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NCT Number: NCT07003646

Reperfusion Treatment in Acute Pulmonary Embolism

International guidelines recommend immediate reperfusion with systemic thrombolysis (ST) as first-line treatment in high-risk pulmonary embolism (PE). The therapy improves hemodynamics and overall survival but is also associated with a significant risk of severe bleeding. Catheter-directed intervention (CDI) is recommended as an alternative reperfusion therapy in high-risk PE when ST is contraindicated or has failed, as well as in patients who deteriorate or fail to improve during anticoagulation (AC) treatment. Despite lack of high-quality evidence and randomized studies between CDI and standard care, the use of CDI is spreading rapidly in high-risk PE and in less severe PE not fulfilling current treatment criteria.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Denmark

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About this study

Several CDI methods are available, including mechanical thrombectomy (MT) and catheter-directed thrombolysis (CDT), but no method is currently recommended over the other. In Sweden, the MT device FlowTriever® (FT) was introduced in 2021 and has since then been the predominant method. Industry sponsored trials have investigated FT in uncontrolled observational trials and primarily in intermediate-risk PE. The investigator-initiated research on FT is limited to relatively small, descriptive, single-arm studies, or trials focusing on intermediate-risk PE.

There are several ongoing trials comparing different CDI methods to anticoagulation. However, in clinical practice, patients with acute PE may be subjected to different reperfusion strategies depending on severity and available resources. The PE-NORDIC observational study will compare the outcomes of different patient groups treated with current CDI methods used in the Nordic countries to patients treated with ST.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adult patients (≥18 years), including pregnant women, with verified (CTPA, angiography or scintigraphy) acute pulmonary embolism who are planned for, or have received, treatment with catheter directed intervention or systemic thrombolysis
  • Informed consent (for patients who do not survive before informed consent can be obtained, a waiver of consent applies)

Exclusion criteria

  • Ongoing enrolment in interventional catheter directed intervention trial
  • Surgical embolectomy as primary reperfusion treatment

Treatment and study plan

Catheter directed intervention, any device

Procedure

Catheter directed intervention for treatment of pulmonary embolism

alteplase

Drug

Systemic thrombolysis

Primary outcomes

  1. Composite of severe bleeding or mortality at 30 days

    Time frame: From treatment to day 30 after treatment

    A composite of severe bleeding according to GUSTO (defined as intracranial bleeding or bleeding with substantial hemodynamic com-promise requiring treatment) or death within 30 days after treatment

Secondary outcomes

  1. Mortality

    Time frame: 30 days

    Incidence of all-cause mortality

  2. Mortality

    Time frame: 30 days

    Cause of death

  3. Bleeding

    Time frame: 30 days

    Defined by GUSTO criteria, severe/non-severe.

  4. Rescue treatment

    Time frame: 30 days

    Incidence of rescue treatment for PE (Systemic thrombolysis/Catheter-directed intervention/extracorporeal membrane oxygenation (ECMO)/surgical embolectomy)

  5. Recurrent PE

    Time frame: 30 days

    Clinically relevant recurrence of PE

  6. Hospital free days

    Time frame: 30 days

    Hospital free days between treatment and 30 days

  7. ICU/HDU free days

    Time frame: 30 days

    Intensive care unit (ICU) and/or high dependency unit (HDU) free days between treatment and 30 days

  8. Change in RV/LV ratio

    Time frame: 72 hours

    Change in right ventricular to left ventricular (RV/LV) diameter ratio before and within 72 h after treatment.

  9. RV dysfunction

    Time frame: 1 year

    Examined by echocardiogram in association with follow-up visit 1 and 2

  10. Persisting dyspnea

    Time frame: 1 year

    Self-reported level of dyspnea at follow-up visit 1 compared to discharge date and at follow-up visit 2 to compared to visit 1.

  11. 6-minute walk test

    Time frame: 1 year

    Distance (meters) walked in a 6-minute walk test performed at follow-up visit 1 and 2

  12. Sit-to-stand 60 test

    Time frame: 1 year

    Number of stand-ups performed in a sit-to-stand 60 test performed at follow-up visit 1 and 2

  13. PEmb-QoL

    Time frame: 1 year

    Pulmonary Embolism Quality of Life Questionnaire. Disease-specific health-related quality of life.

    FC: Frequency of complaints (8 items, reverse scoring where lower scores correspond to better quality of life).

    AD: Activities of daily living limitations (13 items, reverse scoring where lower scores correspond to better quality of life).

    WR: Work-related problems (4 items, reverse scoring where lower scores correspond to better quality of life).

    SL: Social limitations (1 item).

    IC: Intensity of complaints (2 items).

    EC: Emotional complaints (10 items, reverse scoring where lower scores correspond to better quality of life).

  14. MRC dyspnoea scale

    Time frame: 1 year

    Medical research council dyspnoea scale. 0-4, a higher number corresponds to more dyspnoea.

  15. EQ-5D-5L

    Time frame: 1 year

    EuroQol 5-dimension 5-level questionnaire. Generic health-related quality of life assessment.

    Movement (1-5), 1 corresponds to high and 5 to low movement level (descriptive)

    Care (1-5), 1 corresponds to high and 5 to low care level (descriptive)

    Activity (1-5), 1 corresponds to high and 5 to low activity level (descriptive)

    Pain (1-5), 1 corresponds to low and 5 to high pain level (descriptive)

    Anxiety (1-5), 1 corresponds to low and 5 to high anxiety level (descriptive)

    EQ-VAS (0-100), where 0 corresponds to worst health and 100 to best possible

  16. PVFS scale

    Time frame: 1 year

    Post venous thromboembolism functional status scale (0-4) 0 corresponds to not affected of thromboembolism daily, 4 severely affected in daily life.

  17. Incidence of CTEPH

    Time frame: 1 year

    Incidence of chronic thromboembolic pulmonary hypertension (CTEPH)

  18. Cardiac biomarkers

    Time frame: 1 year

    Troponin and NTproBNP

Study contacts

Contact information is provided by the study sponsor or research team.

Annika Odenstedt, coordinator

CONTACT

[email protected]

+46 343 53 94

Freyr Einarsson, MD

CONTACT

[email protected]

+46500 43 10 36

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Danderyd Hospital
  • Karolinska University Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark
  • Skane University Hospital
  • Stockholm South General Hospital
  • Sunderby Hospital
  • University Hospital, Linkoeping
  • Örebro University, Sweden

Registry information

Official study title

Reperfusion Treatment in Acute Pulmonary Embolism: A Multicenter Observational Study in the Nordic Countries

Acronym: PE-NORDIC

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 4, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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