Vibrato Aspiration System - Simple, Intuitive Approach to Clot Removal in Acute Pulmonary Embolism - a Safety & Feasibility Study
NCT07685522 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-08-25
Summary
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vibrato™ Aspiration System for aspiration mechanical thrombectomy in the treatment of acute PE. This is the First in Man clinical study.
Conditions
- Pulmonary Embolism Acute
Interventions
- DEVICE
-
Mechanical Thrombectomy
Mechanical Thrombectomy for the treatment of Acute Pulmonary Embolism
Sponsors & Collaborators
-
KCRI
collaborator OTHER -
Vicora, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-21
- Primary Completion
- 2026-10-31
- Completion
- 2026-12-31
Countries
- Poland
Study Locations
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