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NCT07509541: INSTAB-PE
Hemodynamic and Respiratory Instability During Percutaneous Pulmonary Thrombectomy
trial testing Percutaneous Pulmonary Thrombectomy (FlowTriever) in Pulmonary Embolism Acute in 100 participants. Not yet recruiting.
10 April 2030
Quick facts
| Lead sponsor | Hospital Universitari Vall d'Hebron Research Institute |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 10 April 2026 |
| Primary completion | 10 April 2030 |
| Estimated completion | 10 May 2030 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Percutaneous Pulmonary Thrombectomy (FlowTriever)
- Percutaneous Pulmonary Thrombectomy (Indigo)
Conditions studied
- Pulmonary Embolism Acute — all drugs for Pulmonary Embolism Acute →
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Who can join
18 and older, any sex, with Pulmonary Embolism Acute. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07509541
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pulmonary Embolism Acute
Currently open trials in the same condition.
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- NCT07029841 — Cohort Study on Treatment Comes of Catheter-based Therapy in Patients With Acute Pulmonary Embolism in Hong Kong · recruiting
- NCT06348459 — Registry of Catheter Intervention in Pulmonary Embolism · recruiting
Other Hospital Universitari Vall d'Hebron Research Institute trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07509541 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute
- Last refreshed: 3 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07509541.
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