Safety Study of the Rapid System for Acute Ischemic Stroke

Rapid Medical

Status and phase: Completed; Phase 1

Conditions: Acute Ischemic Stroke

Treatments: Device: Rapid System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01404403

002-07-01-RR

Details and patient eligibility

About

This is a safety study of the Rapid System for acute ischemic stroke.

Enrollment: 12 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥18 to <85 years old
• Pre stroke modified Rankin Scale (mRS) of ≤2
• A signed informed consent by patient or a legally acceptable representative

Exclusion criteria

• Pre-stroke life expectancy of less than 6 months
• Current participation in another investigational drug or device study
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Stroke patients

Other group

Treatment:

Device: Rapid System