Status:
UNKNOWN
Catheter-Directed Pulmonary Reperfusion in Treatment of Pulmonary Embolism Patients
Lead Sponsor:
Assiut University
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
* Primary objective: to evaluate the success and mortality rates of catheter-directed reperfusion therapy in comparison to traditional use of systemic intravenous fibrinolytic therapy, will focus at s...
Detailed Description
Venous thromboembolic disease represents one of the most important causes of cardiovascular death in the world. Symptomatic pulmonary embolism (PE) occurs in about 500,000 patients annually, with an e...
Eligibility Criteria
Inclusion
- Age \>18 years old.
- Both gender males and females.
- 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 dysfunction of the right ventricle and elevated troponin.
- patients with high risk pulmonary embolism who remain unstable after receiving fibrinolysis
- patients with high risk PE pulmonary embolism who cannot receive fibrinolysis
- patients with intermediate high risk PE 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 PE pulmonary embolism or submassive acute PE pulmonary embolism with minor RV (right ventricle) 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 :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04911192
Start Date
June 30 2021
End Date
December 30 2023
Last Update
June 18 2021
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