Carotid Artery StenosisPERFORMANCENCT04142541
Evaluation of the 3-in-1 Neuroguard IEP System for Carotid Artery Stenosis
A study testing Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System) in people with Carotid Artery Stenosis, run by Contego Medical, Inc. at 6 sites in 2 countries.
Trial summary
The Neuroguard IEP System is a 3-in-1 carotid stent delivery system consisting of an angioplasty balloon, an integrated embolic protection device and a nitinol self-expanding stent loaded over the balloon and constrained by an outer sheath. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 28 Feb 2018to 17 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Male and non-breastfeeding female subjects whose age is ≥18 years.
- Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone.
- Patient is willing to provide written informed consent prior to enrollment in study.
- Females of childbearing potential must have documented negative pregnancy test within 7 days of the Index procedure.
- Patient is either:
- Symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology. Symptomatic is defined as transient ischemia attack (TIA) or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel; or
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- Asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology.
- 7. Patient has a target lesion located at the carotid bifurcation and/or proximal internal carotid artery (ICA).
- 8. Patient has a single de novo or restenotic (post carotid endarterectomy [CEA]) target lesion or severe tandem lesions close enough that can be covered by a single Neuroguard stent.
- 9. Target lesion reference vessel diameter between 4.0 and 7.0 mm. 10. Distal vessel diameter at the site of filter deployment between 4.0 mm and 7.0 mm.
- 11. Sufficient landing zone in the cervical internal carotid artery distal to the lesion to allow for the safe and successful deployment of the primary embolic protection filter (commercially available) and the Neuroguard integrated embolic protection filter.
Who cannot join
- Life expectancy of less than one year.
- Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke in the last 30 days.
- Recently (<30 days) implanted heart valve (either surgically or endovascularly) which is a known source of emboli as confirmed on echocardiogram and anticipated or potential cardiovascular sources of emboli that are not adequately treated with anticoagulants .
- History of or current atrial fibrillation or atrial flutter, including paroxysmal atrial fibrillation.
- Patient has had an acute myocardial infarction within 72 hours prior to index procedure .
- Patient has had or has plans to have any major surgical procedure (i.e. intraabdominal or intrathoracic surgery or any surgery/interventional procedure involving cardiac or vascular system) within 30 days before or after the index procedure.
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- Patient has known severe carotid stenosis or complete occlusion contralateral to the target lesion requiring treatment within 30 days following the index procedure.
- Patient has a modified Rankin Scale (mRS) >2 or has another neurological deficit not due to stroke that may confound the neurological patient assessments (e.g. intracranial tumor).
- Patient has chronic renal insufficiency (serum creatinine ≥2.5 ml/dL), end stage renal disease on hemodialysis, a history of severe hepatic impairment or malignant hypertension.
- Patient has platelet count < 100,000/uL.
- Active bleeding diathesis, hypercoagulable state, or unable to receive blood transfusions.
- Patient has a history of intolerance or contraindication to standard of care study medications, including antiplatelet therapy.
- Patient has a known hypersensitivity to nickel or titanium.
- Sensitivity to heparin or previous incidence of HIT type II.
- Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or uncorrected bleeding disorders.
- Currently enrolled in another interventional device or investigational medication study that has not yet reached the primary endpoint.
- Patient has a total occlusion of the target carotid artery.
- Patient has a previously placed stent in the ipsilateral carotid artery.
- Patient has excessive vascular tortuosity that may preclude the safe introduction of the sheath, guiding catheter, integrated embolic protection device (EPD) or stent.
- Patient has severe calcification of the target lesion that may prevent full expansion of the carotid stent.
- Intraluminal mobile filling defect or fresh thrombus in the target lesion.
- Occlusion or presence of a string sign in the ipsilateral common or internal carotid artery.
- Carotid (intracranial) stenosis located distal to the target lesion that is more severe than the target lesion.
- Known mobile plaque or thrombus in the aortic arch.
- Patient has a type III aortic arch.
- Arteriovenous malformations of the territory of the target carotid artery.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany4 sites
Sankt Gertrauden-Krankenhaus GmbH
Berlin, 10713
Cardiovascular Centre Frankfurt
Frankfurt
Medizinisches Versorgungszentrum
Hamburg, 22527
Universitätsklinikum Leipzig
Leipzig, 04103
Italy2 sites
Maria Cecelia Hospital
Cotignola, 48033
Università Frederico II
Naples
About this study
Official title: Protection Against Emboli During Carotid Artery Stenting Using a 3-in-1delivery System Comprised of a Post-dilation Balloon, Integrated Embolic Filter, and a Novel Carotid Stent (PERFORMANCE 1 Trial)
The Neuroguard IEP System is a 3-in-1 carotid stent delivery system consisting of an angioplasty balloon, an integrated embolic protection device and a nitinol self-expanding stent loaded over the balloon and constrained by an outer sheath. The PERFORMANCE I study is a multi-center, prospective, single arm open label study to evaluate the safety and feasibility of the Neuroguard IEP System for the treatment of carotid artery stenosis. The primary endpoint will be the proportion of patients with Major Adverse Events (MAE) reported within 30 days from the index procedure.
