Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07885787

Post Pulmonary Embolism In Patients Treated With Catheter Based Therapy

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

Comparing the effects of the mechanical thrombectomy versus medical treatment alone on development and severity of post pulmonary embolism syndrome. To define predictors of post pulmonary embolism syndrome. Incidence of category D and category E pulmonary embolism among P.E patients presenting by hemodynamic compromise. Correlation with NEWS risk score (Respiratory rate, oxygen saturation, temperature, systolic blood pressure, heart rate, level of consciousness, and need for supplemental oxygen).

Official title: Post Pulmonary Embolism Functional Status And Quality Of Life In Patients Treated With Catheter Based Therapy

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-12-01

Completion Date

2029-12-30

Last Updated

2026-10-21

Healthy Volunteers

Conditions

Pulmonary Embolism Acute

Interventions

DEVICE

The Indigo aspiration system

The Indigo aspiration system (Indigo Aspiration 8-16-F ® System, Penumbra, Alameda, CA, USA) is indicated for use in the peripheral arterial system and the pulmonary arteries, receiving U.S. Food and Drug Administration clearance for PE in December 2019. The PA will be accessed percutaneously, and a diagnostic pulmonary angiogram will be performed to evaluate hemodynamics. The aspiration catheter will be introduced over a 0.035-inch guidewire and advanced to the right or left PA, proximal to the thrombus. Once proximal to the occlusive thrombus, the physician will initiate sustained aspiration with the pump. If appropriate, the separator will be advanced through the catheter to assist with clearing the catheter lumen. Aspiration could be repeated in multiple pulmonary vessels with or without thrombus removal and flushing the catheter between passes. A final pulmonary angiogram and hemodynamic evaluation will be conducted post-Indigo device removal and post procedure

Inclusion Criteria: * Age 18-80 years old. * Clinical signs and symptoms consistent with acute PE with duration of 14 days or less. * Objectively confirmed acute PE, based on CTPA imaging showing a filling defect in at least one main or proximal lobar pulmonary artery. * Category E patients according to AHA recent guidelines for management of P.E including patients with cardiopulmonary failure states (either cardiac arrest, refractory cardiogenic shock or recurrent or persistent hypotension with cardiogenic shock). * Category D patients (i.e patients with incipient cardiopulmonary failure) including normotensive shock with marker of decreased perfusion or end-organ dysfunction (eg, acute ischemic kidney injury, persistently elevated lactate) accompanied by transient hypotension and patients with transient or recurrent hypotension (including relative hypotension compared with the patient's baseline blood pressure) that is short-lived or responds to volume expansion and not accompanied by any signs of reduced perfusion or end-organ dysfunction. * Category C2,C3 patients with symptomatic disease with increased risk of adverse outcomes by validated severity index and either abnormal RV or abnormal cardiac biomarkers or both. * Femoral access deemed suitable for mechanical thrombectomy. * Informed consent is obtained from either the patient or legally authorized representative. Exclusion Criteria: * Category A patients including asymptomatic and incidentally diagnosed PE cases. * Category B patients with symptomatic acute PE and low risk of adverse outcomes by validated severity indices. * Category C1 patients with symptomatic disease with increased risk of adverse outcomes by validated severity index with normal RV and normal cardiac biomarkers. * History or imaging findings consistent with CTEPH or CTEPD diagnosis. * Any known contraindication to anticoagulation including allergy, hypersensitivity, or heparin induced thrombocytopenia. * Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated. * Active bleeding or disorders contraindicating anticoagulant therapy. * Platelets \<50,000/µL.

Locations (1)

Assiut university heart hospital

Asyut, Egypt