NCT04451525

REal-World Analyses of Stroke - Thrombus Occlusion REtrieval

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 710 (actual)
• Sponsor: Microvention-Terumo, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of MicroVention market-released acute ischemic stroke devices when used at the direction of the treating physician.

Detailed description

This is a prospective, multi-center, single arm, observational, Real World Evidence (RWE) post-market study with two cohorts. The primary objective of Cohort I of the RESTORE study is to determine the proportion of subjects achieving successful revascularization (mTICI ≥ 2b) with the SOFIA® Flow Plus 6F Aspiration Catheter when used in conjunction with the direct aspiration as first line treatment technique for patients with acute ischemic stroke in the anterior circulation based on collection of real-world evidence data. Secondary objectives include the evaluation of good functional outcome (defined as mRS ≤ 2 at day 90), revascularization time, and procedure related major neurological complications, all based on real-world evidence data collected. The objective of Cohort II of the study is to evaluate standard outcomes such as successful revascularization (mTICI ≥ 2b), good functional outcome (defined as mRS ≤ 2 at day 90), revascularization time, and procedure related major neurological complications based on real-world evidence data. Additional outcomes may be defined and research questions generated based on review of the collected data.

Conditions

• Acute Ischemic Stroke
• Vessel Occlusion
• Stroke
• Ischemic

Interventions

Type	Name	Description
DEVICE	MicroVention Mechanical Thrombectomy Devices as first-line treatment	Patient will be treated with mechanical thrombectomy at the direction of the treating physician

Timeline

• Start date: 2020-07-15
• Primary completion: 2025-05-29
• Completion: 2025-06-09
• First posted: 2020-06-30
• Last updated: 2025-06-18

Locations

37 sites across 1 country: United States

Regulatory

• FDA-regulated device study