Ultrasound-assisted, Catheter-directed Thrombolysis for Acute Intermediate-high-risk Pulmonary Embolism (USAT IH-PE): Impact on Short- and Long-term Outcome, a Multi-center Experience. An Observational Retrospective and Prospective Multi-center Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Italy
ASST GOM Niguarda
RECRUITING
Milan
Contact Information
Primary
Alice Sacco, MD
alice.sacco@ospedaleniguarda.it
0039026444
Backup
Dario Brunelli, PhD
dario.brunelli@ospedaleniguarda.it
0039026444
Time Frame
Start Date: 2022-11-28
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 180
Treatments
EkoSonicTM Endovascular System (EKOSTM, Boston Scientific)
Patients hospitalized with acute intermediate-high risk PE treated with ultrasound-assisted, catheter-directed thrombolysis using EKOSTM.
Sponsors
Leads: Niguarda Hospital

This content was sourced from clinicaltrials.gov

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