Hemodynamic and Respiratory Instability During Percutaneous Pulmonary Thrombectomy (INSTAB-PE)

Hemodynamic and Respiratory Instability During Percutaneous Pulmonary Thrombectomy in Pulmonary Embolism: Mechanisms, Timing, and Clinical Impact

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Embolism Acute
• Intervention / Treatment: Procedure: Percutaneous Pulmonary Thrombectomy (FlowTriever); Procedure: Percutaneous Pulmonary Thrombectomy (Indigo)

Detailed Description

Pulmonary embolism (PE) is a major cause of cardiovascular morbidity and mortality worldwide and represents the third leading cause of cardiovascular death. Patients with high-risk or intermediate-high-risk PE may develop significant hemodynamic compromise due to acute right ventricular overload and impaired pulmonary circulation. While anticoagulation remains the cornerstone of treatment, reperfusion therapies are recommended in selected patients, including systemic thrombolysis, catheter-directed therapies, and surgical embolectomy.

Percutaneous pulmonary thrombectomy has emerged as an increasingly used reperfusion strategy, particularly in patients with contraindications to thrombolysis or in whom rapid hemodynamic improvement is required. Despite its growing use, the intraprocedural course of these patients is not fully understood. During thrombectomy, mechanical manipulation within the pulmonary arteries, transient increases in pulmonary vascular resistance, and the effects of anesthesia and positive pressure ventilation may contribute to hemodynamic and respiratory instability. These complications may manifest as hypotension, shock, hypoxemia, need for vasopressor support, endotracheal intubation, cardiopulmonary resuscitation, or the requirement for extracorporeal membrane oxygenation (ECMO).

Currently, there is limited evidence regarding the incidence, timing, and underlying mechanisms of intraprocedural hemodynamic and respiratory deterioration during percutaneous pulmonary thrombectomy. In addition, the potential influence of procedural factors, such as the type of thrombectomy device used, has not been fully elucidated. The FlowTriever® (Inari Medical) and Indigo® (Penumbra) systems are among the most commonly used devices, yet comparative data regarding their safety profiles in terms of intraprocedural instability are scarce.

Furthermore, biomarkers reflecting right ventricular strain, such as N-terminal pro-B-type natriuretic peptide (NT-proBNP), may provide prognostic information in acute PE. However, their role in predicting intraprocedural instability during thrombectomy remains unclear and warrants further investigation.

This prospective observational study aims to comprehensively evaluate 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 primary outcome is a composite of intraprocedural events including significant hypotension, escalation of vasopressor support, need for mechanical ventilation or intubation, cardiopulmonary resuscitation, and/or initiation of ECMO. The temporal relationship between instability and different procedural phases will also be analyzed.

In addition, the study will compare the incidence of intraprocedural instability between patients treated with different thrombectomy devices (FlowTriever® versus Indigo®), adjusting for baseline risk stratification. Secondary objectives include evaluating the prognostic value of baseline NT-proBNP levels for predicting intraprocedural instability and assessing in-hospital and 30-day mortality and their underlying causes.

By providing a detailed characterization of intraprocedural instability and its determinants, this study aims to improve risk stratification, optimize procedural planning, and guide clinical decision-making in patients undergoing percutaneous pulmonary thrombectomy. Ultimately, these findings may contribute to improving patient safety and clinical outcomes in this high-risk population.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Susana González Suárez, MD; PhD; Phone Number: +34 934894092; Email: susana.gonzalez@vallhebron.cat

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Vall d'Hebron Research Institute (VHIR)
    • Contact: Susana González Suárez, MD, PhD; Phone Number: 934894092; Email: susana.gonzalez@vallhebron.cat
    • Contact: Susana González Suárez, MD, PhD; Phone Number: +34 934894092; Email: susana.gonzalez@vallhebron.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic Value of Baseline NT-proBNP for Intraprocedural Instability	Association between baseline NT-proBNP levels measured prior to the procedure and the occurrence of intraprocedural hemodynamic and/or respiratory instability.	Baseline (pre-procedure) and during the procedure
In-hospital and 30-day Mortality	All-cause mortality during hospitalization and within 30 days after the procedure, including analysis of underlying causes.	Up to 30 days after the procedure

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): April 10, 2030
• Study Completion (Estimated): May 10, 2030

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Shock; Pulmonary Embolism; NT-proBNP; Hemodynamic Instability; Percutaneous Pulmonary Thrombectomy; Catheter-Directed Thrombectomy; Respiratory Instability
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pathological Conditions, Signs and Symptoms; Pulmonary Embolism; Shock; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indigo Carmine
• Other Study ID Numbers: PR(AG)367/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to institutional data protection policies and patient confidentiality considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No