Post-Market Clinical Follow-Up Study to Confirm Clinical... | NCT02415010

Studies
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

Sponsor

Cerenovus, Part of DePuy Synthes Products, Inc.

Status

Terminated

Last Update Posted

Dec 12, 2019Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Intracranial Aneurysm

Interventions

Enterprise 2 Vascular Reconstruction Device

Countries

Germany
Spain
Switzerland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2015Actual

Primary Completion Date

Jun 25, 2019Actual

Completion Date

Jun 25, 2019Actual

First Submitted Date

Apr 8, 2015

First Submission Date that Met QC Criteria

Apr 8, 2015

First Posted Date

Apr 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2019

Last Update Posted Date

Dec 12, 2019Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Name	Type	Description	Arm Group Labels	Other Names
Enterprise 2 Vascular Reconstruction Device	Device	Stenting Assisted coiling procedure

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Helios Klinikum Berlin		Berlin			Germany
Universitätslklinikum der Ruhr Universität Bochum

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases