Safety Study of Carotid Body Neurostimulation to Treat Cerebral Vasospasm

NCT02129413 | Unknown

• 1 other identifier: DLT-CL-PR-01
• Study Type: interventional
• Target: 23
• Locations: 3 countries
• Sites: 7

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Cerebral Vasospasm

Keywords

Aneurysmal subarachnoid hemorrhage; Subarachnoid hemorrhage; Cerebral vasospasm; Ruptured aneurysm; Delayed Cerebral Ischemia; Delayed Ischemic Deficit; Delayed ischemic neurological deficit; Neurostimulation; Carotid body

Outcome Measures

Primary Outcomes (1)

• Device or procedure related (possibly, probably, or definitely) serious adverse events rate, from the treatment period and up to 30 days.

  30 days

Secondary Outcomes (6)

• 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

• 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

• Increase of ≥20% in PbtO2 above baseline prior to treatment measured by Licox® monitoring system during treatment

  7 days

• Increase of ≥20% in CBF above baseline prior to treatment measured by the CerOx monitor system during treatment

  7 days

• Mechanical performance of the Delta system

  7 days

Study Arms (1)

Delta system treatment

EXPERIMENTAL

Device: Delta system

Interventions

Delta system DEVICE

Delta system treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female older than 18 years of age and no more than 75 years of age.
• aSAH patients with secured aneurysm.
• Patient has cerebral vasospasm and is anesthetized and intubated.
• 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).
• Hemodynamically stable, including subjects who are treated for fever, hydrocephalus, rebleeding, infection or metabolic abnormalities and are stable.
• 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
• A legally Authorized representative have signed informed consent.

You may not qualify if:

• WFNS score 5
• Unsecured aneurysm or Intracranial/SAH of other than aneurysmal origin.
• Signs attributable to serious aneurismal surgical procedure-related complications.
• Patient underwent decompressive craniectomy.
• S/p Carotid Endarterectomy, or other neck intervention.
• Known carotid body tumor, past or present.
• Hemodynamic instability due to cardiac arrhythmia or due to any other cause.
• 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.
• Had a stroke, within the past 1 year or transient ischemic attack at the last 3 months.
• Any anatomical variation or thrombotic finding that according to the physician judgment is not eligible.
• Renal insufficiency (Creatinine X2 of the normal).
• Allergic to contrast media with no response to steroid pretreatment.
• Are unable or unwilling to fulfill the protocol follow-up requirements
• Are enrolled in another concurrent clinical trial, without prior approval of Samson NS and the PI.
• Have an uncontrolled comorbid medical condition that would adversely affect their health if they are enrolled.

Sponsors & Collaborators

• Samson NeuroSciences: lead

Study Sites (7)

FN Brno

Jihlavská 20 625 00 Brno, Czechia

RECRUITING

UVN Praha Central Military Hospital

Prague, 169 02, Czechia

RECRUITING

Charite Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Johann Wolfgang Goethe-Universität

Frankfurt, D-60528, Germany

RECRUITING

Neurochirurgische Universitätsklinik Georg-August-Universität

Göttingen, 37075, Germany

RECRUITING

University of Heidelberg

Heidelberg, D-69120, Germany

RECRUITING

The Chaim Sheba Medical Center, Department of Neurosurgery

Tel Litwinsky, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial; Aneurysm, Ruptured

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aneurysm

Study Officials

• Peter Vajkoczy, Prof.

  Charite - Universitätsmedizin, Department of Neurosurgery (Campus Virchow Klinikum), Berlin 113353, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronnie Levy

CONTACT

+97297745606; clinical.affairs@samsonneuro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 2, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2015
• Last Updated: February 5, 2015

Record last verified: 2014-04

Locations

CZ (2); IL (1); DE (4)