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A Feasibility Study of the Surpass Aneurysm-Embolization System in Intracranial Arteries.


- candidate number6589
- NTR NumberNTR2054
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-okt-2009
- Secondary IDsSP-02 Surpass Medical
- Public TitleA Feasibility Study of the Surpass Aneurysm-Embolization System in Intracranial Arteries.
- Scientific TitleA Feasibility Study of the Surpass Aneurysm-Embolization System in Intracranial Arteries.
- ACRONYMSP-02
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedIntracranial aneurysm
- Inclusion criteria1. Subject understands the nature of the procedure and provides written informed consent;
2. Subject is willing to return to the investigational site for the thirty day and six month follow-up evaluations;
3. Age 18 years to 80 years;
4. Subject with a non-ruptured saccular or fusiform intracranial aneurysm arising from a parent vessel with a diameter of > 2mm and < 6mm;
5. Subject with an aneurysm that cannot be treated or is difficult to be treated with current available surgical or endovascular techniques.
- Exclusion criteria1. Pregnancy and lactating women;
2. Participation in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study;
3. Allergy or contraindication to aspirin, clopidogrel, heparin, local or general anesthesia;
4. History of life threatening allergy to contrast dye;
5. Major surgery within previous 30 days or planned in the next 90 days after enrollment date;
6. Dementia or psychiatric problem that prevents the patient from completing required follow up;
7. Co-morbid conditions that may limit survival to less than one year;
8. Subject with anatomy not appropriate for endovascular treatement due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy;
9. Subject with an intracranial mass (tumor (except meningioma), abscess, or other infection), or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region;
10. Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions;
11. Subject has a serum creatinine level greater than 2.0 mg/dL (within 7 days of procedure) which the investigator determines restricts the use of contrast agents;
12. Subject has a previously implanted intracranial stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date;
13. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to enrollment date;
14. Subject has a previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date;
15. Subject has uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms;
16. Subject had a subarachnoid hemorrhage within 12 weeks prior to the enrollment date;
17. Subject with resistance to ASA and/or Clopidogrel;
18. Subject with two or more aneurysms in associated distribution - unless the device is used to treat both aneurysms;
19. Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm;
20. Target aneurysm is expected to require more than one device.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2010
- planned closingdate1-jun-2011
- Target number of participants10
- InterventionsEndovascular treatment: A technique has been developed, in which a self-expanding device (Surpass Aneurysm-Embolization System), is placed across the aneurysm neck. This device attempts to restore blood flow through the main artery and in addition, to cause the aneurysm to become occluded. The device is a metal mesh, tubular shaped braided device that is compressed and placed into a catheter that is “threaded” up into the blood vessel in the head and is placed across the neck of the aneurysm.
- Primary outcome1. Adverse Events: For all subjects enrolled into the study, the incidence of adverse events will be assessed during the procedure, immediately post-procedure and through discharge. For all subjects with a deployed device, adverse events will be assessed during the procedure, immediately post-procedure, at discharge, at thirty days and six months;
2. Technical Feasibility: For all subjects with a deployed device, evaluation of percent occlusion will be assessed at six months after treatment. Successful device placement will be angiographically assessed immediately post-procedure.
- Secondary outcomeNeurological status: For all subjects with a deployed device clinical/neurological outcome will be assessed using neurological evaluations (NIH Stroke Scale, Modified Rankin Scale) by qualified personnel after the procedure, at thirty days and six months after treatment compared to the baseline evaluation.
- TimepointsSubjects will receive a follow-up evaluation at thirty days (+ two weeks) and at six months (+ four weeks) with a follow-up angiography at six months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J. Vries, de
- CONTACT for SCIENTIFIC QUERIES Marc Litzenberg
- Sponsor/Initiator Surpass Medical Ltd.
- Funding
(Source(s) of Monetary or Material Support)
Surpass Medical Ltd.
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD13-okt-2009 - 3-jul-2010


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