotid shunt on or before date of study initiation
Availability of records on post-operative imaging of the carotid artery either by carotid duplex ultrasound or angiogram

Key exclusion criteria (1 listed)

Insertion of a carotid shunt at the site of an infection

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
Sundt carotid shuntThe Integra Sundt™ carotid shunts are indicated for temporary carotid artery bypass during carotid endarterectomy procedures to help protect the cerebral hemispheres from ischemia during the period of carotid artery occlusion.	Device	Sundt Carotid Shunt

Primary outcome

Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal
Time frame: up to 60 days post-procedure
Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal

Results and safety

Results posted to the registry on 14 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sundt Carotid Shunt	100	100

Primary outcome: Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal

Time frame: up to 60 days post-procedure. Count of participants. Unit: Participants

Measure	Sundt Carotid Shunt n = 100
Value	3

Population analysed: number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal

Adverse events

Time frame: Retrospective chart review of AEs that occurred between Surgery (Day 0) and 60 days post-operatively.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sundt Carotid Shunt	0 of 100 (0%)	3 of 100 (3%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Carotid Artery Stenosis

Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingObservational study
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

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.

Andrew Tummon study director

Integra LifeSciences

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

Questions about this trial

What is this clinical trial studying?

An observational study of Carotid Artery Stenosis, run by Integra LifeSciences Corporation at 3 sites in United States.

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 3 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 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 14 Jan 2022). 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?

Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal (time frame: up to 60 days post-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 NCT03816202.

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 14 Jan 2022.