Catheter-interventional Treatment of Pulmonary Embolism

NCT ID: NCT05456789

Last Updated: 2025-03-14

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-16

Study Completion Date

2024-10-10

Brief Summary

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Recent evidence supports the use of catheter-interventional techniques for the treatment of intermediate-high-risk pulmonary embolism. While there is evidence supporting the use of catheter-thrombectomy and alternatively local fibrinolysis, less is known on the combination of both approaches.

The investigators aim to assess the effects of a combined interventional local fibrinolysis and catheter-thrombectomy and to compare them with conventional treatment in a cohort of patients with intermediate-high-risk pulmonary embolism.

Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combined interventional treatment

Combined catheter-based fibrinolysis and thrombectomy plus conventional treatment

Group Type EXPERIMENTAL

combined catheter-thrombectomy and local fibrinolysis

Intervention Type DEVICE

combination of catheter-based thrombectomy with local pulmonary fibrinolysis plus conventional treatment

conventional treatment

Conventional treatment

Group Type ACTIVE_COMPARATOR

conventional treatment

Intervention Type OTHER

conventional treatment of pulmonary embolism

Interventions

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combined catheter-thrombectomy and local fibrinolysis

combination of catheter-based thrombectomy with local pulmonary fibrinolysis plus conventional treatment

Intervention Type DEVICE

conventional treatment

conventional treatment of pulmonary embolism

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* confirmed intermediate high-risk pulmonary embolism
* age \>= 18 years

Exclusion Criteria

* high-risk pulmonary embolism
* contraindications for catheter-based treatment
* known allergy to anticoagulant treatment or fibrinolytics
* pregnancy
* participation in other randomized trials
* patients under legal supervision or guardianship
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart Center Leipzig - University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Heart Center Leipzig at University of Leipzig

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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CATCH-PE

Identifier Type: -

Identifier Source: org_study_id

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