Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00653536
Other study ID # 07-08-010
Secondary ID
Status Withdrawn
Phase Phase 1
First received April 2, 2008
Last updated January 11, 2017
Start date March 2008
Est. completion date January 2013

Study information

Verified date January 2017
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Patients with acute ischemic stroke and persistent arterial occlusion following failed mechanical revascularization, who can undergo NeuroFlo treatment within 18 hours of last time symptom free, will be eligible for enrollment to assess the safety and feasibility of the NeuroFlo catheter in treating ischemic stroke patients with persistent arterial occlusion following attempted thrombectomy. The NeuroFlo catheter is designed to partially obstruct the abdominal descending aorta thereby increasing blood flow to the brain. Cerebral perfusion is improved by diverting more blood through vessels as well as by expansion of the collateral circulation. Improved regional perfusion leads to clinical improvement.


Description:

Patients with occlusion of a proximal artery experience prompt diversion of flow through collaterals and retrograde perfusion of the occluded arterial tree. Collateral perfusion sustains the penumbra and may lessen stroke severity provided recanalization of the occluded artery occurs. Thrombectomy attempts to achieve recanalization of the occluded artery, but 36% of patients (90/252 in MERCI and MultiMERCI studies) experienced persistent arterial occlusion (PAO, defined as TICI flow 0-1). PAO following attempted thrombectomy was associated with high mortality, with 53% dead at 90 days. Of the survivors, only 5% achieved mRS of 0-2. At present, there are no therapies that have been shown to improve these risks. Data obtained from a clinically indicated CT at 24 hours will be used to monitor for safety.

The safety endpoints for this study will be the proportion of patients who experience:

- Mortality and neurological deterioration (defined as an increase of ≥4 points on the NIHSS) at 5 days post treatment

- Change in neurological status and adverse events from baseline through 30 days from treatment

Other endpoints include:

- Change in neurological status and adverse events from baseline through 90 days from treatment

- The incidence of hemorrhagic transformation or other intracerebral bleeding will be assessed at 5 days post treatment.

- Cerebral blood flow changes associated with device therapy will be assessed through multimodal CT or MRI studies acquired at baseline and 3 hours post treatment.

- Potential patient benefit will be assessed through collection of neurological indices (NIHSS etc.) at baseline, 24 hours post-procedure, day 5 (or discharge), 30 days and 90 days.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age =18 years

- Acute cerebral ischemia due to occlusion of the internal carotid or middle cerebral artery

- NIHSS 8-25 (inclusive)

- Persistent arterial occlusion (defined as TICI 0 or 1) following failed mechanical revascularization (ref Table 2)

- Able to undergo NeuroFlo treatment within 18 hours of symptom onset (or from last time known normal)

- Informed consent from patient or legally authorized representative

- Negative pregnancy test in females of child-bearing potential

Exclusion Criteria:

- Etiology other than cerebral ischemia

- Acute hypodense parenchymal lesion or effacement of cerebral sulci in more than 1/3 of the middle cerebral artery territory

- Brainstem or cerebellar stroke

- Systolic blood pressure (BP) >220 mm Hg, or diastolic (BP) >140 mm Hg that cannot be lowered with medical management

- Any use of intravenous or intra-arterial thrombolytic medication

- Known secured or unsecured cerebral aneurysm or vascular malformation on CTA or MRA or history thereof

- Imaging evidence of current intracranial bleeding

- History of intracerebral hemorrhage

- Any aortic or femoral endovascular graft

- Aortic surgery within 6 weeks prior to the time of enrollment

- Known heparin sensitivity or allergy

- Participation in another therapeutic/treatment research protocol

- Any intracranial pathology interfering with the imaging assessments

- Current congestive or decompensated heart failure

- Known ejection fraction (EF) < 30% or evidence of NYHA Class IV or ACC/AHA Stage D heart failure within the past 3 months

