Carotid Artery DiseasesWISENCT01783639
Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting
A study testing Carotid Artery Stent in people with Carotid Artery Diseases and Stroke, run by Gardia Medical at 10 sites in 3 countries.
Trial summary
The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with embolic protection studies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Diseases, Stroke
- What is being tested?
- Carotid Artery Stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Feb 2013to Apr 2015
- Phase
- Interventional
- 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
Who may be able to join
- 18 years of age
- Anticipated patient life expectancy of at least 1 year
- Patient or authorized representative, signed a written Informed Consent form
- Patient is willing to comply with the protocol requirements
- Candidate for catheter-based therapy of a single stenosis located in the internal carotid artery (ICA) or the carotid bifurcation, suitable for treatment with a single FDA-approved stent with a carotid use indication
- Reference vessel diameter for intended filter location between 3.5mm and 6.0mm
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- An adequate "landing zone" of at least 30mm
- Patients with severe symptomatic or asymptomatic carotid artery stenosis, to be ≥ 50% for symptomatic patients OR ≥ 80% for asymptomatic patients
- At least one high surgical risk criteria, either anatomical or co-morbid risk factors, as listed below:
- Category I - Anatomical high risk factors
- Recurrent stenosis after endarterectomy
- Previous radical neck surgery or radiation therapy to the neck
- High cervical ICA lesions or CCA lesions at or above C2 or below the clavicle
- Spinal immobility of the neck
- Tracheostomy or tracheal stoma
- Any laryngeal nerve palsy and bilateral carotid artery stenosis
- Category II - Co-morbid risk factors
- Contralateral carotid occlusion
- Unstable angina (Canadian Cardiovascular Society class III/IV)
- Congestive Heart Failure (New York Heart Association functional class III/IV) and/or known severe left ventricular dysfunction LVEF<30%
- Requires coronary artery bypass surgery, cardiac valve surgery, major vascular surgery, or abdominal aortic aneurysm repair 31-60 days post carotid stent procedure
- Recent MI (>72 hr and <4 weeks)
- Severe pulmonary disease with FEV1 of <30%
- CAD in ≥2 unrevascularized vessels with stenosis ≥70%
- Age ≥75 years
- Uncontrolled diabetes - Female patient with no child bearing potential or has negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study
Who cannot join
- Total occlusion or near-occlusion of the target vessel
- Severe lesion calcification
- Presence of an alternate source of emboli
- Presence of a filling defect, or angiographically visible thrombus, at target site
- A greater than 50% CCA lesion proximal to the target or a distal (intracranial) lesion more severe than the target lesion
- Evolving, acute or recent stroke within the last 30 days
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- Major stroke with a residual neurological deficit that would confound neurologic assessment
- Vertebrobasilar insufficiency symptoms only
- Major operation 30 days before or after the index procedure
- Ipsilateral intracranial stenosis that requires treatment
- Any pre-existing stent in ipsilateral carotid artery, or placement of a stent in contralateral carotid within 30 days of the index procedure
- History of intracranial hemorrhage within 12 months
- Any condition that precludes proper angiographic assessment or prevents femoral arterial access
- Uncontrolled hypertension
- Contraindication to heparin and bivalirudin, aspirin, thienopyridines
- Known sensitivity to radiographic contrast media which cannot be controlled with pre-medication
- History or current indication of bleeding diathesis or coagulopathy
- Chronic renal insufficiency
- Carotid artery dissection or aortic arch anatomical anomalies
- Dementia or a neurological illness
- Patient is enrolled in another drug or device study protocol that has not reached its primary endpoint
- Severe pulmonary hypertension
- Intra-cranial pathology (e.g., tumor, AVM. aneurysm, etc) that would make study participation inappropriate or confound neurologic assessment
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Germany7 sites
Universitaets Herzzentrum
Bad Krozingen, 79189
Ihre-Radiologen.de
Berlin, 13347
Klinikum Dortmund GmbH
Dortmund, 44137
CardioVascular Center Frankfurt
Frankfurt, 60389
Hamburg University Cardiovascular Center
Hamburg, 22527
Herzzentrum and Park-Krankenhaus
Leipzig, 04289
Städtisches Klinikum München GmbH Klinikum Neuperlach
Munich, 87137
Italy2 sites
Villa Maria Cecilia Hospital
Cotignola, 48010
Mirano Hospital
Mirano, 30035
Belgium1 site
AZ Sint Blasius Hospital, Department of Vascular Surgery
Dendermonde, 9200
About this study
Official title: The WISE Study is a Pivotal Study Evaluating the Safety and Performance of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting
The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with embolic protection studies
Read the detailed description
Patient registry procedures include:
- Clinical Events Committee (CEC); responsibility for validating all reported primary safety outcomes
- Data Safety Monitoring Board (DSMB); to review and evaluate safety data including serious adverse events
- 100% data monitoring; to compare data entered into the registry
- Source data verification; to assess the accuracy, completeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms).
