NCT04355975

Brief Summary

To investigate safety and effectiveness of PE treatment according to the decision of the multi-disciplinary pulmonary embolism response team (PERT) and to define and optimize treatment indications, institutional algorithms and interventional techniques for PE.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started May 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 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 Progress56%
May 2020Dec 2030

First Submitted

Initial submission to the registry

April 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

10.7 years

First QC Date

April 17, 2020

Last Update Submit

December 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • In-hospital death

    30 days

Secondary Outcomes (4)

  • Peri-procedural adverse events

    30 days

  • Recurrent VTE during follow-up

    up to 5 years

  • Respiratory and functional deterioration after treatment

    6 months

  • Development of chronic thromboembolic pulmonary hypertension (CTEPH)

    up to 5 years

Study Arms (4)

Medical Therapy / Anticoagulation

Systemic Lysis

Interventional Therapy for PE

Surgical Embolectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Patients with Acute PE * Patients developing CTEPH

You may qualify if:

  • Consecutive patients with pulmonary embolism matching the criteria for treatment according to the decision of the PERT.
  • Written informed consent

You may not qualify if:

  • High probability of non-adherence to the follow up requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Bern - Inselspital

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

Related Publications (1)

  • Draxler DF, Johannes JK, Nakase M, Heg D, Dobner S, Turovskij E, Furholz M, Haner J, Lanz J, Pilgrim T, Hunziker L, Praz F, Raber L, Rohla M, Siontis GCM, Susuri-Pfammatter N, Windecker S, Stortecky S. Clinical Outcomes in Patients With Acute Pulmonary Embolism Undergoing Ultrasound-Assisted Catheter-Directed Thrombolysis. J Am Heart Assoc. 2025 May 6;14(9):e035916. doi: 10.1161/JAHA.124.035916. Epub 2025 Apr 25.

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Stefan Stortecky, MD

    Department of Cardiology, Bern University Hospital, University of Bern, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 21, 2020

Study Start

May 1, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

December 15, 2022

Record last verified: 2022-12

Locations