Systemic Thrombolysis Versus Catheter Directed Management for Acute Intermediate-high Pulmonary Embolism

N/ANot Yet RecruitingNCT06545864

Assiut University50 enrolled

Overview

To compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Pulmonary Embolism

Interventions

Streptokinase InjectionDRUG

250000 IU as a loading dose over 30 min. Followed by 100000 IU/hour over 12:24hours or accelerated regimen 1.5 million IU over 2 hours

Penumbra SystemDEVICE

which comprised of several devices: * RED Reperfusion Catheters * Penumbra JET Reperfusion Catheters * ACE Reperfusion Catheters * MAX Reperfusion Catheters * 3D Revascularization Device * Penumbra ENGINE Aspiration Source * Penumbra ENGINE Canister * Aspiration Tubing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients diagnosed with acute intermediate-high pulmonary embolism Exclusion Criteria: * Patients less than 18 years of age. * Low risk, intermediate low risk, acute pulmonary embolism * patients with RV masses will be excluded. * Patient refusal of treatment strategy.

Locations (1)

Hospital University

Asyut, Egypt

Outcomes

Primary Outcomes

Change in blood pressure

Time frame: during hospital stay (about 1 week) and one month after discharge

Change in heart rate

Time frame: during hospital stay (about 1 week) and one month after discharge

Change in respiratory rate

Time frame: during hospital stay (about 1 week) and one month after discharge

Change of O2 saturation.