Hemodynamic and Respiratory Instability During Percutaneous Pulmonary Thrombectomy

NCT07509541 | Not Yet Recruiting

• 1 other identifier: PR(AG)367/2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary embolism (PE) is a potentially life-threatening condition caused by the obstruction of pulmonary arteries by thrombi. Patients with high-risk or intermediate-high-risk PE may require immediate reperfusion therapies, including percutaneous pulmonary thrombectomy. However, this procedure can be associated with significant hemodynamic and respiratory instability, potentially leading to shock, cardiac arrest, or the need for advanced support such as mechanical ventilation or extracorporeal membrane oxygenation (ECMO). The mechanisms, timing, and causes of intraprocedural hemodynamic and respiratory deterioration during pulmonary thrombectomy are not well established. Factors such as catheter manipulation within the pulmonary arteries, increased pulmonary pressures, and the effects of anesthesia and mechanical ventilation may contribute to clinical instability. In addition, biomarkers such as NT-proBNP may reflect right ventricular strain and could help predict the risk of instability during the procedure. The aim of this prospective observational study is to determine the incidence, causes, and timing of hemodynamic and/or respiratory instability during percutaneous pulmonary thrombectomy in patients with high-risk or intermediate-high-risk PE. The study will also compare the occurrence of instability between different thrombectomy devices (FlowTriever® and Indigo® systems) and evaluate the prognostic role of baseline NT-proBNP levels. Secondary objectives include the assessment of in-hospital and 30-day mortality and their underlying causes. This study will include adult patients undergoing percutaneous pulmonary thrombectomy as part of routine clinical care. The results of this study may help improve risk stratification, guide procedural planning, and optimize the management of patients undergoing pulmonary thrombectomy, ultimately aiming to reduce morbidity and mortality.

Conditions

Pulmonary Embolism Acute

Keywords

Pulmonary Embolism; Percutaneous Pulmonary Thrombectomy; Catheter-Directed Thrombectomy; Hemodynamic Instability; Respiratory Instability; Shock; NT-proBNP

Outcome Measures

Primary Outcomes (1)

• Intraprocedural Hemodynamic and/or Respiratory Instability

  Composite outcome defined as the occurrence of any of the following events during percutaneous pulmonary thrombectomy: sustained hypotension (systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg for ≥15 minutes), initiation or escalation of vasopressor support, cardiopulmonary resuscitation, need for extracorporeal membrane oxygenation (ECMO), oxygen saturation \<90% sustained, escalation of ventilatory support, or need for endotracheal intubation. Events will also be analyzed according to procedural timing.

  During the percutaneous pulmonary thrombectomy procedure

Secondary Outcomes (2)

• Prognostic Value of Baseline NT-proBNP for Intraprocedural Instability

  Baseline (pre-procedure) and during the procedure

• In-hospital and 30-day Mortality

  Up to 30 days after the procedure

Study Arms (2)

FlowTriever Group

Patients with pulmonary embolism undergoing percutaneous pulmonary thrombectomy using the FlowTriever system as part of routine clinical care. Device selection is based on physician discretion.

Procedure: Percutaneous Pulmonary Thrombectomy (FlowTriever)

Indigo Group

Patients with pulmonary embolism undergoing percutaneous pulmonary thrombectomy using the Indigo system as part of routine clinical care. Device selection is based on physician discretion.

Procedure: Percutaneous Pulmonary Thrombectomy (Indigo)

Interventions

Percutaneous Pulmonary Thrombectomy (FlowTriever) PROCEDURE

Percutaneous pulmonary thrombectomy performed using the FlowTriever system as part of routine clinical care. Device selection is based on physician discretion and not assigned by the study protocol.

FlowTriever Group

Percutaneous Pulmonary Thrombectomy (Indigo) PROCEDURE

Percutaneous pulmonary thrombectomy performed using the Indigo system as part of routine clinical care. Device selection is based on physician discretion and not assigned by the study protocol.

Indigo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with high-risk or intermediate-high-risk pulmonary embolism undergoing percutaneous pulmonary thrombectomy in routine clinical practice.

You may qualify if:

• Patients (aged ≥18 years) with high-risk or intermediate-high-risk pulmonary embolism
• Patients undergoing percutaneous pulmonary thrombectomy as part of routine clinical care

You may not qualify if:

• Age \<18 years
• Low-risk pulmonary embolism
• Patients not undergoing percutaneous pulmonary thrombectomy
• Patients presenting with refractory shock upon arrival to the interventional suite

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Vall d'Hebron Research Institute (VHIR)

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Pulmonary Embolism; Shock

Interventions

Indigo Carmine

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Susana González Suárez, MD; PhD

CONTACT

+34 934894092; susana.gonzalez@vallhebron.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 3, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): April 10, 2030
• Study Completion (Estimated): May 10, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)