Reperfusion Treatment in Acute Pulmonary Embolism

NCT ID: NCT07003646

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2029-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Catheter-directed intervention

Catheter-directed intervention, any device

Catheter directed intervention, any device

Intervention Type PROCEDURE

Catheter directed intervention for treatment of pulmonary embolism

Systemic thrombolysis

Intravenous thrombolysis with tissue-type plasminogen activator (tPA)

Alteplase

Intervention Type DRUG

Systemic thrombolysis

Interventions

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Catheter directed intervention, any device

Catheter directed intervention for treatment of pulmonary embolism

Intervention Type PROCEDURE

Alteplase

Systemic thrombolysis

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stockholm South General Hospital

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Danderyd Hospital

OTHER

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role collaborator

Sunderby Hospital

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Örebro University, Sweden

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Skane University Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kristina Svennerholm

Principal investigator. MD. PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristina Svennerholm, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Linköping University Hospital

Linköping, , Sweden

Site Status RECRUITING

Sunderby Hospital

Luleå, , Sweden

Site Status RECRUITING

Skåne University Hospital

Lund, , Sweden

Site Status RECRUITING

Örebro University Hospital

Örebro, , Sweden

Site Status RECRUITING

Danderyd Hospital

Stockholm, , Sweden

Site Status RECRUITING

Karolinska University Hospital Huddinge

Stockholm, , Sweden

Site Status RECRUITING

Karolinska University Hospital Solna

Stockholm, , Sweden

Site Status RECRUITING

Södersjukhuset

Stockholm, , Sweden

Site Status RECRUITING

Uppsala University Hospital

Uppsala, , Sweden

Site Status NOT_YET_RECRUITING

Countries

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Denmark Sweden

Central Contacts

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Freyr Einarsson, MD

Role: CONTACT

+46500 43 10 36

Annika Odenstedt, coordinator

Role: CONTACT

+46 343 53 94

Facility Contacts

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Elisa Stilling

Role: primary

+45 78 45 00 00

Jesper Kjærgaard

Role: primary

+45 35 45 35 45

Gro Egholm, PhD

Role: primary

+45 66 11 33 33

Annika Odenstedt, coordinator

Role: primary

+46 31 343 5394

Margareta Holmström, Prof

Role: primary

+4610-103 00 00

Nils Witt, PhD

Role: primary

+46920-28 20 00

Johan Elf

Role: primary

+4640-33 10 00

Annika Eriksson

Role: primary

+46196021000

Eli Westerlund, PhD

Role: primary

+468-123 550 00

Therese Djärv, Prof

Role: primary

+468-123 800 00

Therese Djärv, Prof

Role: primary

+468-123 700 00

Mårten Söderberg, PhD

Role: primary

+468-123 610 00

Christian Rylander, Prof

Role: primary

+4618-611 00 00

Other Identifiers

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PE-NORDIC

Identifier Type: -

Identifier Source: org_study_id

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