Pulmonary EmbolismPE-NORDICNCT07003646
Reperfusion Treatment in Acute Pulmonary Embolism
An observational study of Pulmonary Embolism, run by Sahlgrenska University Hospital at 13 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Catheter directed intervention, any device and Alteplase
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 220 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 1 Apr 2025to 1 May 2029
- 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: Pulmonary embolism patients treated with catheter directed intervention or systemtic thrombolysis in hospitals in Sweden and Denmark where the former treatment modality is established.
Who may be able to join
- 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)
Who cannot join
- Ongoing enrolment in interventional catheter directed intervention trial
- Surgical embolectomy as primary reperfusion treatment
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
Sweden10 sites, 10 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 41345
Annika Odenstedt, coordinator, +46 31 343 5394, annika.odenstedt@vgregion.se
Katarina Glise Sandblad, PhD
- Recruiting
Linköping University Hospital
Linköping
Margareta Holmström, Prof, +4610-103 00 00, margareta.holmstrom@liu.se
Margareta Holmström, Prof
- Recruiting
Sunderby Hospital
Luleå
Nils Witt, PhD, +46920-28 20 00, nils.witt@norrbotten.se
Nils Witt, PhD
- Recruiting
Skåne University Hospital
Lund
Johan Elf, +4640-33 10 00, johan.elf@skane.se
Johan Elf
- Recruiting
Örebro University Hospital
Örebro
Annika Eriksson, +46196021000, annika.eriksson@regionorebrolan.se
Fredrik Calais, PhD
- Recruiting
Danderyd Hospital
Stockholm
Eli Westerlund, PhD, +468-123 550 00, eli.westerlund@ki.se
Eli Westerlund, PhD
- Recruiting
Karolinska University Hospital Huddinge
Stockholm
Therese Djärv, Prof, +468-123 800 00, therese.djarv@ki.se
Therese Djärv, Prof
- Recruiting
Karolinska University Hospital Solna
Stockholm
Therese Djärv, Prof, +468-123 700 00, therese.djarv@ki.se
Therese Djärv, Prof
- Recruiting
Södersjukhuset
Stockholm
Mårten Söderberg, PhD, +468-123 610 00, marten.soderberg@regionstockholm.se
Mårten Söderberg, PhD
- Not yet recruiting
Uppsala University Hospital
Uppsala
Christian Rylander, Prof, +4618-611 00 00, christian.rylander@surgsci.uu.se
Christian Rylander, Prof
Denmark3 sites, 3 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
Elisa Stilling, +45 78 45 00 00, elisstil@rm.dk
Asger Andersen, Prof
- Recruiting
Rigshospitalet
Copenhagen
Jesper Kjærgaard, +45 35 45 35 45, jesper.kjaergaard.05@regionh.dk
Jesper Kjærgaard
- Recruiting
Odense University Hospital
Odense
Gro Egholm, PhD, +45 66 11 33 33, gro.egholm@rsyd.dk
Gro Egholm, PhD
About this study
Official title: Reperfusion Treatment in Acute Pulmonary Embolism: A Multicenter Observational Study in the Nordic Countries
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.
Read the detailed description
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
- Pulmonary Embolism
- Being tested
- Catheter directed intervention, any device, Alteplase
- Keywords
- Thrombolysis, Catheter-directed intervention, Aspirational thrombectomy, Catheter-directed tromboylsis, High-risk PE
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter directed intervention, any deviceProcedure or surgery
Catheter directed intervention for treatment of pulmonary embolism
AlteplaseDrug
Systemic thrombolysis
| Study group | Role | What they receive |
|---|---|---|
| Catheter-directed intervention | Catheter-directed intervention, any device Receives: Procedure: Catheter directed intervention, any device | |
| Systemic thrombolysis | Intravenous thrombolysis with tissue-type plasminogen activator (tPA) Receives: Drug: Alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of severe bleeding or mortality at 30 days
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
Measured: From treatment to day 30 after treatment
Secondary outcomes (18)
Mortality
Incidence of all-cause mortality
Measured: 30 days
Mortality
Cause of death
Measured: 30 days
Bleeding
Defined by GUSTO criteria, severe/non-severe.
Measured: 30 days
Rescue treatment
Incidence of rescue treatment for PE (Systemic thrombolysis/Catheter-directed intervention/extracorporeal membrane oxygenation (ECMO)/surgical embolectomy)
Measured: 30 days
Recurrent PE
Clinically relevant recurrence of PE
Measured: 30 days
Hospital free days
Hospital free days between treatment and 30 days
Measured: 30 days
ICU/HDU free days
Intensive care unit (ICU) and/or high dependency unit (HDU) free days between treatment and 30 days
Measured: 30 days
Change in RV/LV ratio
Change in right ventricular to left ventricular (RV/LV) diameter ratio before and within 72 h after treatment.
Measured: 72 hours
RV dysfunction
Examined by echocardiogram in association with follow-up visit 1 and 2
Measured: 1 year
Persisting dyspnea
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.
Measured: 1 year
6-minute walk test
Distance (meters) walked in a 6-minute walk test performed at follow-up visit 1 and 2
Measured: 1 year
Sit-to-stand 60 test
Number of stand-ups performed in a sit-to-stand 60 test performed at follow-up visit 1 and 2
Measured: 1 year
PEmb-QoL
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).
Measured: 1 year
MRC dyspnoea scale
Medical research council dyspnoea scale. 0-4, a higher number corresponds to more dyspnoea.
Measured: 1 year
EQ-5D-5L
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
Measured: 1 year
PVFS scale
Post venous thromboembolism functional status scale (0-4) 0 corresponds to not affected of thromboembolism daily, 4 severely affected in daily life.
Measured: 1 year
Incidence of CTEPH
Incidence of chronic thromboembolic pulmonary hypertension (CTEPH)
Measured: 1 year
Cardiac biomarkers
Troponin and NTproBNP
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Apr 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital, Karolinska University Hospital, Danderyd Hospital, University Hospital, Linkoeping, Sunderby Hospital, Aarhus University Hospital, Örebro University, Sweden, Odense University Hospital, Skane University Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Kristina Svennerholm, Sahlgrenska University Hospital
- Investigators
- Kristina Svennerholm, Assoc Prof, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003646
- Sponsor's protocol ID
- PE-NORDIC
- Acronym
- PE-NORDIC
- Status last verified
- Jan 2026
- First submitted
- 16 May 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Einarsson Askeli F, Andersen A, Glise Sandblad K, Martinell L, Pivodic A, Rylander C, Tavoly M, Svennerholm K; PE-NORDIC Investigators. Reperfusion treatment strategies in acute pulmonary embolism: Study protocol for a multicenter prospective observational study in the Nordic countries (PE-NORDIC). Thromb Res. 2026 Apr;260:109635. doi: 10.1016/j.thromres.2026.109635. Epub 2026 Mar 3.
PubMed 41812431
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reperfusion Treatment in Acute Pulmonary Embolism: A Multicenter Observational Study in the Nordic Countries
- ClinicalTrials.gov ID
- NCT07003646
- Acronym / sponsor ID
- PE-NORDIC / PE-NORDIC
- Conditions
- Pulmonary Embolism
- Keywords
- Thrombolysis, Catheter-directed intervention, Aspirational thrombectomy, Catheter-directed tromboylsis, High-risk PE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital, Karolinska University Hospital, Danderyd Hospital, University Hospital, Linkoeping, Sunderby Hospital, Aarhus University Hospital, Örebro University, Sweden, Odense University Hospital, Skane University Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 4 Jun 2025 (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.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter-directed intervention | – | Procedure: Catheter directed intervention, any deviceCatheter-directed intervention, any device |
| Systemic thrombolysis | – | Drug: AlteplaseIntravenous thrombolysis with tissue-type plasminogen activator (tPA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pulmonary embolism patients treated with catheter directed intervention or systemtic thrombolysis in hospitals in Sweden and Denmark where the former treatment modality is established.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Ongoing enrolment in interventional catheter directed intervention trial
- Surgical embolectomy as primary reperfusion treatment
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 |
|---|---|---|
| Catheter directed intervention, any deviceCatheter directed intervention for treatment of pulmonary embolism | Procedure or surgery | Catheter-directed intervention |
| AlteplaseSystemic thrombolysis | Drug | Systemic thrombolysis |
Primary outcome
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
18 secondary outcomes
Mortality
Time frame: 30 days
Mortality
Time frame: 30 days
Bleeding
Time frame: 30 days
Rescue treatment
Time frame: 30 days
Recurrent PE
Time frame: 30 days
Hospital free days
Time frame: 30 days
ICU/HDU free days
Time frame: 30 days
Change in RV/LV ratio
Time frame: 72 hours
RV dysfunction
Time frame: 1 year
Persisting dyspnea
Time frame: 1 year
6-minute walk test
Time frame: 1 year
Sit-to-stand 60 test
Time frame: 1 year
PEmb-QoL
Time frame: 1 year
MRC dyspnoea scale
Time frame: 1 year
EQ-5D-5L
Time frame: 1 year
PVFS scale
Time frame: 1 year
Incidence of CTEPH
Time frame: 1 year
Cardiac biomarkers
Time frame: 1 year
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 21 Jan 2026.
- Derived from this study: PubMed 41812431Einarsson Askeli F, Andersen A, Glise Sandblad K, Martinell L, Pivodic A, Rylander C, Tavoly M, Svennerholm K; PE-NORDIC Investigators. Reperfusion treatment strategies in acute pulmonary embolism: Study protocol for a multicenter prospective observational study in the Nordic countries (PE-NORDIC). Thromb Res. 2026 Apr;260:109635. doi: 10.1016/j.thromres.2026.109635. Epub 2026 Mar 3.
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
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.
Kristina Svennerholm, Assoc Prof principal investigator
Sahlgrenska University Hospital
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Sahlgrenska University Hospital at 13 sites in 2 countries.
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 2 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Sweden, Denmark. 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 Freyr Einarsson, MD (+46500 43 10 36, freyr.einarsson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of severe bleeding or mortality at 30 days (time frame: From treatment to day 30 after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07003646, which also lists 1 linked publication.
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 21 Jan 2026.