- Standard Operating Procedures; to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis and reporting for adverse events.
- Sample size assessment to specify the number of participants and follow up duration.
- Data Management Plan; to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
- Statistical analysis plan; describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
- Conditions
- Carotid Artery Diseases, Stroke
- Being tested
- Carotid Artery Stent
- Keywords
- Carotid, Carotid artery stenting, Stent, Embolic protection, Atherosclerotic Disease
- Medical subject headings
- Carotid Artery Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Artery StentProcedure or surgery
Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Device: WIRION™ Embolic Protection System
Interventions: Carotid Artery Stent Receives: Procedure: Carotid Artery Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction.
Each participant will be followed for 30 days of procedure during which the number of major cardiac and cerebral adverse events (Stroke, Death and Myocardial Infraction) will be counted to evaluate the device safety.
Measured: Within 30 Days of procedure
Secondary outcomes (6)
The Rate of Device Success
Defined as a successful delivery, deployment and retrieval of WIRION™ without any complications
Measured: Participants will be followed for the duration of the procedure, an expected average of 35 minutes
The Rate of Clinical Success
Defined as freedom from procedure related serious adverse events
Measured: Participants will be followed for the duration of the procedure, an expected average of 35 minutes
The Rate of Access Site Complications
Measured: Within 30 Days of procedure
Neurological Events Occurring Within 30 Days Post Procedure,Including Strokes and Transient Ischemic Attacks
Measured: Within 30 Days of procedure
Angiographic Success
Successful completion of the protected stent procedure without angiographic complications
Measured: Participants will be followed for the duration of the procedure, an expected average of 35 minutes
Procedural Success
Defined as both device and angiographic success
Measured: Participants will be followed for the duration of the procedure, an expected average of 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseasesStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gardia Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dierk Scheinert, MD, Principal investigator, Herzzentrum Leipzig GmbH and Park-Krankenhaus LeipzigHorst Sievert, MD, Principal investigator, Cardio Vascular Center FrankfurtStefan Rohde, MD, Principal investigator, Radiologische Klinik, Klinikum Dortmund GmbHJoachim Schofer, MD, Principal investigator, Universitäres Herz- und Gefäßzentrum HamburgHarald Mudra, MD, Principal investigator, Städtisches Klinikum München GmbHMarc Bosiers, MD, Principal investigator, AZ St-Blasius, DendermondeThomas Zeller, MD, Principal investigator, Universitaets Herzzentrum, Bad-KrozingenAlberto Cremonesi, MD, Principal investigator, Villa Maria Cecilia, Contignola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783639
- Sponsor's protocol ID
- WIRION™ Pivotal Study (WISE)
- Other IDs
- WIRION Study Europe (WISE)
- Acronym
- WISE
- Status last verified
- Jun 2017
- First submitted
- 13 Jan 2013
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Scheinert D, Reimers B, Cremonesi A, Schmidt A, Sievert H, Rohde S, Schofer J, Mudra HG, Bosiers M, Zeller T, Pacchioni A, Rosenschein U; WISE (Wirion Study Europe) Pivotal Trial Investigators. Independent Modular Filter for Embolic Protection in Carotid Stenting. Circ Cardiovasc Interv. 2017 Mar;10(3):e004244. doi: 10.1161/CIRCINTERVENTIONS.116.004244.
PubMed 28283511
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WISE Study is a Pivotal Study Evaluating the Safety and Performance of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting
- ClinicalTrials.gov ID
- NCT01783639
- Acronym / sponsor ID
- WISE / WIRION™ Pivotal Study (WISE)
- Conditions
- Carotid Artery Diseases, Stroke
- Keywords
- Carotid, Carotid artery stenting, Stent, Embolic protection, Atherosclerotic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gardia MedicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Posted 22 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with embolic protection studies
Detailed description
Patient registry procedures include:
- Clinical Events Committee (CEC); responsibility for validating all reported primary safety outcomes
- Data Safety Monitoring Board (DSMB); to review and evaluate safety data including serious adverse events
- 100% data monitoring; to compare data entered into the registry
- Source data verification; to assess the accuracy, completeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms).
- Standard Operating Procedures; to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis and reporting for adverse events.
- Sample size assessment to specify the number of participants and follow up duration.
- Data Management Plan; to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
- Statistical analysis plan; describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: Carotid Artery StentDevice: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 18 years of age
- Anticipated patient life expectancy of at least 1 year
- Patient or authorized representative, signed a written Informed Consent form
- Patient is willing to comply with the protocol requirements
- Candidate for catheter-based therapy of a single stenosis located in the internal carotid artery (ICA) or the carotid bifurcation, suitable for treatment with a single FDA-approved stent with a carotid use indication
Key exclusion criteria (23 listed)
- Total occlusion or near-occlusion of the target vessel
- Severe lesion calcification
- Presence of an alternate source of emboli
- Presence of a filling defect, or angiographically visible thrombus, at target site
- A greater than 50% CCA lesion proximal to the target or a distal (intracranial) lesion more severe than the target lesion
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 |
|---|---|---|
| Carotid Artery StentAssessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices | Procedure or surgery | Arm 1 |
Primary outcome
The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction.
Time frame: Within 30 Days of procedure
Each participant will be followed for 30 days of procedure during which the number of major cardiac and cerebral adverse events (Stroke, Death and Myocardial Infraction) will be counted to evaluate the device safety.
6 secondary outcomes
The Rate of Device Success
Time frame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes
The Rate of Clinical Success
Time frame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes
The Rate of Access Site Complications
Time frame: Within 30 Days of procedure
Neurological Events Occurring Within 30 Days Post Procedure,Including Strokes and Transient Ischemic Attacks
Time frame: Within 30 Days of procedure
Angiographic Success
Time frame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes
Procedural Success
Time frame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28283511Scheinert D, Reimers B, Cremonesi A, Schmidt A, Sievert H, Rohde S, Schofer J, Mudra HG, Bosiers M, Zeller T, Pacchioni A, Rosenschein U; WISE (Wirion Study Europe) Pivotal Trial Investigators. Independent Modular Filter for Embolic Protection in Carotid Stenting. Circ Cardiovasc Interv. 2017 Mar;10(3):e004244. doi: 10.1161/CIRCINTERVENTIONS.116.004244.
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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.
Dierk Scheinert, MD principal investigator
Herzzentrum Leipzig GmbH and Park-Krankenhaus Leipzig
Horst Sievert, MD principal investigator
Cardio Vascular Center Frankfurt
Stefan Rohde, MD principal investigator
Radiologische Klinik, Klinikum Dortmund GmbH
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid Artery Stent in people with Carotid Artery Diseases and Stroke, run by Gardia Medical at 10 sites in 3 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 26 inclusion and 23 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 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Italy, Belgium. 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 22 Jul 2015). 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?
The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction. (time frame: Within 30 Days of 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 NCT01783639, 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 7 Aug 2017.