NCT06143969

Brief Summary

The purpose of this retrospective and prospective multicenter study is to evaluate the incidence of pulmonary hypertension (PH) within 6 months from ultrasound-assisted, Catheter-directed Thrombolysis for acute intermediate- high-risk Pulmonary Embolism

Trial Health

77
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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

Study Progress85%
Nov 2022Mar 2027

Study Start

First participant enrolled

November 28, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

November 15, 2023

Last Update Submit

April 13, 2026

Conditions

Pulmonary Embolism

Keywords

pulmonary embolismintermediate high-riskUltrasound-assistedCatheter-directed Thrombolysis

Outcome Measures

Primary Outcomes (1)

  • development of pulmonary hypertension

    number of cases

    6 months from treatment

Secondary Outcomes (7)

  • changes of echocardiographic parameters

    24 hours after the treatment and at 3-6 months follow-up

  • death

    within 6 months from treatment

  • death

    within 6 months from treatment

  • PE

    within 6 months from treatment

  • Major bleeding within 6 months from treatment (Bleeding Academic Research Consortium-major bleedings defined as BARC 3-5 events; clinically relevant non major bleedings defined as BARC 2 event) (number of events)

    within 6 months from treatment

  • +2 more secondary outcomes

Study Arms (1)

EkoSonicTM Endovascular System (EKOSTM, Boston Scientific)

Patients hospitalized with acute intermediate-high risk PE treated with ultrasound-assisted, catheter-directed thrombolysis using EKOSTM.

Procedure: ultrasound-assisted, catheter-directed thrombolysis

Interventions

ultrasound-assisted, catheter-directed thrombolysisPROCEDURE

After 10 hours of alteplase infusion and EKOSTM ultrasound, the therapy is stopped, the EKOSTM catheter is removed, and the puncture site (internal jugular vein or femoral vein) has to be compressed.

Also known as: EkoSonicTM Endovascular System (EKOSTM, Boston Scientific)
EkoSonicTM Endovascular System (EKOSTM, Boston Scientific)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients hospitalized with intermediate high-risk pulmonary embolism

You may qualify if:

  • Patients admitted with acute intermediate-high risk PE, defined according to ESC guidelines
  • Symptoms onset within previous 14 days associated or not with deep venous thrombosis
  • Confirmation of the PE by contrast-enhanced computed tomography of the chest with embolus located in at least one main or proximal lower lobe pulmonary artery
  • Echocardiographic parameters of RV disfunction
  • Patients with high-risk PE or hemodynamic deterioration on anticoagulation, who have absolute contraindications (high bleeding risk) to systemic thrombolysis and symptoms onset during the last 14 days. Patients with surgery-related embolic complications are also included (within 48 hours).

You may not qualify if:

  • Age \< 18 years old
  • Patients unable to give informed consent
  • Pregnancy
  • Patients received fibrinolytic drugs in the preceding 4 days
  • Bleeding diathesis
  • Known bleeding disorder
  • Low platelet count (\< 100.000/uL
  • Gastrointestinal bleeding in the preceding 3 month
  • Any ongoing known presence of malignant neoplasia months
  • Advanced chronic kidney disease (defined as 11.000/uL)
  • Gastrointestinal bleeding in the preceding 3 month
  • Any ongoing known presence of malignant neoplasia at admission with survival rate \< 6
  • Advanced chronic kidney disease (defined as eGFR \< 30 ml/min or on dialysis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST GOM Niguarda

Milan, Italia, 20162, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Alice Sacco, MD

CONTACT

0039026444alice.sacco@ospedaleniguarda.it

Dario Brunelli, PhD

CONTACT

0039026444dario.brunelli@ospedaleniguarda.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 22, 2023

Study Start

November 28, 2022

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)