Aneurysmal Subarachnoid Hemorrhage Clinical Trial
Official title:
Safety and Performance of the Delta System in the Treatment of Vasospasm in Aneurysmal Subarachnoid Hemorrhage (aSAH) Patients
NCT number | NCT02129413 |
Other study ID # | DLT-CL-PR-01 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | April 24, 2014 |
Last updated | February 4, 2015 |
Start date | May 2014 |
The purpose of this study is to evaluate the safety and performance of the Delta system in the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage (aSAH) patients.
Status | Recruiting |
Enrollment | 23 |
Est. completion date | |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Male and female older than 18 years of age and no more than 75 years of age. 2. aSAH patients with secured aneurysm. 3. Patient has cerebral vasospasm and is anesthetized and intubated. 4. Cerebral vasospasm is manifested by: - Mean Flow Velocity (MFV) >120 cm/sec in the intracranial ICA (Internal carotid artery), MCA (middle cerebral artery) or ACA (anterior cerebral artery) or MFV >110 cm/sec in the PCA, or >85 cm/sec in the vertebral or basilar arteries, as measured by TCD (Trans Cranial Doppler). Or: - Extra/intracranial ratio for the carotid watershed (MCA, ACA, intracranial ICA)>3, or a proximal/distal ratio for the vertebrobasilar (VB) system > 2. Or: - Affected/contralateral MCA MFV ratio =1.5. Or - Affected / baseline MCA MFV ratio =1.5. AND: - Vasoconstriction of at least 33% in at least one of the main cerebral arteries, measured by Angiography (Digital Subtraction Angiography (DSA) or Computed Tomography Angiography (CTA). 5. Hemodynamically stable, including subjects who are treated for fever, hydrocephalus, rebleeding, infection or metabolic abnormalities and are stable. 6. For pre-menopausal females - a negative pregnancy test, using an accepted method of birth control and avoid breast feeding for the duration of the trial 7. A legally Authorized representative have signed informed consent. Exclusion Criteria: 1. WFNS score 5 2. Unsecured aneurysm or Intracranial/SAH of other than aneurysmal origin. 3. Signs attributable to serious aneurismal surgical procedure-related complications. 4. Patient underwent decompressive craniectomy. 5. S/p Carotid Endarterectomy, or other neck intervention. 6. Known carotid body tumor, past or present. 7. Hemodynamic instability due to cardiac arrhythmia or due to any other cause. 8. Had a myocardial infarction, unstable angina or syncope, congestive heart failure that require hospitalization or ejection fraction = 40% within the past 3 months. Note: Elevated Troponin is expected after aSAH and will not exclude patients. 9. Had a stroke, within the past 1 year or transient ischemic attack at the last 3 months. 10. Any anatomical variation or thrombotic finding that according to the physician judgment is not eligible. 11. Renal insufficiency (Creatinine X2 of the normal). 12. Allergic to contrast media with no response to steroid pretreatment. 13. Are unable or unwilling to fulfill the protocol follow-up requirements 14. Are enrolled in another concurrent clinical trial, without prior approval of Samson NS and the PI. 15. Have an uncontrolled comorbid medical condition that would adversely affect their health if they are enrolled. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Czech Republic | FN Brno | Jihlavská 20 625 00 Brno | |
Czech Republic | UVN Praha Central Military Hospital | Prague | |
Germany | Charite Universitätsmedizin Berlin | Berlin | |
Germany | Johann Wolfgang Goethe-Universität | Frankfurt | |
Germany | Neurochirurgische Universitätsklinik Georg-August-Universität | Göttingen | |
Germany | University of Heidelberg | Heidelberg | |
Israel | The Chaim Sheba Medical Center, Department of Neurosurgery | Tel Hashomer |
Lead Sponsor | Collaborator |
---|---|
Samson NeuroSciences |
Czech Republic, Germany, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device or procedure related (possibly, probably, or definitely) serious adverse events rate, from the treatment period and up to 30 days. | 30 days | Yes | |
Secondary | Decrease Mean Flow Velocity (MFV) of =15% below the maximal MVF measured prior to treatment, in at least one of the affected cerebral arteries, in at least one measuring during treatment | 7 days | No | |
Secondary | Increase diameter of =15% in at least one of the affected main cerebral arteries, measured by Digital Subtraction Angiography (DSA) or Computed Tomography Angiography (CTA) | 7 days | No | |
Secondary | Increase of =20% in PbtO2 above baseline prior to treatment measured by Licox® monitoring system during treatment | 7 days | No | |
Secondary | Increase of =20% in CBF above baseline prior to treatment measured by the CerOx monitor system during treatment | 7 days | No | |
Secondary | Mechanical performance of the Delta system | Lead shaft mechanical performance (e.g insertion, positioning/re positioning, fixation and retrieval) will be quantitatively measured | 7 days | No |
Secondary | Electrical performance of the Delta system | Electrical performance of the electrical stimulation unit will be quantitatively measured | 7 days | No |
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