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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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.
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  • 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

Other trials in Germany

Switzerland2 sites

  • Inselspital-Universitätsspital Bern

    Bern

  • Hôpitaux Universitaires de Genève

    Geneva

Other trials in Switzerland

United Kingdom2 sites

  • Spire Leeds Hospital

    Leeds

  • Queen's Hospital of Romford

    Romford

Other trials in United Kingdom

Spain1 site

  • Hospital Universitario de Navarra

    Pamplona

Other trials in Spain

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.

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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Incidence of Parent Vessel Thrombosis

    parent vessel arteries in which thrombosis was documented by an angiogram

    Measured: 6 & 12 Months

  8. Incidence of Parent Vessel Stenosis

    parent vessel arteries in which stenosis was documented by an angiogram,

    Measured: 6 & 12 Months

  9. 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

  10. 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.

  1. First posted14 Apr 2015 (estimated)
  2. Study start1 Jul 2015
  3. Primary completion25 Jun 2019
  4. Study completion25 Jun 2019

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT02415010.

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.

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