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

NCT ID: NCT02994563

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-07
• Study Completion Date: 2021-03-01

Brief Summary

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

Detailed Description

The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke. Pre-CE mark clinical investigation. Population will be subjects with documented untreated, acute ischemic stroke with large vessel occlusion.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open arm

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

Group Type: EXPERIMENTAL

Thrombectomy Device

Intervention Type: DEVICE

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

Interventions

Thrombectomy Device

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Aged18-85years.

3. Subject is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the Amnis Thrombectomy Device.

4. NIHSS score ≥8.

5. Pre-stroke mRS (modified Rankin Scale) score of 0 to 1.

6. 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).

7. ASPECTS of ≥6 based on CT or MRI that was performed within 60 min prior to the start of endovascular procedure.

8. Subject or subject's legal guardian where regulations permit, signs the Patient Informed Consent and agrees that subject will attend follow-up visits.

Exclusion Criteria

1. Rapid neurological improvement prior to or at time of treatment suggesting resolution of signs/symptoms of stroke.

2. Estimated time of symptom onset.

3. Baseline NIHSS score <8.

4. BaselineNIHSS score ≥30 or state of coma.

5. Baseline pre-stroke mRS score >1.

6. Baseline Thrombolysis in cerebral infarction (TICI) > 2a.

7. Known serious sensitivity to radiographic contrast agent.

8. Arterial tortuosity, pre-existing stent and/o rother arterial disease that would prevent the device from reaching the target vessel.

9. Evidence of a moderate/large core defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) <6.

Co-morbid conditions:

10. Elevated blood pressure(systolic>185 mm Hg or diastolic >110 mm Hg)

11. Use of warfarin anticoagulation with INR >3.0.

12. Platelet count <30,000/mm³.

13. Blood glucose concentration <50 mg/dL (2.7 mmol/L).

14. CT/MRI imaging demonstrate smultilobar infarction (hypodensity >1/3 cerebral hemisphere).

15. CT or MRI evidence of mass effect, signs of hemorrhage, arteriovenous malformation or aneurysm or intra-cranial tumor (except small meningioma).

16. Angiographic evidence of carotid dissection, complete cervical carotid occlusions or vasculitis.

17. Clinical Symptoms or CT/MRI imaging suggest subarachnoid hemorrhage.

18. Imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target lesion, moderate/large infarct with poor collateral circulation, etc.).

General - related to the protocol or device:

19. Known sensitivity to nickel, titanium metals or their alloys.

20. Subject who requires hemodialysis or peritoneal dialysis, or who has a contraindication to an angiogram for whatever reason.

21. Current participation in another investigational drug or device study.

22. Female who is pregnant or lactating or has a positive pregnancy test at time of admission.

23. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).

24. Subject has a life expectancy of <90 days.

25. Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amnis Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tommy Andersson, M.D.; Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institute, Neuroradiology Clinic, Stockholm, Sweden

Locations

Hospital Vall d'Hebron; Unidad Ictus

Barcelona, , Spain

Hospital Clinico of Barcelona; Section of Vascular Radiology & Neuroradiology

Barcelona, , Spain

Hospital Clínico Universitario (Valladolid); Dept. Neurology

Valladolid, , Spain

Karolinska Universitetssjukhuset i Solna

Stockholm, , Sweden

Countries

Spain; Sweden

Other Identifiers

AmGR01

Identifier Type: -

Identifier Source: org_study_id