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

Intracranial Aneurysm Clinical Trial

— SUNRISE-2  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02415010
• Other study ID #: NV-PMK-1401
• Status: Terminated
• Start date: July 1, 2015
• Est. completion date: June 25, 2019

Study information

• Verified date: December 2019
• Source: Cerenovus, Part of DePuy Synthes Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: June 25, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Enterprise 2 Vascular Reconstruction Device
Stenting Assisted coiling procedure

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cerenovus, Part of DePuy Synthes Products, Inc.

Countries where clinical trial is conducted

Germany,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of Parent Vessel Thrombosis	parent vessel arteries in which thrombosis was documented by an angiogram	6 & 12 Months
Secondary	Incidence of Parent Vessel Stenosis	parent vessel arteries in which stenosis was documented by an angiogram,	6 & 12 Months
Secondary	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
Secondary	Frequency of Adverse Events	Occurence of any AE related to device/procedure/disease	6 & 12 Months