- Known or echo evidence of aortic regurgitation = 3+

- Myocardial infarction within last 3 months

- Evidence of acute MI on ECG or by cardiac enzymes

- Current or recent Class III or IV angina despite medical/surgical treatment

- INR > 1.7

- Platelet count < 100,000

- Creatinine > 1.5 times local laboratory standard

- Patients with cerebral arterial perforation or dissection due to attempted thrombectomy

- Patients with complications of femoral artery cannulation

- Patients with aortic diameter greater than 28 mm or smaller than 11 mm in diameter measured within 6 cm above and below the midpoint of the renal ostia (for 7Fr NeuroFlo Device)

- Evidence of aortic aneurysm

- High-grade iliac stenosis or vascular tortuosity that could prevent safe delivery and/or positioning of the NeuroFlo catheter

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
NeuroFlo
The device will be inflated for 45 minutes in acute ischemic stroke patients who have failed mechanical recanalization.

Locations

Country Name City State
United States UCLA Medical Center Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles CoAxia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality and neurological deterioration at 5 days post treatment day 5 Yes
Secondary Change in neurological status and adverse events from baseline through 30 days from treatment Day 30 Yes
Secondary Change in neurological status and adverse events from baseline through 90 days from treatment 90 days No
Secondary Incidence of hemorrhagic transformation or other intracerebral bleeding at 5 days post treatment day 5 Yes
Secondary Cerebral blood flow changes associated with device therapy assessed through multimodal MRI studies acquired at baseline and 3 hours post treatment obtained routinely at UCLA post IV or IA intervention in acute stroke patients 3 hr and 24 hr Yes
See also
  Status Clinical Trial Phase
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Enrolling by invitation NCT06074081 - Comparison of 4-weeks of Motor Relearning Program and Mirror Therapy in Improving Upper Limb Motor Function in Stroke Patients. N/A
Terminated NCT04039178 - Efficacy of EMF BCI Based Device on Acute Stroke N/A
Completed NCT04521634 - Glycaemic Variability in Acute Stroke
Completed NCT03477188 - The Effects of Somatosensory and Vestibular Rehabilitation Additional Conventional Therapy on Balance in Patients With Acute Stroke. N/A
Recruiting NCT05065216 - Treatment of Acute Ischemic Stroke (ReMEDy2 Trial) Phase 2/Phase 3
Recruiting NCT02677415 - Impact of Anesthesia Type on Outcome in Patients With Acute Ischemic Stroke (AIS) Undergoing Endovascular Treatment N/A
Recruiting NCT01541163 - Heart and Ischemic STrOke Relationship studY N/A
Completed NCT01210729 - Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke Phase 2
Recruiting NCT00785343 - Study of Robot-assisted Arm Therapy for Acute Stroke Patients Phase 1
Completed NCT04779710 - How Does Dysphagia Assessment in Acute Stroke Affect Pneumonia?
Active, not recruiting NCT03635749 - Intensive Medical Therapy for High-risk Intracranial or Extracranial Atherosclerosis Phase 3
Recruiting NCT06149754 - BraiN20® Monitoring in Acute Stroke Undergoing Thrombectomy
Recruiting NCT04491695 - Tirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke Phase 2/Phase 3
Recruiting NCT04283760 - Investigation of the Reliability and Validity of the Movement Imagination Questionnaire - Revised Second in Acute Stroke Patients
Recruiting NCT05454397 - A Study on the Status of Nutritional Risk Screening and Nutritional Therapy in Neurology Hospitalized Stroke Patients
Completed NCT04488692 - Early Functional Training in Acute Stroke Inpatient Ward N/A
Recruiting NCT04214522 - Reliability and Validity of the Kinesthetic and Visual Imagery Questionnaire in Acute Stroke Patients
Not yet recruiting NCT04157231 - Essential Acute Stroke Care in Low Resource Settings: a Pilot studY N/A
Recruiting NCT05469438 - IMAS Optimization and Applicability in an Acute Stroke Setting.

External Links