Catheter Directed Therapy in Intermediate Risk Pulmonary Embolism Patients

NCT05612854 | Unknown Early Phase 1 FDA Device

• 1 other identifier: CDT in pulmonary embolism
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim of the work:

1. 1.To compare conventional medical therapy versus catheter-directed therapy in intermediate high risk acute pulmonary embolism.
2. 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

Keywords

catheter directed therapy; intermediate risk pulmonary embolism

Outcome Measures

Primary Outcomes (3)

• 1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients

  comparison in intermediate high risk acute pulmonary embolism patients between conventional medical therapy and catheter-directed therapy as regarding safety and efficacy of the therapy by clinical assessment of occurrence of major adverse cardiac events.

  up to 2 years

• 1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients

  comparison in intermediate high risk acute pulmonary embolism patients between conventional medical therapy and catheter-directed therapy as regarding safety and efficacy of the therapy by echocardiographic assessment of right ventricular function by TAPSE (mm) , RV/LV diameter ratio ,TR peak gradient (mmHg)

  up to 2 years

• 1.comparison between conventional medical therapy and catheter-directed therapy in intermediate high risk acute pulmonary embolism patients

  comparison in intermediate high risk acute pulmonary embolism patients between conventional medical therapy and catheter-directed therapy as regarding safety and efficacy of the therapy by CT pulmonary angiography to asses embolus size and Pulmonary artery obstruction index

  up to 2 years

Secondary Outcomes (1)

• predictors of progression from intermediate to high-risk acute pulmonary embolism patients

  up to 2 years

Other Outcomes (1)

• Implementation of pulmonary embolism response team at Assiut university hospitals

  up to 2 years

Study Arms (2)

catheter directed therapy group in intermediate risk pulmonary embolism patients

ACTIVE COMPARATOR

in this arm, intermediated risk pulmonary embolism patients is treated by intervention in the form of: * A. Mechanical embolectomy: by hydromechanical defragmentation by pigta * B. Suction embolectomy: using The Penumbra Indigo aspiration system * C. Catheter directed thrombolysis:

Procedure: Mechanical embolectomy: by hydromechanical defragmentation by pigtail; Device: Suction embolectomy by the Penumbra Indigo aspiration system

medical therapy group in intermediate risk pulmonary embolism patients

ACTIVE COMPARATOR

in this arm, intermediated risk pulmonary embolism patients is treated by routine anticoagulation only.

Procedure: Mechanical embolectomy: by hydromechanical defragmentation by pigtail; Device: Suction embolectomy by the Penumbra Indigo aspiration system

Interventions

Mechanical embolectomy: by hydromechanical defragmentation by pigtail PROCEDURE

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

catheter directed therapy group in intermediate risk pulmonary embolism patients; medical therapy group in intermediate risk pulmonary embolism patients

Suction embolectomy by the Penumbra Indigo aspiration system DEVICE

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

catheter directed therapy group in intermediate risk pulmonary embolism patients; medical therapy group in intermediate risk pulmonary embolism patients

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute pulmonary embolism patients (confirmed by CT pulmonary angiography \[CTPA\])
• symptoms started within 15 days of enrollment
• intermediate-high risk pulmonary embolism patients , i.e., who have all of the following risk indicators combined :(2) i.Pulmonary Embolism Severity Index (PESI) class III-V or sPESI ≥1, ii.AND RV dysfunction on TTE or CTPA, iii.AND elevated cardiac troponin levels
• with none of the following high-risk presentations: cardiac arrest, systolic blood pressure \<90 mmHg, or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status, or end-organ hypoperfusion.

You may not qualify if:

• high risk patients who are hemodynamically unstable (cardiogenic shock, SBP \<90 mmHg, or use of intotropic support).
• low risk patients with no RV dysfunction.
• Patients with history of CTEPH (or previous acute PE)
• Patients known to have other pulmonary hypertension, apart from group IV (CTEPH).
• Patients with sever kidney injury (eGFR \<30 mg/dl/1.7m2).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available.

  PMID: 25173341 BACKGROUND

• Giri J, Sista AK, Weinberg I, Kearon C, Kumbhani DJ, Desai ND, Piazza G, Gladwin MT, Chatterjee S, Kobayashi T, Kabrhel C, Barnes GD. Interventional Therapies for Acute Pulmonary Embolism: Current Status and Principles for the Development of Novel Evidence: A Scientific Statement From the American Heart Association. Circulation. 2019 Nov 12;140(20):e774-e801. doi: 10.1161/CIR.0000000000000707. Epub 2019 Oct 4.

  PMID: 31585051 BACKGROUND

• Hassan AKM, Ahmed H, Ahmed Y, Elfadl AA, Omar A. Efficacy and safety of hydro-mechanical defragmentation in intermediate- and high-risk pulmonary embolism. Egypt Heart J. 2021 Sep 25;73(1):84. doi: 10.1186/s43044-021-00204-2.

  PMID: 34564780 BACKGROUND

• Kroupa J, Buk M, Weichet J, Malikova H, Bartova L, Linkova H, Ionita O, Kozel M, Motovska Z, Kocka V. A pilot randomised trial of catheter-directed thrombolysis or standard anticoagulation for patients with intermediate-high risk acute pulmonary embolism. EuroIntervention. 2022 Oct 7;18(8):e639-e646. doi: 10.4244/EIJ-D-21-01080.

  PMID: 35620984 BACKGROUND

Study Officials

• Shrouk K Ali, MSc

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shrouk K Ali, MSc

CONTACT

+0201225134030; shrouk31@aun.edu.eg

Ayman Kh Hassan, MD

CONTACT

+0201094438055; Aymankhairy11@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled, open-label, parallel-assignment, prospective study

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: November 10, 2022
• Study Start: December 30, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share