An International Pulmonary Embolism Registry Using EKOS

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Retrospective and Prospective International EkoSonic® Registry of the Treatment and Clinical OUTcomes of Patients With Pulmonary Embolism

ClinicalTrials.gov ID

NCT03426124

Acronym / sponsor ID

KNOCOUT PE / BTG-001653-01

Conditions

Pulmonary Embolism and Thrombosis

Keywords

venous thromboembolism

Study type

Observational

Recruitment status

Completed

Enrolment

1,480 participants (actual)

Lead sponsor

Boston Scientific CorporationIndustry (pharma, biotech, devices)

Collaborators

BTG International Inc.

Study start

1 Mar 2018 (actual)

Primary completion

30 Jun 2020 (actual)

Study completion

30 Sep 2020 (actual)

First posted

8 Feb 2018 (actual)

Results

Posted 22 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Other

Target follow-up

1 Year

Number of arms

2

Who may qualify

Ages

18 to 80 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Individuals with intermediate-high and high risk pulmonary embolism who are selected to receive treatment using the EKOS device and thrombolytic.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available)

   Time frame: Baseline to post-procedure (end of procedure through hospital discharge up to 14 days)

   Difference (percent change) in the measurement of the right ventricular to left ventricular diameters (RV/LV) ratio as measured on baseline echocardiogram to post-procedure echocardiogram (24-48 hours post initiation of therapy).

2. Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization.

   Time frame: Post-procedure hospitalization through hospital discharge up to 14 days

   Measured by number of subjects requiring interventions of adjunctive therapies received during post procedure hospitalization through hospital discharge up to 14 days.

3. Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response.

   Time frame: From date of enrollment up to or until the placement of the Ekos device, on average 48 hours.

   Measured by number of patients who underwent interventional therapies prior to the APT procedure and experienced a non or partial response.

4. Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure.

   Time frame: From time of APT procedure through 12 months post-procedure.

   Number of subjects experiencing a SAE related to EKOS device and/or procedure from time of procedure through the first 12 months post-APT procedure, measured by frequency and severity of events.

5. All-cause Mortality During First 12 Months Post-procedure.

   Time frame: Start of procedure through 12 months post-procedure.

   Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure.

6. Healthcare Utilization

   Time frame: Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure).

   Summary of healthcare utilization from date of enrollment through discharge.

7. Change in Quality of Life (QOL) as Measured by the Pulmonary Embolism Quality of Life (PEmb-QOL) at the 3 Month and 12 Month Post-hospitalization Follow-up Visits

   Time frame: Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up.

   Reported as percent change in the PEmb-QOL questionnaire score from baseline timepoint to 3 months and 12 months. The PEmb-QOL measures patient's quality of life following pulmonary embolism on a scale of 1 through 5, with lower scores indicating a better outcome.

8. Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits.

   Time frame: Reported results include change from baseline to 3 months and 12 months post-procedure for prospective patients.

   Reported as change in the VAS, Utility and Misery questionnaire scores from baseline timepoint and/or study visit to 3 months and 12 months. The VAS (Visual Analogue Scale) is a one question, unidimensional measure of pain intensity where a subject is asked to rate his pain on a scale of 100 through 1, with 100 indicating the best health imaginable through 1 indicating the worst health imaginable. Higher scores indicate a better outcome. The EQ-5D is a series of questions that measures Quality of Life on a scale of 0 through 5. 0 indicates no problems in daily activities and 5 indicates inability to perform daily activities. The total score is added up and compared to the total scale from 0 to 25, with 0 indicating no problems in daily activities and 25 indicating inability to perform daily activities. A lower score indicates a better outcome.

9. Number of Patients Needing an IVC Filter Placement

   Time frame: From date of procedure through 12 months

   Measured by number patients with an occurrence of needing an IVC filter placement.

10. Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity

    Time frame: From post-procedure through 12-months post-procedure

    Measured by number of patients experiencing adverse events related to major bleeding events from time of procedure through the first 12 months post-procedure by frequency and severity (mild, moderate, severe).

11. Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity.

    Time frame: From post-procedure through 12-months post-procedure

    Number of patients experiencing events related to VTE from time of procedure through the first 12 months post-procedure by frequency and severity.

12. Diagnosis of Pulmonary Hypertension Diagnosis

    Time frame: Analyzed 12 months post-procedure

    New onset pulmonary hypertension defined as mean pulmonary artery pressure greater than 25 mm Hg by echocardiogram that persists at least 3 months after PE.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 38264938Sterling KM, Goldhaber SZ, Sharp ASP, Kucher N, Jones N, Maholic R, Meneveau N, Zlotnick D, Sayfo S, Konstantinides SV, Piazza G. Prospective Multicenter International Registry of Ultrasound-Facilitated Catheter-Directed Thrombolysis in Intermediate-High and High-Risk Pulmonary Embolism (KNOCOUT PE). Circ Cardiovasc Interv. 2024 Mar;17(3):e013448. doi: 10.1161/CIRCINTERVENTIONS.123.013448. Epub 2024 Jan 24.
• Individual participant dataSharing planned: No

Related trials for Pulmonary Embolism and Thrombosis

• RecruitingObservational study

  Clinical Management and Outcomes After Lung Scintigraphy for Suspected Pulmonary Embolism in the Emergency Department

  Pulmonary Embolism (Diagnosis)

• Not yet recruiting

  CTEPH Differential Diagnosis Assisted by Enhanced Large Language Model Support

  Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)

• Active, not recruitingPhase 3

  Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

  Pulmonary Embolism

• Not yet recruiting

  Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study

  Atrial Fibrillation (AF), Pulmonary Embolism (PE)

• Not yet recruitingPhase 2

  Phase IIA Study of Belzutifan in EPAS1-, EGLN1-, or VHL-Mutant Erythrocytosis

  Erythrocytosis, Pulmonary Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

80 sites in 8 countries: see every site and its status.