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 (SUNRISE-2)

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.

Study Overview

• Status: Terminated
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Enterprise 2 Vascular Reconstruction Device

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Helios Klinikum Berlin
  • Bochum, Germany
    • Universitätslklinikum der Ruhr Universität Bochum
  • Eppendorf, Germany
    • Universitatsklinikum Hamburg Eppendorf
  • Hamburg, Germany
    • Asklepios Klinik Atona
  • Lübeck, Germany
    • Universitätsklinikum Schl.-Holst. Campus Lübeck
• Spain
  • Pamplona, Spain
    • Hospital Universitario de Navarra
• Switzerland
  • Bern, Switzerland
    • Inselspital-Universitätsspital Bern
  • Genève, Switzerland
    • Hôpitaux Universitaires de Genève
• United Kingdom
  • Leeds, United Kingdom
    • Spire Leeds Hospital
  • Romford, United Kingdom
    • Queen's Hospital of Romford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

Inclusion Criteria:

1. Subject ≥ 18 years old.
2. Subjects with non-ruptured or ruptured intracranial aneurysm that is referred for endovascular treatment.
3. Parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm.
4. Subject understands the nature of the procedure and provides voluntary written informed consent in accordance with the requirements of this study protocol.
5. Subject is willing to participate in the telephone follow-ups and to return to the investigational site for the post-procedure follow-up evaluations.

Exclusion Criteria:

1. 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).
2. Mycotic or traumatic aneurysm.
3. Arteriovenous malformation (AVM) in the territory of the target aneurysm.
4. Two or more aneurysms (>2mm) in associated distribution.
5. Hunt and Hess Scale (HHS) of IV or V at inclusion for subject with ruptured aneurysms.
6. Life expectancy of less than 6 months as determined by the treating physician.
7. A planned staged procedure (i.e. a procedure where entire treatment with the devices (e.g. coils/stents) is completed over separate sessions).
8. Previous neuro-interventional or neuro-surgical procedure of any kind within 30 days prior to the study procedure.
9. Intracranial mass (tumor, abscess, or other infection), or undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.
10. Unsuitable for the antithrombotic and/or anticoagulant therapies
11. Serum creatinine level > 2.5 mg/dl within 7 days prior to index procedure
12. Known hypersensitivity or allergies to cobalt, nitinol metal, nickel, or sensitivity to contrast media,
13. Evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.
14. Uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
15. Subject is pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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	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	30 Days and 12 Months
Incidence of Parent Vessel Thrombosis	parent vessel arteries in which thrombosis was documented by an angiogram	6 & 12 Months
Incidence of Parent Vessel Stenosis	parent vessel arteries in which stenosis was documented by an angiogram,	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.	6 & 12 Months
Frequency of Adverse Events	Occurence of any AE related to device/procedure/disease	6 & 12 Months

Collaborators and Investigators

• Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
• Investigators: Principal Investigator: J FIEHLER, MD-PhD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): June 25, 2019
• Study Completion (Actual): June 25, 2019

Study Registration Dates

• First Submitted: April 8, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: NV-PMK-1401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No