The primary objective of the PERFORMANCE I study is to evaluate the safety and feasibility of the Neuroguard IEP Carotid Stent System when used in patients with clinically significant carotid artery stenosis requiring revascularization.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System)
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System)Device
The Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection is indicated for improving the carotid luminal diameter in patients with clinically significant carotid artery stenosis and for the simultaneous capture and removal of embolic material during angioplasty and stenting.
| Study group | Role | What they receive |
|---|---|---|
| Carotid artery stenting with Neuroguard IEP System | Experimental | To evaluate the safety and feasibility of the Neuroguard IEP System when used in patients with clinically significant carotid artery stenosis requiring revascularization. Receives: Device: Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Event (MAE)
Death, stroke, myocardial infarction (MI) within 30 days of the index procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start28 Feb 2018
- Primary completion18 Mar 2019
- Study completion17 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contego Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alberto Cremonesi, MD, Principal investigator, Maria Cecelia Hospital Cotignola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142541
- Sponsor's protocol ID
- CSP1263
- Acronym
- PERFORMANCE
- Status last verified
- Nov 2022
- First submitted
- 26 Jul 2019
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langhoff R, Petrov I, Kedev S, Milosevic Z, Schmidt A, Scheinert D, Schofer J, Sievert H, Sedgewick G, Saylors E, Sachar R, Cremonesi A, Micari A. PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device. Catheter Cardiovasc Interv. 2022 Nov;100(6):1090-1099. doi: 10.1002/ccd.30410. Epub 2022 Oct 13.
PubMed 36229946
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection Against Emboli During Carotid Artery Stenting Using a 3-in-1delivery System Comprised of a Post-dilation Balloon, Integrated Embolic Filter, and a Novel Carotid Stent (PERFORMANCE 1 Trial)
- ClinicalTrials.gov ID
- NCT04142541
- Acronym / sponsor ID
- PERFORMANCE / CSP1263
- Conditions
- Carotid Artery Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Contego Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Neuroguard IEP System is a 3-in-1 carotid stent delivery system consisting of an angioplasty balloon, an integrated embolic protection device and a nitinol self-expanding stent loaded over the balloon and constrained by an outer sheath. The PERFORMANCE I study is a multi-center, prospective, single arm open label study to evaluate the safety and feasibility of the Neuroguard IEP System for the treatment of carotid artery stenosis. The primary endpoint will be the proportion of patients with Major Adverse Events (MAE) reported within 30 days from the index procedure.
The primary objective of the PERFORMANCE I study is to evaluate the safety and feasibility of the Neuroguard IEP Carotid Stent System when used in patients with clinically significant carotid artery stenosis requiring revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid artery stenting with Neuroguard IEP System | Experimental | Device: Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System)To evaluate the safety and feasibility of the Neuroguard IEP System when used in patients with clinically significant carotid artery stenosis requiring revascularization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and non-breastfeeding female subjects whose age is ≥18 years.
- Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone.
- Patient is willing to provide written informed consent prior to enrollment in study.
- Females of childbearing potential must have documented negative pregnancy test within 7 days of the Index procedure.
- Patient is either:
Key exclusion criteria (26 listed)
- Life expectancy of less than one year.
- Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke in the last 30 days.
- Recently (<30 days) implanted heart valve (either surgically or endovascularly) which is a known source of emboli as confirmed on echocardiogram and anticipated or potential cardiovascular sources of emboli that are not adequately treated with anticoagulants .
- History of or current atrial fibrillation or atrial flutter, including paroxysmal atrial fibrillation.
- Patient has had an acute myocardial infarction within 72 hours prior to index 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 |
|---|---|---|
| Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System)The Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection is indicated for improving the carotid luminal diameter in patients with clinically significant carotid artery stenosis and for the simultaneous capture and removal of embolic material during angioplasty and stenting. | Device | Carotid artery stenting with Neuroguard IEP System |
Primary outcome
Major Adverse Event (MAE)
Time frame: 30 days
Death, stroke, myocardial infarction (MI) within 30 days of the index procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Background: PubMed 36229946Langhoff R, Petrov I, Kedev S, Milosevic Z, Schmidt A, Scheinert D, Schofer J, Sievert H, Sedgewick G, Saylors E, Sachar R, Cremonesi A, Micari A. PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device. Catheter Cardiovasc Interv. 2022 Nov;100(6):1090-1099. doi: 10.1002/ccd.30410. Epub 2022 Oct 13.
- Individual participant dataSharing planned: No
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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.
Alberto Cremonesi, MD principal investigator
Maria Cecelia Hospital Cotignola
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System) in people with Carotid Artery Stenosis, run by Contego Medical, Inc. at 6 sites in 2 countries.
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 11 inclusion and 26 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 Nov 2022. 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 Germany, Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Major Adverse Event (MAE) (time frame: 30 days). 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 NCT04142541, which also lists 1 linked publication.
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 Nov 2022.