NCT04911192

Catheter-Directed Pulmonary Reperfusion in Treatment of Pulmonary Embolism Patients

Catheter-Directed Pulmonary Re Perfusion in Treatment of Intermediate and High Risk Pulmonary Embolism Patients and Its Impact on Pulmonary Artery Pressure

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 safety of such management measured by in-hospital mortality and prevalence of severe adverse events. * Secondary objective: to assess the feasibility of catheter-directed reperfusion in management of intermediate and high risk pulmonary embolism in Assiut University hospital and its reflection on pulmonary artery pressure

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 estimated mortality as high as 30% in high-risk patients . High-risk pulmonary embolism clinically manifests with hemodynamic instability and systemic hypotension (systolic blood pressure \< 90 mm Hg, pressure drop of more than 40 mm Hg or requiring administration of inotropic agents. In this form of PE (pulmonary embolism) imaging studies usually reveal a "saddle embolus" at the bifurcation of the pulmonary trunk, embolism of the main pulmonary artery, or embolic occlusion of at least two lobar arteries. Mortality in high-risk pulmonary embolism is at the level of 60%, and in 66% of these patients fatal outcomes take place during the first hours from the onset of clinical symptoms. The remaining patients with severe pulmonary embolism , those with intermediate risk of mortality, do not reveal hypotension, but present with clinical symptoms comprising dyspnea and/or tachycardia. Estimated 30-day mortality in patients with intermediate risk PE (pulmonary embolism) is at the level of 15-20%, and these patients are at a risk of developing pulmonary hypertension and right ventricle heart failure. Given the fact that 40% of patients with class 4 or 5 of the Pulmonary Embolism Severity Index present with contraindications for systemic fibrinolytic therapy, Catheter-directed reperfusion therapy seems to be a promising alternative treatment modality.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
PROCEDURE	mechanical fragmentation	patients who will be treated with catheter-directed mechanical fragmentation under fluoroscopy guidance. This group will include patients with absolute contraindication for fibrinolytic therapy
PROCEDURE	In Situ thrombolysis	Group (C) will include the patients who will be treated with bed side administration of low dose of local thrombolytic therapy (In Situ) via a trans-Jugular Swan-Ganz pulmonary artery catheter. with guidance of the pressure waveforms obtained from SGC (Swan-Ganz catheter) and echocardiography guidance for ideal Catheter placement. This group will include the patients with relative contraindications for systemic thrombolysis, contraindications for contrasted administration (patients with renal impairment) and also patients with contraindications for radiation exposure (pregnant women).

Timeline

• Start date: 2021-06-30
• Primary completion: 2023-06-30
• Completion: 2023-12-30
• First posted: 2021-06-02
• Last updated: 2021-06-18