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Systemic Thrombolysis Versus Catheter Directed Management for Acute Intermediate-high Pulmonary Embolism

NCT06545864 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-08-09

No results posted yet for this study

Summary

To compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System).

Conditions

  • Acute Pulmonary Embolism

Interventions

DRUG

Streptokinase Injection

250000 IU as a loading dose over 30 min. Followed by 100000 IU/hour over 12:24hours or accelerated regimen 1.5 million IU over 2 hours

DEVICE

Penumbra System

which comprised of several devices: * RED Reperfusion Catheters * Penumbra JET Reperfusion Catheters * ACE Reperfusion Catheters * MAX Reperfusion Catheters * 3D Revascularization Device * Penumbra ENGINE Aspiration Source * Penumbra ENGINE Canister * Aspiration Tubing

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Ayman K Mohamed, PHD · Assiut University

  • Mohamed O Abdelhameed, master · Assiut University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2029-11-30
Completion
2030-03-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • Egypt

Study Locations

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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 NCT06545864 on ClinicalTrials.gov