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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)

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ClinicalTrials.gov Identifier: NCT02415010
Recruitment Status : Active, not recruiting
First Posted : April 14, 2015
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Cerenovus, Part of DePuy Synthes Products, Inc.

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.

Condition or disease Intervention/treatment
Intracranial Aneurysm Device: Enterprise 2 Vascular Reconstruction Device

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : November 18, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event in subjects with a non-ruptured aneurysm. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Incidence of Successful Aneurysm treatment without retreatment [ Time Frame: 6 Months ]
  2. Incidence of Successful Aneurysm treatment [ Time Frame: 12 months ]
  3. Incidence of Aneurysm Recanalization [ Time Frame: 6 & 12 Months ]
  4. Incidence of Retreatment [ Time Frame: 6 & 12 Months ]
  5. Incidence of New Neurological Deficits [ Time Frame: 30 Days, 6 & 12 Months ]
  6. Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event [ Time Frame: 30 Days and 12 Months ]
  7. Incidence of Parent Vessel Thrombosis [ Time Frame: 6 & 12 Months ]
  8. Incidence of Parent Vessel Stenosis [ Time Frame: 6 & 12 Months ]
  9. Incidence of Stent Movement/Migration [ Time Frame: 6 & 12 Months ]
  10. Frequency of Adverse Events [ Time Frame: 6 & 12 Months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415010


Locations
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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, Germany
Spain
Hospital Universitario de Navarra
Pamplona, Spain
Switzerland
Inselspital-Universitätsspital Bern
Bern, Switzerland
Hôpitaux Universitaires de Genève
Genève, Switzerland
United Kingdom
Spire Leeds Hospital
Leeds, United Kingdom
Queen's Hospital of Romford
Romford, United Kingdom
Sponsors and Collaborators
Cerenovus, Part of DePuy Synthes Products, Inc.
Investigators
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Principal Investigator: J FIEHLER, MD-PhD Universitätsklinikum Hamburg-Eppendorf

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Responsible Party: Cerenovus, Part of DePuy Synthes Products, Inc.
ClinicalTrials.gov Identifier: NCT02415010     History of Changes
Other Study ID Numbers: NV-PMK-1401
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases