NCT06143969 Ultrasound-assisted, Catheter-directed Thrombolysis for Acute Intermediate-high-risk Pulmonary Embolism
| NCT ID | NCT06143969 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Niguarda Hospital |
| Condition | Pulmonary Embolism |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2022-11-28 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2022-11-28 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria * 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). Exclusion Criteria * 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 & Investigator
Frequently Asked Questions
Who can join the NCT06143969 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Embolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06143969 currently recruiting?
Yes, NCT06143969 is actively recruiting participants. Contact the research team at alice.sacco@ospedaleniguarda.it for enrollment information.
Where is the NCT06143969 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06143969 clinical trial?
NCT06143969 is sponsored by Niguarda Hospital. The trial plans to enroll 180 participants.