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Recruiting NCT07003646

NCT07003646 Reperfusion Treatment in Acute Pulmonary Embolism

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Clinical Trial Summary
NCT ID NCT07003646
Status Recruiting
Phase —
Sponsor Sahlgrenska University Hospital
Condition Pulmonary Embolism
Study Type OBSERVATIONAL
Enrollment 220 participants
Start Date 2025-04-01
Primary Completion 2028-05-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Catheter directed intervention, any deviceAlteplase

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 220 participants in total. It began in 2025-04-01 with a primary completion date of 2028-05-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Freyr Einarsson, MD

✉ freyr.einarsson@vgregion.se

📞 +46500 43 10 36

Principal Investigator

Kristina Svennerholm, Assoc Prof

PRINCIPAL INVESTIGATOR

Sahlgrenska University Hospital

Frequently Asked Questions

Who can join the NCT07003646 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Embolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07003646 currently recruiting?

Yes, NCT07003646 is actively recruiting participants. Contact the research team at freyr.einarsson@vgregion.se for enrollment information.

Where is the NCT07003646 trial being conducted?

This trial is being conducted at Aarhus, Denmark, Copenhagen, Denmark, Odense, Denmark, Gothenburg, Sweden and 9 additional locations.

Who is sponsoring the NCT07003646 clinical trial?

NCT07003646 is sponsored by Sahlgrenska University Hospital. The principal investigator is Kristina Svennerholm, Assoc Prof at Sahlgrenska University Hospital. The trial plans to enroll 220 participants.

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