Intracranial AneurysmSUNRISENCT00486226
The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
An observational study of Intracranial Aneurysm, run by Codman & Shurtleff at 1 site in Belgium.
Trial summary
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Vascular Reconstruction Device
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2007to 1 Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering of an intracranial aneurysm and necessitating an endovascular treatment. Patients who meet all of the general inclusion criteria and none of the exclusion criteria and who agree to voluntarily sign a informed consent form will be enrolled into the study.
Who may be able to join
- The subject must be >= 18 years of age and less than 80 years.
- Diagnosis of a ruptured (Hunt and Hess Grade I - III) or unruptured intracranial aneurysm at the time of the treatment
- Subject (or his/her legal representative) provides written informed consent for the use of his/her peri-procedural and follow-up data
Who cannot join
- Diagnosis of Hunt and Hess Grade IV or V subarachnoid hemorrhage at the time of the treatment
- Severe co-morbidity associated with a life-expectancy of less than six months
- Poor neurological status at baseline
- Known allergies to Nitinol metal
- Known allergies to aspirin, heparin, ticlopidine, or clopidogrel or unable or unwilling to tolerate therapy
- Participation in an investigational drug or another device study is only allowed after written approval of the coordinating investigator or Cordis Medical Monitor.
Show all 9Show fewer
- Implantation of an intracranial stent associated with the symptomatic distribution within 12 weeks prior to the index procedure
- Implantation of carotid stent associated with the symptomatic distribution within 12 weeks prior to the index procedure
- Atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The SUNRISE Registry - A Multicenter Post-Market Surveillance With the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial aneurysms.
Read the detailed description
The data will be collected in consecutive subjects treated with the commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CORDIS ENTERPRISE™ VRD during the index procedure. While only limited inclusion or exclusion criteria are specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up up to 6 months. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the VRD placement, coiling procedure, application of antiplatelet medication and any other medical therapy to be provided according to local usual practice.
- Conditions
- Intracranial Aneurysm
- Being tested
- Vascular Reconstruction Device
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular Reconstruction DeviceDevice
Also called ENTERPRISE, Codman ENTERPRISE, Codman VRD
CORDIS ENTERPRISE™ VRD
| Study group | Role | What they receive |
|---|---|---|
| 1 Endovascular | All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device. Receives: Device: Vascular Reconstruction Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)
Successful intracranial VRD placement is defined as stable VRD placement with complete coverage of the aneurysm neck and parent artery patency. Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
Measured: Intra-procedure
Secondary outcomes (3)
Device or Procedure Related Adverse Events (AEs)
Incidence of device or procedure related adverse events during the index procedure and till discharge
Measured: index procedure to discharge; an average of 3.8 days
Satisfactory Coil Mass Position
Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
Measured: 6 months
Aneurysm Occlusion
Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)
Measured: post procedure to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study start1 Jun 2007
- Primary completion1 Dec 2012
- Study completion1 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codman & Shurtleff
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bendszus Martin, MD, Principal investigator, Wuerzburg University HospitalBoris Lubicz, MD, Principal investigator, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486226
- Sponsor's protocol ID
- EN07-01
- Acronym
- SUNRISE
- Status last verified
- Dec 2018
- First submitted
- 13 Jun 2007
- Last updated
- 12 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SUNRISE Registry - A Multicenter Post-Market Surveillance With the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System
- ClinicalTrials.gov ID
- NCT00486226
- Acronym / sponsor ID
- SUNRISE / EN07-01
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Codman & ShurtleffIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2007 (actual)
- Primary completion
- 1 Dec 2012 (actual)
- Study completion
- 1 Dec 2013 (actual)
- First posted
- 14 Jun 2007 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial aneurysms.
Detailed description
The data will be collected in consecutive subjects treated with the commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CORDIS ENTERPRISE™ VRD during the index procedure. While only limited inclusion or exclusion criteria are specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up up to 6 months. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the VRD placement, coiling procedure, application of antiplatelet medication and any other medical therapy to be provided according to local usual practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 Endovascular | – | Device: Vascular Reconstruction DeviceAll patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering of an intracranial aneurysm and necessitating an endovascular treatment. Patients who meet all of the general inclusion criteria and none of the exclusion criteria and who agree to voluntarily sign a informed consent form will be enrolled into the study.
Key inclusion criteria (3 listed)
- The subject must be >= 18 years of age and less than 80 years.
- Diagnosis of a ruptured (Hunt and Hess Grade I - III) or unruptured intracranial aneurysm at the time of the treatment
- Subject (or his/her legal representative) provides written informed consent for the use of his/her peri-procedural and follow-up data
Key exclusion criteria (9 listed)
- Diagnosis of Hunt and Hess Grade IV or V subarachnoid hemorrhage at the time of the treatment
- Severe co-morbidity associated with a life-expectancy of less than six months
- Poor neurological status at baseline
- Known allergies to Nitinol metal
- Known allergies to aspirin, heparin, ticlopidine, or clopidogrel or unable or unwilling to tolerate therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular Reconstruction DeviceAlso: ENTERPRISE, Codman ENTERPRISE, Codman VRDCORDIS ENTERPRISE™ VRD | Device | 1 Endovascular |
Primary outcome
The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)
Time frame: Intra-procedure
Successful intracranial VRD placement is defined as stable VRD placement with complete coverage of the aneurysm neck and parent artery patency. Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
3 secondary outcomes
Device or Procedure Related Adverse Events (AEs)
Time frame: index procedure to discharge; an average of 3.8 days
Satisfactory Coil Mass Position
Time frame: 6 months
Aneurysm Occlusion
Time frame: post procedure to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Intracranial Aneurysm
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bendszus Martin, MD principal investigator
Wuerzburg University Hospital
Boris Lubicz, MD principal investigator
Université Libre de Bruxelles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Codman & Shurtleff at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE) (time frame: Intra-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.