Carotid StenosisNCT01569594
CorMatrix ECM for Carotid Repair Following Endarterectomy Registry
An observational study of Carotid Stenosis, run by Elutia Inc. at 6 sites in United States.
Trial summary
Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- CorMatrix ECM for Carotid Repair
- Type of treatment
- Medical device
- How many people
- 230 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2012to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 230 subjects may be enrolled from up to ten U.S. clinical sites
Who may be able to join
- Subjects must be undergoing carotid endarterectomy with patch angioplasty closure.
- Subject's operative surgeon intends to use CorMatrix ECM as the patch material for closure of the carotid artery per its FDA cleared Indications for Use.
- The subject must possess the ability to provide written Informed Consent.
- The subject must express an understanding and willingness to fulfill all of the expected requirements of this clinical protocol.
Who cannot join
- Subjects with a known sensitivity to porcine material.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cardio-Thoracic Surgeons, P.C. Trinity
Birmingham, Alabama, 35243
UVA Heart and Vascular Center
Charlottesville, Virginia, 22908
Cardiac Surgery Associates
Indianapolis, Indiana, 46237
St Luke's Hospital
Kansas City, Missouri, 64111
Vascular Surgical Associates P.C.
Marietta, Georgia, 30060
Cardiovascular Surgery Clinic, PLLC
Memphis, Tennessee, 38120
About this study
Official title: CorMatrix® ECM® for Carotid Repair Following Endarterectomy Registry
Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.
Read the detailed description
The objective of this registry is to capture and assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair per its FDA cleared Indications for Use. This registry provides an ongoing post-market surveillance mechanism to document clinical outcomes on the use of the CorMatrix ECM for Carotid Repair.
- Conditions
- Carotid Stenosis
- Being tested
- CorMatrix ECM for Carotid Repair
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorMatrix ECM for Carotid RepairDevice
Subjects must be undergoing carotid endarterectomy with patch angioplasty closure
| Study group | Role | What they receive |
|---|---|---|
| Carotid Endarterectomy Subjects | Subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair Receives: Device: CorMatrix ECM for Carotid Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid Procedure and Device Related Adverse Events to Determine Device Performance
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startApr 2012
- Primary completion31 Dec 2016
- Study completion31 Dec 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 Carotid 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elutia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569594
- Sponsor's protocol ID
- 11-PR-1021
- Status last verified
- Jul 2023
- First submitted
- 30 Mar 2012
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorMatrix® ECM® for Carotid Repair Following Endarterectomy Registry
- ClinicalTrials.gov ID
- NCT01569594
- Acronym / sponsor ID
- 11-PR-1021
- Conditions
- Carotid Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Elutia Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 3 Apr 2012 (estimated)
- Results
- Posted 24 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.
Detailed description
The objective of this registry is to capture and assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair per its FDA cleared Indications for Use. This registry provides an ongoing post-market surveillance mechanism to document clinical outcomes on the use of the CorMatrix ECM for Carotid Repair.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Endarterectomy Subjects | – | Device: CorMatrix ECM for Carotid RepairSubjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 230 subjects may be enrolled from up to ten U.S. clinical sites
Key inclusion criteria (4 listed)
- Subjects must be undergoing carotid endarterectomy with patch angioplasty closure.
- Subject's operative surgeon intends to use CorMatrix ECM as the patch material for closure of the carotid artery per its FDA cleared Indications for Use.
- The subject must possess the ability to provide written Informed Consent.
- The subject must express an understanding and willingness to fulfill all of the expected requirements of this clinical protocol.
Key exclusion criteria (1 listed)
- Subjects with a known sensitivity to porcine material.
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 |
|---|---|---|
| CorMatrix ECM for Carotid RepairSubjects must be undergoing carotid endarterectomy with patch angioplasty closure | Device | Carotid Endarterectomy Subjects |
Primary outcome
Carotid Procedure and Device Related Adverse Events to Determine Device Performance
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 Stenosis, run by Elutia Inc. at 6 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 4 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 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 24 Feb 2020). 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?
Carotid Procedure and Device Related Adverse Events to Determine Device Performance (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2023.