Cohort Study on Treatment Comes of Catheter-based Therapy in Patients With Acute Pulmonary Embolism in Hong Kong

NCT07029841 | Recruiting FDA Device

• 1 other identifier: 2022.121
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective cohort study (Hong Kong PECT Registry) compares treatment outcomes between different percutaneous catheter-based therapies in patients with acute pulmonary embolism (PE). PE is a critical condition with potential for rapid deterioration and mortality before treatment. While availability of catheter-based therapy contributed to the declining mortality rates of PE, selecting the appropriate intervention remains key. There are primarily two modes of therapies available: Catheter-directed thrombolysis and Aspiration thrombectomy (e.g., Penumbra, Flowtriever, AlphaVac) Given limited direct comparisons between these methods, the study will evaluate their efficacy, safety, and clinical outcomes of these treatment strategies in acute PE patients.

Conditions

Pulmonary Embolism Acute; Pulmonary Embolism Acute Massive; Pulmonary Embolism Subacute Massive

Keywords

PE, CDT, LBAT, UACDT

Outcome Measures

Primary Outcomes (1)

• Inpatient mortality rates

  death of a patient occurring during the index hospitalization of pulmonary embolism.

  baseline, through hospital stay, an average of 7 days

Secondary Outcomes (7)

• procedural related complications

  baseline, 72 hours post operation

• major bleeding (as defined by BARC)

  baseline, 72 hours post operation

• hemoglobin change within 72 hours of the procedure

  baseline, 72 hours post operation

• change in the right ventricle to left ventricle ratio

  baseline, 72 hours post operation

• mean pulmonary artery pressure

  baseline, 72 hours post operation

Other Outcomes (2)

• 90 days overall mortality rate

  baseline, 90 days

• PE recurrence by 90 days

  baseline, 90 days

Study Arms (2)

catheter-directed thrombolysis (CDT)

Patient treated by any mode of catheter-directed thrombolysis, including ultrasound assisted catheter directed thrombolysis (EKOS).

Device: catheter-based therapy

Aspiration thrombectomy (AT)

Patient treated by any mode of aspiration thrombectomy, including large-bore mechanical thrombectomy (LBMT) such as Penumbra, Flowtriever, or Alphavac.

Device: catheter-based therapy

Interventions

catheter-based therapy DEVICE

catheter-based therapy

Aspiration thrombectomy (AT); catheter-directed thrombolysis (CDT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This registry aims to evaluate the efficacy and safety of patients with acute PE treated with catheter-based therapy.

You may qualify if:

• Patients who is admitted with a diagnosis of acute pulmonary embolism
• Patient who receives any types of catheter-based therapy for acute pulmonary embolism.

You may not qualify if:

• nil. This is a all-comer registry.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• China Medical University, Taiwan: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Focal cortical dysplasia of Taylor

Central Study Contacts

GuangMing Tan

CONTACT

852 +55699658; gtan@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 19, 2025
• Study Start: June 1, 2022
• Primary Completion (Estimated): December 28, 2032
• Study Completion (Estimated): December 30, 2032
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

HK (1)