NCT07685522

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 6, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

June 18, 2026

Last Update Submit

July 1, 2026

Conditions

Pulmonary Embolism Acute

Keywords

Pulmonary EmbolismClotDVT

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (19)

  • Safety Endpoint: Device-Related Death

    48 hours

  • Safety Endpoint: Major Bleeding

    48 Hours

  • Safety Endpoint: Device-Related Clinical Deterioration

    48 Hours

  • Safety Endpoint: Device-Related Pulmonary Vascular Injury

    48 Hours

  • Safety Endpoint: Cardiac Injury

    48 Hours

  • +14 more secondary outcomes

Study Arms (1)

Single arm study

EXPERIMENTAL

Vibrato™ Aspiration System for aspiration mechanical thrombectomy in the treatment of acute pulmonary embolism.

Device: Mechanical Thrombectomy

Interventions

Mechanical ThrombectomyDEVICE

Mechanical Thrombectomy for the treatment of Acute Pulmonary Embolism

Single arm study

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Thrombolytic use within 30 days of baseline CT angiogram
  • Pulmonary hypertension with peak pulmonary artery pressure \> 70 mmHg by right heart catheterization (site determined)
  • Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg;
  • FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90%;
  • Hematocrit \< 28%;
  • Platelets \< 100,000/ML;
  • Serum creatinine \> 1.8 mg/dL;
  • International normalized ratio (INR) \> 3;
  • Major trauma injury severity score (ISS) \> 15 within the past 14 days
  • Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months, Pacemaker or Implantable Cardioverter Defibrillators;
  • Cardiovascular or pulmonary surgery within last 7 days;
  • Actively progressing cancer requiring chemotherapy
  • Known bleeding diathesis or coagulation disorder;
  • Left bundle branch block;
  • History of severe or chronic pulmonary arterial hypertension;
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu Uniwersytecki Szpital Kliniczny

Poznan, Greater Poland Voivodeship, 61-848, Poland

Location

Krakowski Szpital Specjalistyczny im. św. Jana Pawła II

Krakow, Lesser Poland Voivodeship, 31-202, Poland

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Shawn M Patterson

CONTACT

7164323545spatterson@egrethealthcareventure.com

Erin M Garcia

CONTACT

716-863-2552egarcia@egrethealthcareventures.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2026

First Posted

July 6, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 6, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(2)