Trials Sponsors Conditions Drugs Pricing

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 DeviceDevice

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

Open arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Amnis Therapeutics
Industrylead

Study Sites (4)

Hospital Vall d'Hebron; Unidad Ictus

Barcelona, 08035, Spain

Hospital Clinico of Barcelona; Section of Vascular Radiology & Neuroradiology

Barcelona, 08036, Spain

Hospital Clínico Universitario (Valladolid); Dept. Neurology

Valladolid, 47003, Spain

Karolinska Universitetssjukhuset i Solna

Stockholm, 171 76, Sweden

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

Tommy Andersson, M.D.; Ph.D.
Karolinska Institute, Neuroradiology Clinic, Stockholm, Sweden
PRINCIPAL INVESTIGATOR

Enrollment

5 participants (actual enrollment reported by the registry).

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

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

Open arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

Open arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations