Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism
NCT06362928 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-07-28
Summary
This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).
Conditions
- Pulmonary Embolism Acute
Interventions
- DEVICE
-
ATC System
The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE
Sponsors & Collaborators
-
Akura Medical
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-15
- Primary Completion
- 2026-01-31
- Completion
- 2026-02-28
- FDA Device
- Yes
Countries
- Austria
Study Locations
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