Status:
COMPLETED
Hydro-mechanical Defragmentation of Pulmonary Embolism
Lead Sponsor:
Assiut University
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Evaluating the safety and outcomes of hydro-mechanical defragmentation of high risk pulmonary embolism with contraindication for thrombolytic therapy
Detailed Description
In high risk pulmonary embolism , the main aim of therapy is to rapidly recanalize the affected pulmonary arteries with thrombolysis or embolectomy; to decrease right ventricular afterload and reverse...
Eligibility Criteria
Inclusion
- Patients with angiographically confirmed acute high risk pulmonary embolism with shock index \>1.
- Pulmonary arterial occlusion with \>50% involvement of the central (main and/or lobar) pulmonary , and pulmonary hypertension (mean pulmonary artery pressure \>25 mmHg)
- Patients with high risk pulmonary embolism who cannot receive fibrinolysis
- Patients with acute intermediate-high risk pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV (right ventricle) dysfunction, or major myocardial necrosis)
Exclusion
- Patients with echocardiographically confirmed right sided thrombi.
- Patients with low-risk pulmonary embolism or intermediate-low risk acute pulmonary embolism with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening
- Anaphylactic reaction to contrast media.
- Acute renal failure or severe chronic non-dialysis dependent kidney disease.
- Uncooperative patient
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04099186
Start Date
September 1 2019
End Date
January 30 2021
Last Update
July 20 2021
Active Locations (1)
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1
Assiut University
Asyut, Egypt, 71515