Vibrato Aspiration System - Simple, Intuitive Approach to Clot Removal in Acute Pulmonary Embolism - a Safety & Feasibility Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Embolism Acute
• Intervention / Treatment: Device: Mechanical Thrombectomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shawn M Patterson; Phone Number: 7164323545; Email: spatterson@egrethealthcareventure.com
• Study Contact Backup: Name: Erin M Garcia; Phone Number: 716-863-2552; Email: egarcia@egrethealthcareventures.com

Study Locations

• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-848
      • Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu Uniwersytecki Szpital Kliniczny
      • Principal Investigator: Aleksander Araszkiewicz, Professor, MD, PhD
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 31-202
      • Krakowski Szpital Specjalistyczny im. św. Jana Pawła II
      • Principal Investigator: Grzegorz Kopeć, Professor, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subjects must meet all following general inclusion criteria:

1. Age ≥ 18 and ≤ 75 years.
2. Clinical signs, symptoms, and presentation consistent with acute PE;
3. PE symptom duration ≤ 14 days;
4. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
5. RV/LV ratio of ≥ 0.9 on CTA as assessed by investigator (site determined).
6. Systolic blood pressure ≥ 90 mmHg;
7. Stable heart rate < 130 BPM prior to procedure;
8. Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment
9. Informed Consent Form signed
10. Subject is willing and able to comply with all Clinical Investigation Plan required follow-up visit

Exclusion Criteria:

Subjects must not meet any of the following general exclusion criteria:

1. Thrombolytic use within 30 days of baseline CT angiogram
2. Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization (site determined)
3. Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg;
4. FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%;
5. Hematocrit < 28%;
6. Platelets < 100,000/ML;
7. Serum creatinine > 1.8 mg/dL;
8. International normalized ratio (INR) > 3;
9. Major trauma injury severity score (ISS) > 15 within the past 14 days
10. Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months, Pacemaker or Implantable Cardioverter Defibrillators;
11. Cardiovascular or pulmonary surgery within last 7 days;
12. Actively progressing cancer requiring chemotherapy
13. Known bleeding diathesis or coagulation disorder;
14. Left bundle branch block;
15. History of severe or chronic pulmonary arterial hypertension;
16. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%;
17. History of uncompensated heart failure;
18. History of underlying lung disease that is oxygen dependent;
19. History of chest irradiation;
20. History of heparin-induced thrombocytopenia (HIT);
21. Patients who are under intubation
22. Any contraindication to systemic or therapeutic doses of heparin or anticoagulants;
23. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated;
24. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention;
25. Life expectancy of < 90 days, as determined by Investigator;
26. Female who is pregnant or nursing;
27. Current participation in another investigational drug or device treatment study
28. History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days
29. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm study; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 hours
Efficacy Endpoint: Reduction in RV/LV Ratio	Reduction in RV/LV ratio from baseline to 48 hours or discharge by CT angiography	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint: Device-Related Death	Device-related death within 48 hours	48 hours
Safety Endpoint: Major Bleeding	Major bleeding within 48 hours	48 Hours
Safety Endpoint: Device-Related Clinical Deterioration	Device-related clinical deterioration within 48 hours	48 Hours
Safety Endpoint: Device-Related Pulmonary Vascular Injury	Device-related pulmonary vascular injury within 48 hours	48 Hours
Safety Endpoint: Cardiac Injury	Cardiac injury within 48 hours	48 Hours
Safety Endpoint: Any-Cause Mortality	Any-cause mortality within 30 days	30 Days
Safety Endpoint: Device-Related Serious Adverse Event	Device-related Serious Adverse Events (SAEs) within 30 days	30 Days
Safety Endpoint: Symptomatic Recurrence of Pulmonary Embolism	Symptomatic recurrence of Pulmonary Embolism (PE) within 30 days	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	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]	Procedure
Efficacy Endpoint: Procedural Change in Cardiac Index	Procedural change in cardiac index [measured in L/min/m^2]	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]	30 Days
Efficacy Endpoint: Length of Total Hospital Stay	Length of total hospital stay [measured in days]	30 Days
Efficacy Endpoint: Post-Index Procedure Hospital Length of Stay	Post-index-procedure hospital length of stay [measured in days]	30 Days
Efficacy Endpoint: Procedural Reduction in Pulmonary Artery Mean Pressure	Procedural reduction in pulmonary artery mean pressure [measured in mmHg]	Procedure
Efficacy Endpoint: Procedural Reduction in Pulmonary Artery Systolic Pressure	Procedural reduction in pulmonary artery systolic pressure [measured in mmHg]	Procedure
Efficacy Endpoint: Reduction in Total Pulmonary Vascular Resistance	Procedural reduction in total pulmonary vascular resistance [measured in mmHg ⋅ min/L]	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	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]	30 Days

Collaborators and Investigators

• Sponsor: Vicora, Inc.
• Collaborators: KCRI

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: DVT; Pulmonary Embolism; Clot
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: 26-VIC-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No