NCT07003646

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started Apr 2025

Longer than P75 for all trials

Geographic Reach
2 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Apr 2025May 2029

Study Start

First participant enrolled

April 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

May 16, 2025

Last Update Submit

January 18, 2026

Conditions

Pulmonary Embolism

Keywords

ThrombolysisCatheter-directed interventionAspirational thrombectomyCatheter-directed tromboylsisHigh-risk PE

Outcome Measures

Primary Outcomes (1)

  • 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

    From treatment to day 30 after treatment

Secondary Outcomes (18)

  • Mortality

    30 days

  • Mortality

    30 days

  • Bleeding

    30 days

  • Rescue treatment

    30 days

  • Recurrent PE

    30 days

  • +13 more secondary outcomes

Study Arms (2)

Catheter-directed intervention

Catheter-directed intervention, any device

Procedure: Catheter directed intervention, any device

Systemic thrombolysis

Intravenous thrombolysis with tissue-type plasminogen activator (tPA)

Drug: Alteplase

Interventions

Catheter directed intervention, any devicePROCEDURE

Catheter directed intervention for treatment of pulmonary embolism

Catheter-directed intervention
AlteplaseDRUG

Systemic thrombolysis

Systemic thrombolysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

Linköping University Hospital

Linköping, Sweden

RECRUITING

Sunderby Hospital

Luleå, Sweden

RECRUITING

Skåne University Hospital

Lund, Sweden

RECRUITING

Örebro University Hospital

Örebro, Sweden

RECRUITING

Danderyd Hospital

Stockholm, Sweden

RECRUITING

Karolinska University Hospital Huddinge

Stockholm, Sweden

RECRUITING

Karolinska University Hospital Solna

Stockholm, Sweden

RECRUITING

Södersjukhuset

Stockholm, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Officials

  • Kristina Svennerholm, Assoc Prof

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Freyr Einarsson, MD

CONTACT

+46500 43 10 36freyr.einarsson@vgregion.se

Annika Odenstedt, coordinator

CONTACT

+46 343 53 94annika.odenstedt@vgregion.se

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator. MD. PhD.

Study Record Dates

First Submitted

May 16, 2025

First Posted

June 4, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2029

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

DK(3)SE(10)