Pulmonary Embolism AcuteINSTAB-PENCT07509541
Hemodynamic and Respiratory Instability During Percutaneous Pulmonary Thrombectomy
An observational study of Pulmonary Embolism Acute, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism Acute
- What is being tested?
- Percutaneous Pulmonary Thrombectomy (FlowTriever) and Percutaneous Pulmonary Thrombectomy (Indigo)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 10 Apr 2026to 10 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with high-risk or intermediate-high-risk pulmonary embolism undergoing percutaneous pulmonary thrombectomy in routine clinical practice.
Who may be able to join
- Patients (aged ≥18 years) with high-risk or intermediate-high-risk pulmonary embolism
- Patients undergoing percutaneous pulmonary thrombectomy as part of routine clinical care
Who cannot join
- Age <18 years
- Low-risk pulmonary embolism
- Patients not undergoing percutaneous pulmonary thrombectomy
- Patients presenting with refractory shock upon arrival to the interventional suite
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Vall d'Hebron Research Institute (VHIR)
Barcelona, 08035
Susana González Suárez, MD, PhD, 934894092, susana.gonzalez@vallhebron.cat
Susana González Suárez, MD, PhD, +34 934894092, susana.gonzalez@vallhebron.cat
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pulmonary Embolism Acute
- Being tested
- Percutaneous Pulmonary Thrombectomy (FlowTriever), Percutaneous Pulmonary Thrombectomy (Indigo)
- Keywords
- Pulmonary Embolism, Percutaneous Pulmonary Thrombectomy, Catheter-Directed Thrombectomy, Hemodynamic Instability, Respiratory Instability, Shock, NT-proBNP
- Medical subject headings
- Pulmonary Embolism, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Pulmonary Thrombectomy (FlowTriever)Procedure or surgery
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.
Percutaneous Pulmonary Thrombectomy (Indigo)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Percutaneous Pulmonary Thrombectomy (Indigo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the percutaneous pulmonary thrombectomy procedure
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion10 Apr 2030 (estimated)
- Study completion10 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism AcuteStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509541
- Sponsor's protocol ID
- PR(AG)367/2025
- Acronym
- INSTAB-PE
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data protection policies and patient confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic and Respiratory Instability During Percutaneous Pulmonary Thrombectomy in Pulmonary Embolism: Mechanisms, Timing, and Clinical Impact
- ClinicalTrials.gov ID
- NCT07509541
- Acronym / sponsor ID
- INSTAB-PE / PR(AG)367/2025
- Conditions
- Pulmonary Embolism Acute
- Keywords
- Pulmonary Embolism, Percutaneous Pulmonary Thrombectomy, Catheter-Directed Thrombectomy, Hemodynamic Instability, Respiratory Instability, Shock, NT-proBNP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 10 Apr 2030 (estimated)
- Study completion
- 10 May 2030 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FlowTriever Group | – | Procedure: Percutaneous Pulmonary Thrombectomy (FlowTriever)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. |
| Indigo Group | – | Procedure: Percutaneous Pulmonary Thrombectomy (Indigo)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with high-risk or intermediate-high-risk pulmonary embolism undergoing percutaneous pulmonary thrombectomy in routine clinical practice.
Key inclusion criteria (2 listed)
- Patients (aged ≥18 years) with high-risk or intermediate-high-risk pulmonary embolism
- Patients undergoing percutaneous pulmonary thrombectomy as part of routine clinical care
Key exclusion criteria (4 listed)
- Age <18 years
- Low-risk pulmonary embolism
- Patients not undergoing percutaneous pulmonary thrombectomy
- Patients presenting with refractory shock upon arrival to the interventional suite
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | FlowTriever Group |
| 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. | Procedure or surgery | Indigo Group |
Primary outcome
Intraprocedural Hemodynamic and/or Respiratory Instability
Time frame: During the percutaneous pulmonary thrombectomy procedure
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.
2 secondary outcomes
Prognostic Value of Baseline NT-proBNP for Intraprocedural Instability
Time frame: Baseline (pre-procedure) and during the procedure
In-hospital and 30-day Mortality
Time frame: Up to 30 days after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data protection policies and patient confidentiality considerations.
Related trials for Pulmonary Embolism Acute
Not yet recruiting
CTEPH Differential Diagnosis Assisted by Enhanced Large Language Model Support
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)
Not yet recruitingPhase 4
Reduced-Dose Versus Full-Dose Alteplase for High-Risk Pulmonary Embolism
Pulmonary Embolism Acute
RecruitingObservational study
A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism
Acute Pulmonary Embolism
Not yet recruiting
Post Pulmonary Embolism In Patients Treated With Catheter Based Therapy
Pulmonary Embolism Acute
Not yet recruitingObservational study
Cardiovascular Risk in Patients With IBD
Ulcerative Colitis (UC), Crohn's Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism Acute, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susana González Suárez, MD; PhD (+34 934894092, susana.gonzalez@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraprocedural Hemodynamic and/or Respiratory Instability (time frame: During the percutaneous pulmonary thrombectomy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.