An interventional study of Mechanical Thrombectomy in Pulmonary Embolism Acute, sponsored by Vicora, Inc.. Recruiting at 2 sites in Poland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Vicora, Inc. · Not applicable, Interventional, and Device feasibility
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.
The study objective is to evaluate the safety and effectiveness of the Vibrato™ Aspiration System Aspiration System (hereafter referred to as Vibrato™ Aspiration System) for aspiration mechanical thrombectomy in the treatment of acute PE.
The Vibrato™ Aspiration System is a vibration-assisted aspiration thrombectomy device including attributes designed to improve trackability, maintain a low-profile configuration, and operate without capital equipment. In addition, the Vibrato™ Aspiration System features a novel vibrating distal tip designed to enhance thrombus removal during aspiration while minimizing vascular injury. The vibrating mechanism may reduce procedure times, improve clot removal efficiency, and decrease the need for adjunctive interventions.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's planned enrollment of 10 is below the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →This is the only study on the registry with Vicora, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects must meet all following general inclusion criteria:
Exclusion Criteria:
Subjects must not meet any of the following general exclusion criteria:
Vibrato™ Aspiration System for aspiration mechanical thrombectomy in the treatment of acute pulmonary embolism.
Device: Mechanical Thrombectomy
Mechanical Thrombectomy for the treatment of Acute Pulmonary Embolism
Safety Endpoint: Major Adverse Events
Major Adverse Events, a composite of: * Device-related death within 48 hours * Major bleeding within 48 hours * Device-related AEs within 48 hours, including: * Clinical deterioration * Pulmonary vascular injury * Cardiac injury
Time frame: 48 hours
Efficacy Endpoint: Reduction in RV/LV Ratio
Reduction in RV/LV ratio from baseline to 48 hours or discharge by CT angiography
Time frame: 48 hours
Safety Endpoint: Device-Related Death
Device-related death within 48 hours
Time frame: 48 hours
Safety Endpoint: Major Bleeding
Major bleeding within 48 hours
Time frame: 48 Hours
Safety Endpoint: Device-Related Clinical Deterioration
Device-related clinical deterioration within 48 hours
Time frame: 48 Hours
Safety Endpoint: Device-Related Pulmonary Vascular Injury
Device-related pulmonary vascular injury within 48 hours
Time frame: 48 Hours
Safety Endpoint: Cardiac Injury
Cardiac injury within 48 hours
Time frame: 48 Hours
Safety Endpoint: Any-Cause Mortality
Any-cause mortality within 30 days
Time frame: 30 Days
Safety Endpoint: Device-Related Serious Adverse Event
Device-related Serious Adverse Events (SAEs) within 30 days
Time frame: 30 Days
Safety Endpoint: Symptomatic Recurrence of Pulmonary Embolism
Symptomatic recurrence of Pulmonary Embolism (PE) within 30 days
Time frame: 30 Days
Efficacy Endpoint: Modified Miller Index Score
Change in modified Miller Index Score (MMIS) between baseline and 48 hours post-procedure as assessed by CTA
Time frame: 48 Hours
Efficacy Endpoint: Change in Mean Pulmonary Artery Pressure
Change in mean pulmonary artery pressure measured invasively in the central pulmonary arteries before vs. after the endovascular procedure \[measured in mmHg\]
Time frame: Procedure
Efficacy Endpoint: Procedural Change in Cardiac Index
Procedural change in cardiac index \[measured in L/min/m\^2\]
Time frame: Procedure
Efficacy Endpoint: Length of ICU Stay, Associated with Index Procedure
Length of stay in the ICU associated with the index procedure \[measured in days\]
Time frame: 30 Days
Efficacy Endpoint: Length of Total Hospital Stay
Length of total hospital stay \[measured in days\]
Time frame: 30 Days
Efficacy Endpoint: Post-Index Procedure Hospital Length of Stay
Post-index-procedure hospital length of stay \[measured in days\]
Time frame: 30 Days
Efficacy Endpoint: Procedural Reduction in Pulmonary Artery Mean Pressure
Procedural reduction in pulmonary artery mean pressure \[measured in mmHg\]
Time frame: Procedure
Efficacy Endpoint: Procedural Reduction in Pulmonary Artery Systolic Pressure
Procedural reduction in pulmonary artery systolic pressure \[measured in mmHg\]
Time frame: Procedure
Efficacy Endpoint: Reduction in Total Pulmonary Vascular Resistance
Procedural reduction in total pulmonary vascular resistance \[measured in mmHg ⋅ min/L\]
Time frame: Procedure
Efficacy Endpoint: Change from Baseline in Dyspnea Severity by mMRC Score
Change from baseline in Dyspnea severity by mMRC score at the 48-hour visit
Time frame: 48 Hours
Efficacy Endpoint: Change from Baseline in Dyspnea Severity by mMRC Score
Change from baseline in Dyspnea severity by mMRC score \[Time Frame: at the 30 days visit\]
Time frame: 30 Days
Plan to share: No
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