Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study

NCT02994563 | Terminated

• 1 other identifier: AmGR01
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 4

Brief Summary

Prospective, single-arm, open label, Safety and Performance clinical investigation.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• All serious adverse events (notably at 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first).

  It will investigate whether the application of Amnis Thrombectomy device is a safe method, in acute stroke therapy, for obtaining recanalization of large vessels and with favorable patient outcome.

  24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first.

• All cause mortality (90 days).

  Determine the number of participants with treatment-related adverse events.

  3 months post-procedure

Secondary Outcomes (3)

• Arterial recanalization of the occluded target vessel in the immediate post-procedure angiogram.

  Immediate post-procedure angiogram.

• Proportion of patients with rapid neurological improvement as determined by a NIHSS ≤4.

  First 24 hours after treatment

• Good functional clinical outcome as determine by a modified Rankin Scale score of 0-2.

  First 24 hours after treatment.

Study Arms (1)

Open arm

EXPERIMENTAL

Thrombectomy device to be used to retrieve clot and restore blood flow.

Device: Thrombectomy Device

Interventions

Thrombectomy Device DEVICE

The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke

Open arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged18-85years.
• Subject is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the Amnis Thrombectomy Device.
• NIHSS score ≥8.
• Pre-stroke mRS (modified Rankin Scale) score of 0 to 1.
• Thrombolysis in cerebral infarction (TICI) ≤1 and causative occlusion of the M1 or M2 portion of the MCAs, anterior cerebral arteries, vertebral arteries, basilar artery ,or posterior cerebral arteries (P1 o rP2), confirmed by CT or MR angiography that is accessible to the Amnis thrombectomy device (i.e. according to IFU; 2-5.5 mm).
• ASPECTS of ≥6 based on CT or MRI that was performed within 60 min prior to the start of endovascular procedure.
• Subject or subject's legal guardian where regulations permit, signs the Patient Informed Consent and agrees that subject will attend follow-up visits.

You may not qualify if:

• Rapid neurological improvement prior to or at time of treatment suggesting resolution of signs/symptoms of stroke.
• Estimated time of symptom onset.
• Baseline NIHSS score \<8.
• BaselineNIHSS score ≥30 or state of coma.
• Baseline pre-stroke mRS score \>1.
• Baseline Thrombolysis in cerebral infarction (TICI) \> 2a.
• Known serious sensitivity to radiographic contrast agent.
• Arterial tortuosity, pre-existing stent and/o rother arterial disease that would prevent the device from reaching the target vessel.
• Evidence of a moderate/large core defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) \<6.
• Co-morbid conditions:
• Elevated blood pressure(systolic\>185 mm Hg or diastolic \>110 mm Hg)
• Use of warfarin anticoagulation with INR \>3.0.
• Platelet count \<30,000/mm³.
• Blood glucose concentration \<50 mg/dL (2.7 mmol/L).
• CT/MRI imaging demonstrate smultilobar infarction (hypodensity \>1/3 cerebral hemisphere).

Sponsors & Collaborators

• Amnis Therapeutics: lead

Study Sites (4)

Hospital Vall d'Hebron; Unidad Ictus

Barcelona, 08035, Spain

Location

Hospital Clinico of Barcelona; Section of Vascular Radiology & Neuroradiology

Barcelona, 08036, Spain

Location

Hospital Clínico Universitario (Valladolid); Dept. Neurology

Valladolid, 47003, Spain

Location

Karolinska Universitetssjukhuset i Solna

Stockholm, 171 76, Sweden

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Tommy Andersson, M.D.; Ph.D.

  Karolinska Institute, Neuroradiology Clinic, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

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: December 5, 2016
• First Posted: December 16, 2016
• Study Start: October 7, 2019
• Primary Completion: February 25, 2021
• Study Completion: March 1, 2021
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); ES (3)