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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 : Terminated
First Posted : April 14, 2015
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Cerenovus, Part of DePuy Synthes Products, Inc.

Tracking Information
First Submitted Date April 8, 2015
First Posted Date April 14, 2015
Last Update Posted Date December 12, 2019
Actual Study Start Date July 1, 2015
Actual Primary Completion Date June 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2019)
Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event in subjects with a non-ruptured aneurysm. [ Time Frame: 6 months ]
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
Original Primary Outcome Measures
 (submitted: April 8, 2015)
Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event in subjects with a non-ruptured aneurysm. [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures
 (submitted: December 10, 2019)
  • Incidence of Successful Aneurysm treatment without retreatment [ Time Frame: 6 Months ]
    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.
  • Incidence of Successful Aneurysm treatment [ Time Frame: 12 months ]
    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.
  • Incidence of Aneurysm Recanalization [ Time Frame: 6 & 12 Months ]
    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.
  • Incidence of Retreatment [ Time Frame: 6 & 12 Months ]
    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.
  • Incidence of New Neurological Deficits [ Time Frame: 30 Days, 6 & 12 Months ]
    subjects who have an increase in mRS greater than 2 from baseline related to stroke or death
  • Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event [ Time Frame: 30 Days and 12 Months ]
    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
  • Incidence of Parent Vessel Thrombosis [ Time Frame: 6 & 12 Months ]
    parent vessel arteries in which thrombosis was documented by an angiogram
  • Incidence of Parent Vessel Stenosis [ Time Frame: 6 & 12 Months ]
    parent vessel arteries in which stenosis was documented by an angiogram,
  • Incidence of Stent Movement/Migration [ Time Frame: 6 & 12 Months ]
    parent artery in which CODMAN Enterprise® 2 migration was documented from the index procedure until completion of the follow-up visit.
  • Frequency of Adverse Events [ Time Frame: 6 & 12 Months ]
    Occurence of any AE related to device/procedure/disease
Original Secondary Outcome Measures
 (submitted: April 8, 2015)
  • Incidence of Successful Aneurysm treatment without retreatment [ Time Frame: 6 Months ]
  • Incidence of Successful Aneurysm treatment [ Time Frame: 12 months ]
  • Incidence of Aneurysm Recanalization [ Time Frame: 6 & 12 Months ]
  • Incidence of Retreatment [ Time Frame: 6 & 12 Months ]
  • Incidence of New Neurological Deficits [ Time Frame: 30 Days, 6 & 12 Months ]
  • Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event [ Time Frame: 30 Days and 12 Months ]
  • Incidence of Parent Vessel Thrombosis [ Time Frame: 6 & 12 Months ]
  • Incidence of Parent Vessel Stenosis [ Time Frame: 6 & 12 Months ]
  • Incidence of Stent Movement/Migration [ Time Frame: 6 & 12 Months ]
  • Frequency of Adverse Events [ Time Frame: 6 & 12 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Intracranial Aneurysm
Intervention Device: Enterprise 2 Vascular Reconstruction Device
Stenting Assisted coiling procedure
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: December 10, 2019)
26
Original Estimated Enrollment
 (submitted: April 8, 2015)
50
Actual Study Completion Date June 25, 2019
Actual Primary Completion Date June 25, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Spain,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02415010
Other Study ID Numbers NV-PMK-1401
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Cerenovus, Part of DePuy Synthes Products, Inc.
Study Sponsor Cerenovus, Part of DePuy Synthes Products, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: J FIEHLER, MD-PhD Universitätsklinikum Hamburg-Eppendorf
PRS Account Cerenovus, Part of DePuy Synthes Products, Inc.
Verification Date December 2019