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Catheter Directed Therapy in Intermediate Risk Pulmonary Embolism Patients

NCT05612854 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-11-10

No results posted yet for this study

Summary

Aim of the work:

1. To compare conventional medical therapy versus catheter-directed therapy in intermediate high risk acute pulmonary embolism.
2. To define predictors of progression from intermediate to high-risk in medically-treated patients for ideal timing for intervention.

Conditions

  • Pulmonary Embolism Subacute Massive

Interventions

PROCEDURE

Mechanical embolectomy: by hydromechanical defragmentation by pigtail

Hydro-mechanical defragmentation (HMD) is one of the CDT modalities for high-risk PE patients, in which rapid pigtail rotation is combined with heparinized saline injection for thrombus fragmentation

DEVICE

Suction embolectomy by the Penumbra Indigo aspiration system

The Penumbra Indigo aspiration system (Penumbra Inc., Alameda, CA, USA) that will be used, is an 8-Fr device and its associated tubing, pump, and separator, has the flexibility for placement in segmental branches of the pulmonary arteries. 510(k) Number :K160449 FOIA Releasable 510(k) K160449 Device Name:Penumbra System, Penumbra Pump MAX

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Shrouk K Ali, MSc · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-30
Primary Completion
2023-12-30
Completion
2024-12-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05612854 on ClinicalTrials.gov