Study of treatment of a blood clot located in the pulmonary artery(ies), to find the optimum duration of ultrasound and dose of a clot dissolving drug.

Phase 1

• Conditions: Submassive pulmonary embolism; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-000502-11-GB
• Lead Sponsor: EKOS Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-17
• Last Update Posted: 24 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Male or female = 18 years of age and = 75 years of age
2.Computed tomography angiography (CTA) evidence of proximal pulmonary embolism (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 haemodynamically stable
5.Treatment must be started within 48 hours of diagnosis of PE by CTA
6.Signed Informed consent obtained from subject or Legally Authorized Representative

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

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) 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 thrombocytopaenia (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
11.Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to APT procedure
12.Out-of-Range haematological parameter laboratory values: Haematocrit < 30%, Platelets < 100 thousand/µL, INR > 3,
13.Creatinine outside the normal range for the treating institution
14.Subject 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: subjects with non-melanoma primary skin cancers are eligible to participate in the study
16.Known allergy, hypersensitivity, or thrombocytopaenia from heparin, r-tPA, or iodinated contrast except for mild-moderate contrast allergies for which steroid pre-medication can be used

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified