Intracranial AneurysmSUNRISE-2NCT02415010
Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise® 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms
An observational study of Intracranial Aneurysm, run by Cerenovus, Part of DePuy Synthes Products, Inc. at 10 sites in 4 countries.
Trial summary
The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Enterprise 2 Vascular Reconstruction Device
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 1 Jul 2015to 25 Jun 2019
- Phase
- Observational
- 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
Study population: Subjects with both ruptured and non-ruptured aneurysms will be enrolled into the study, with a parent vessel diameter of ≥ 2.0 mm and ≤ 4 mm
Who may be able to join
- Subject ≥ 18 years old.
- Subjects with non-ruptured or ruptured intracranial aneurysm that is referred for endovascular treatment.
- Parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm.
- Subject understands the nature of the procedure and provides voluntary written informed consent in accordance with the requirements of this study protocol.
- Subject is willing to participate in the telephone follow-ups and to return to the investigational site for the post-procedure follow-up evaluations.
Who cannot join
- Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e.: severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy).
- Mycotic or traumatic aneurysm.
- Arteriovenous malformation (AVM) in the territory of the target aneurysm.
- Two or more aneurysms (>2mm) in associated distribution.
- Hunt and Hess Scale (HHS) of IV or V at inclusion for subject with ruptured aneurysms.
- Life expectancy of less than 6 months as determined by the treating physician.
Show all 15Show fewer
- A planned staged procedure (i.e. a procedure where entire treatment with the devices (e.g. coils/stents) is completed over separate sessions).
- Previous neuro-interventional or neuro-surgical procedure of any kind within 30 days prior to the study procedure.
- Intracranial mass (tumor, abscess, or other infection), or undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.
- Unsuitable for the antithrombotic and/or anticoagulant therapies
- Serum creatinine level > 2.5 mg/dl within 7 days prior to index procedure
- Known hypersensitivity or allergies to cobalt, nitinol metal, nickel, or sensitivity to contrast media,
- Evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.
- Uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
- Subject is pregnant
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Germany5 sites
Helios Klinikum Berlin
Berlin
Universitätslklinikum der Ruhr Universität Bochum
Bochum
Universitätsklinikum Hamburg Eppendorf
Eppendorf
Asklepios Klinik Atona
Hamburg
Universitätsklinikum Schl.-Holst. Campus Lübeck
Lübeck
Switzerland2 sites
Inselspital-Universitätsspital Bern
Bern
Hôpitaux Universitaires de Genève
Geneva
United Kingdom2 sites
Spire Leeds Hospital
Leeds
Queen's Hospital of Romford
Romford
About this study
Official title: A Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise® 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms
The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured intracranial aneurysms.
- Conditions
- Intracranial Aneurysm
- Being tested
- Enterprise 2 Vascular Reconstruction Device
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enterprise 2 Vascular Reconstruction DeviceDevice
Stenting Assisted coiling procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event in subjects with a non-ruptured aneurysm.
any a new neurological event, which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the National Institute of Health Stroke Scale (NIHSS), as compared to baseline and persists for greater than 24 hours
Measured: 6 months
Secondary outcomes (10)
Incidence of Successful Aneurysm treatment without retreatment
aneurysms categorized as adequate occlusion (i.e., scored as complete [100%] or near completely occluded [90-99%]), without additional procedures for treatment of the aneurysm since the index procedure.
Measured: 6 Months
Incidence of Successful Aneurysm treatment
aneurysms categorized as adequate occlusion (i.e., scored as complete [100%] or near completely occluded [90-99%]), without additional procedures for treatment of the aneurysm since the index procedure.
Measured: 12 months
Incidence of Aneurysm Recanalization
any increase in aneurysm filling, compared to the previous study-specified angiographic assessment, resulting in a change in (i.e., worsening of) the 3-point scale.
Measured: 6 & 12 Months
Incidence of Retreatment
aneurysms with any additional treatment of the target aneurysm after the index procedure (regardless of whether retreatment is by surgery or endovascular treatment) due to recanalization, rupture, bleeding or staged procedure.
Measured: 6 & 12 Months
Incidence of New Neurological Deficits
subjects who have an increase in mRS greater than 2 from baseline related to stroke or death
Measured: 30 Days, 6 & 12 Months
Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event
any a new neurological event, which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the National Institute of Health Stroke Scale (NIHSS), as compared to baseline and persists for greater than 24 hours
Measured: 30 Days and 12 Months
Incidence of Parent Vessel Thrombosis
parent vessel arteries in which thrombosis was documented by an angiogram
Measured: 6 & 12 Months
Incidence of Parent Vessel Stenosis
parent vessel arteries in which stenosis was documented by an angiogram,
Measured: 6 & 12 Months
Incidence of Stent Movement/Migration
parent artery in which CODMAN Enterprise® 2 migration was documented from the index procedure until completion of the follow-up visit.
Measured: 6 & 12 Months
Frequency of Adverse Events
Occurence of any AE related to device/procedure/disease
Measured: 6 & 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study start1 Jul 2015
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies 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
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J FIEHLER, MD-PhD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415010
- Sponsor's protocol ID
- NV-PMK-1401
- Acronym
- SUNRISE-2
- Status last verified
- Dec 2019
- First submitted
- 8 Apr 2015
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise® 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT02415010
- Acronym / sponsor ID
- SUNRISE-2 / NV-PMK-1401
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 14 Apr 2015 (estimated)
- 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 objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured intracranial aneurysms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with both ruptured and non-ruptured aneurysms will be enrolled into the study, with a parent vessel diameter of ≥ 2.0 mm and ≤ 4 mm
Key inclusion criteria (5 listed)
- Subject ≥ 18 years old.
- Subjects with non-ruptured or ruptured intracranial aneurysm that is referred for endovascular treatment.
- Parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm.
- Subject understands the nature of the procedure and provides voluntary written informed consent in accordance with the requirements of this study protocol.
- Subject is willing to participate in the telephone follow-ups and to return to the investigational site for the post-procedure follow-up evaluations.
Key exclusion criteria (15 listed)
- Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e.: severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy).
- Mycotic or traumatic aneurysm.
- Arteriovenous malformation (AVM) in the territory of the target aneurysm.
- Two or more aneurysms (>2mm) in associated distribution.
- Hunt and Hess Scale (HHS) of IV or V at inclusion for subject with ruptured aneurysms.
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 |
|---|---|---|
| Enterprise 2 Vascular Reconstruction DeviceStenting Assisted coiling procedure | Device | – |
Primary outcome
Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event in subjects with a non-ruptured aneurysm.
Time frame: 6 months
any a new neurological event, which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the National Institute of Health Stroke Scale (NIHSS), as compared to baseline and persists for greater than 24 hours
10 secondary outcomes
Incidence of Successful Aneurysm treatment without retreatment
Time frame: 6 Months
Incidence of Successful Aneurysm treatment
Time frame: 12 months
Incidence of Aneurysm Recanalization
Time frame: 6 & 12 Months
Incidence of Retreatment
Time frame: 6 & 12 Months
Incidence of New Neurological Deficits
Time frame: 30 Days, 6 & 12 Months
Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event
Time frame: 30 Days and 12 Months
Incidence of Parent Vessel Thrombosis
Time frame: 6 & 12 Months
Incidence of Parent Vessel Stenosis
Time frame: 6 & 12 Months
Incidence of Stent Movement/Migration
Time frame: 6 & 12 Months
Frequency of Adverse Events
Time frame: 6 & 12 Months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
Related trials for Intracranial Aneurysm
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
RecruitingObservational study
Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm
Intracranial Sacciform Aneurysm
Not yet recruiting
The NUVASCULAR HARBOR Occlusion Device EU Study
Intracranial Arterial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
Active, not recruitingPhase 2
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
Cerebral Aneurysm
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.
J FIEHLER, MD-PhD principal investigator
Universitätsklinikum Hamburg-Eppendorf
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Cerenovus, Part of DePuy Synthes Products, Inc. at 10 sites in 4 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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 12 Dec 2019. 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, Switzerland, United Kingdom, Spain. 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 was stopped early. Results are not available in the source record.
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?
Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event in subjects with a non-ruptured aneurysm. (time frame: 6 months). 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 12 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.