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Safety Study of Carotid Body Neurostimulation to Treat Cerebral Vasospasm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02129413
Recruitment Status : Unknown
Verified April 2014 by Samson NeuroSciences.
Recruitment status was:  Recruiting
First Posted : May 2, 2014
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):
Samson NeuroSciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aneurysmal Subarachnoid Hemorrhage Cerebral Vasospasm Device: Delta system Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance of the Delta System in the Treatment of Vasospasm in Aneurysmal Subarachnoid Hemorrhage (aSAH) Patients
Study Start Date : May 2014
Estimated Primary Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Delta system treatment Device: Delta system



Primary Outcome Measures :
  1. Device or procedure related (possibly, probably, or definitely) serious adverse events rate, from the treatment period and up to 30 days. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 7 days ]
  2. 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) [ Time Frame: 7 days ]
  3. Increase of ≥20% in PbtO2 above baseline prior to treatment measured by Licox® monitoring system during treatment [ Time Frame: 7 days ]
  4. Increase of ≥20% in CBF above baseline prior to treatment measured by the CerOx monitor system during treatment [ Time Frame: 7 days ]
  5. Mechanical performance of the Delta system [ Time Frame: 7 days ]
    Lead shaft mechanical performance (e.g insertion, positioning/re positioning, fixation and retrieval) will be quantitatively measured

  6. Electrical performance of the Delta system [ Time Frame: 7 days ]
    Electrical performance of the electrical stimulation unit will be quantitatively measured



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02129413


Contacts
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Contact: Ronnie Levy +97297745606 clinical.affairs@samsonneuro.com

Locations
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Czech Republic
FN Brno Recruiting
Jihlavská 20 625 00 Brno, Czech Republic
Contact: Martin Smrcka, Prof       msmrcka@fnbrno.cz   
UVN Praha Central Military Hospital Recruiting
Prague, Czech Republic, 169 02
Contact: Vladimir Beneš, Prof.       vladimir.benes@uvn.cz   
Germany
Charite Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Peter Vajkoczy, Prof.       peter.vajkoczy@charite.de   
Johann Wolfgang Goethe-Universität Recruiting
Frankfurt, Germany, D-60528
Contact: Christian Senft, MD, PhD.       c.senft@med.uni-frankfurt.de   
Neurochirurgische Universitätsklinik Georg-August-Universität Recruiting
Göttingen, Germany, 37075
Contact: Veit Rohde, Prof       veit.rohde@med.uni-goettingen.de   
University of Heidelberg Recruiting
Heidelberg, Germany, D-69120
Contact: Oliver Sakowitz, Prof       oliver.sakowitz@med.uni-heidelberg.de   
Israel
The Chaim Sheba Medical Center, Department of Neurosurgery Recruiting
Tel Hashomer, Israel, 52621
Contact: Sagi Harnof, Dr.    972-3-5302650    Sagi.harnof@sheba.health.gov.il   
Sponsors and Collaborators
Samson NeuroSciences
Investigators
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Principal Investigator: Peter Vajkoczy, Prof. Charite - Universitätsmedizin, Department of Neurosurgery (Campus Virchow Klinikum), Berlin 113353, Germany

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Responsible Party: Samson NeuroSciences
ClinicalTrials.gov Identifier: NCT02129413     History of Changes
Other Study ID Numbers: DLT-CL-PR-01
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: April 2014

Keywords provided by Samson NeuroSciences:
Aneurysmal subarachnoid hemorrhage
Subarachnoid hemorrhage
Cerebral vasospasm
Ruptured aneurysm
Delayed Cerebral Ischemia
Delayed Ischemic Deficit
Delayed ischemic neurological deficit
Neurostimulation
Carotid body

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases