Investigation of Clot in Ischemic Stroke and Hematoma Evacuation (INSIGHT)

Penumbra

Status: Completed

Conditions: Ischemic Stroke; Intracranial Hematoma

Treatments: Other: Minimally invasive surgery; Device: Mechanical thrombectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT04693767

CLP 15131

Details and patient eligibility

About

The aim of the study is to collect and analyze specimen from ischemic stroke patients undergoing thrombectomy procedures and from patients undergoing minimally invasive surgery for intracranial hematoma evacuation.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 Years of Age
• Frontline treatment with: Penumbra System for ischemic stroke patients eligible for mechanical thrombectomy or Artemis Neuro Evacuation device for intracranial hematoma evacuation in patients eligible for minimally invasive surgery (MIS)
• Extracted thrombus/embolus
• Informed consent is obtained from either the patient or legally authorized representative (LAR)

Exclusion criteria

• Pregnancy or positive pregnancy test according to site routine practice (only required for women of child bearing potential; serum or urine acceptable)
• Currently participating in an investigational drug or device clinical trial that may confound the ability to capture clot and/or influence clot composition. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible

Trial design

400 participants in 2 patient groups

Patients with ischemic stroke

Treatment:

Device: Mechanical thrombectomy

Patients with intracranial hematoma

Treatment:

Other: Minimally invasive surgery