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Pulmonary Embolism and Thrombosis

Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism

Sponsored by Boston Scientific Corporation

About this trial

Last updated 4 years ago

Study ID

EKOS-12

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 5 years ago

What is this trial about?

The objective is to determine the optimum dose of thrombolytic and duration of the ultrasound procedure (together defined as the APT Procedure) as a treatment for acute submassive pulmonary embolism (PE). Symptomatic submassive PE are participants with acute (less than or equal to [≤]14 days) PE with normal systemic arterial blood pressure (greater than [>] 90 mmHg) and evidence of RV dysfunction (right ventricular to left ventricular diameter ratio, that is; RV/LV ratio greater than or equal to [≥] 0.9). Participants with submassive PE will be randomized to one of four APT treatment groups: ultrasound of 2 and 6 hours (hrs) with r-tPA 2 milligrams (mg)/hr/catheter and ultrasound 4 and 6 hours with r-tPA, 1 mg/hr/catheter. On 08 June 2016, randomization into treatment group 4 (APT/6 hours-r-tPA/2 mg/hr/catheter) was closed following a reported intracranial hemorrhage (ICH) and death in a study participant in this arm.

What are the participation requirements?

Yes

Inclusion Criteria

1. Male or female greater than or equal to (≥) 18 years of age and less than or equal to (≤) 75 years of age.

2. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery).

3. PE symptom duration ≤14 days.

4. Submassive PE: RV/LV diameter ≥ 0.9 from CTA and hemodynamically stable. For Participants in UK Sites: Submassive PE: RV/LV diameter ≥ 0.9 from CTA, hemodynamically stable and an elevated biomarker.

5. Must be treated within 48 hours of diagnosis of PE by CTA.

6. Signed Informed consent obtained from subject or Legally Authorized Representative.

No

Exclusion Criteria

1. Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year.

2. Recent (within one month) or active bleeding from a major organ.

3. Major surgery within seven days of screening for study enrollment.

4. Clinician deems the subject high-risk for catastrophic bleeding.

5. History of heparin-induced thrombocytopenia (HIT).

6. Catheter-based pharmacomechanical treatment for PE within 3 days of study enrollment.

7. Systolic blood pressure (SBP) less than 90 mm Hg and/or use of vasopressors.

8. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR).

9. Evidence of irreversible neurological compromise.

10. Life expectancy < one year. For Participants in UK Sites: Life expectancy < one year or enrollment in hospice care.

11. Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study.

12. Out-of-Range Laboratory Values: Hematocrit < 30%, Platelets < 100 thousand/microliter (μL), International normalized ratio (INR) > 3.

13. Creatinine outside the normal range for the treating institution.

14. Participant is pregnant (positive pregnancy test; women of childbearing capacity must be tested) or breast feeding.

15. Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: participants with non-melanoma primary skin cancers are eligible to participate in the study.

16. Known allergy, hypersensitivity, or thrombocytopenia from heparin, r-tPA, or iodinated contrast except for mild-moderate contrast allergies for which steroid pre-medication can be used.

17. History of any hematologic disease potentially involving abnormal platelet number or function.

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