A Safety Evaluation of the Use of Magnetic-guided Iron Particles

NCT01519076 | Terminated Phase 1 DMC

• 1 other identifier: PTI_CS001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a prospective trial wherein each included subject will receive the experimental magnetically enhanced diffusion therapy. It will be conducted on a maximum of ten adult male or female patients who meet the inclusion and exclusion criteria and informed consent has been obtained. Subjects presenting in the emergency department with acute ischemic stroke and are eligible for tPA therapy may be considered for inclusion in the study.

Conditions

Ischemic Stroke

Keywords

stroke

Outcome Measures

Primary Outcomes (1)

• Safety: incidence and evaluation of any adverse effects associated with the investigational procedure compared with historical controls treated with tPA alone.

  The primary measures of safety will be mortality at 3 months and symptomatic ICH within the first 24 hours post-treatment. All intracerebral hemorrhages (ICH) will be classified radiographically using the ECASS criteria. The proportion of subjects with Type II parenchymal intracerebral hematomas within the first 24 hours post-treatment and the incidence of any asymptomatic hemorrhage within the first 24 hours will also be compared.

  90 days

Secondary Outcomes (1)

• Brain Recanalization and perfusion

  24 hours

Interventions

Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED) DEVICE

The PTI MED System is a magnetic-controlled infusion system which uses external energy (magnetic energy) to drive an agent (tPA) to the desired target (blood clot).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between 18 and 80 years of age.
• Subject has moderate to large (NIHSS ≥ 10 and ≤24) ischemic stroke
• Subject has an intracranial arterial occlusion of the middle cerebral artery (MCA), anterior cerebral artery (ACA), internal carotid artery (ICA), posterior cerebral artery (PCA) or distal basilar artery confirmed by CT or MR angiography.
• Subject is eligible for initiation of intravenous tPA within three hours of stroke onset, where time of stroke onset is defined as the last time the patient was witnessed to be at baseline.

You may not qualify if:

• Subject has known sensitivity to iron or PEG products.
• Subject has recently (within 30 days) received iron replacement therapy.
• Subject has known or suspect liver function abnormality.
• Subject has known or suspect severe renal impairment.
• Subject has a high-density lesion on baseline CT scan consistent with hemorrhage of any degree.
• Subject has a significant mass on baseline CT consistent with midline shift.
• Subject has a large (greater than one-third of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan.
• Subject has evidence of intraparenchymal tumor on baseline CT scan.
• Subject experiences a seizure at the onset of stroke.
• Subject has known hemosiderosis or hemochromatosis.
• Subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with MRI.
• Subject has a history of stroke within the last three months.
• Subject has a previous or existing intracranial hemorrhage, neoplasm, subarachnoid hemorrhage or arteriovenous malformation.
• Subject has experienced any active or recent (within 30 days) hemorrhage.
• Subject has systolic blood pressure \> 185 mmHg or diastolic \> 110 mmHg.

Sponsors & Collaborators

• Pulse Therapeutics: lead

Study Sites (2)

Hunter New England

New Lambton, New South Wales, Australia

Location

Eastern Health Services Box Hill Hospital

Box Hill, Victoria, Australia

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christopher Bladin, MD

  Eastern Health Services Box Hill Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 26, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

AU (2)