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

NCT02415010 | Terminated

• 1 other identifier: NV-PMK-1401
• Study Type: observational
• Target: 26
• Locations: 4 countries
• Sites: 10

Brief 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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (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

  6 months

Secondary Outcomes (10)

• Incidence of Successful Aneurysm treatment without retreatment

  6 Months

• Incidence of Successful Aneurysm treatment

  12 months

• Incidence of Aneurysm Recanalization

  6 & 12 Months

• Incidence of Retreatment

  6 & 12 Months

• Incidence of New Neurological Deficits

  30 Days, 6 & 12 Months

Interventions

Enterprise 2 Vascular Reconstruction Device DEVICE

Stenting Assisted coiling procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Life expectancy of less than 6 months as determined by the treating physician.
• 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

Sponsors & Collaborators

• Cerenovus, Part of DePuy Synthes Products, Inc.: lead

Study Sites (10)

Helios Klinikum Berlin

Berlin, Germany

Location

Universitätslklinikum der Ruhr Universität Bochum

Bochum, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Eppendorf, Germany

Location

Asklepios Klinik Atona

Hamburg, Germany

Location

Universitätsklinikum Schl.-Holst. Campus Lübeck

Lübeck, Germany

Location

Hospital Universitario de Navarra

Pamplona, Spain

Location

Inselspital-Universitätsspital Bern

Bern, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Spire Leeds Hospital

Leeds, United Kingdom

Location

Queen's Hospital of Romford

Romford, United Kingdom

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• J FIEHLER, MD-PhD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 14, 2015
• Study Start: July 1, 2015
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

ES (1); DE (5); GB (2); CH (2)