Trials / Completed
CompletedNCT05429658
Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System
A Prospective, Single-arm, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Route 92 Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients.
Detailed description
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspirate emboli in acute ischemic stroke patients. The study design is an interventional, prospective, single-arm, open label clinical trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Thrombectomy | The Route 92 Medical Reperfusion System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid, middle cerebral, basilar and vertebral arteries. |
Timeline
- Start date
- 2019-09-27
- Primary completion
- 2021-11-22
- Completion
- 2022-02-24
- First posted
- 2022-06-23
- Last updated
- 2024-03-28
Locations
2 sites across 1 country: New Zealand
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05429658. Inclusion in this directory is not an endorsement.