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Long Term Effects of Treating Submassive Pulmonary Embolism With Ultra-sound Accelerated Thrombolysis (SPEAR)

S

Spectrum Health Hospitals

Status

Completed

Conditions

Submassive Pulmonary Embolism

Treatments

Other: submassive PA treatment with Ekosonic endo device

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01899339
2013-069
Ekos (Other Identifier)

Details and patient eligibility

About

Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an improved right ventricular function 72 hours post treatment.

Enrollment

25 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio > 0.9

Exclusion criteria

  • age > 80
  • Recent thrombolytic therapy (with in 4 days)
  • Active bleeding or know bleeding diathesis
  • Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or PTT > 50
  • Thrombocytopenia (PLT cound < 100,000)
  • History of any intracranial or intraspinal surgery, trauma or bleed
  • Intracranial neoplasms, AVM, or aneurysm
  • Recent (< 1 month) GI bleed
  • Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy
  • Recent (< 7 days) major surgery, trauma, or obstetrical delivery
  • Renal insufficiency with eGFR < 45 ml/min
  • Known allergy, hypersensitivity, or thrombocytopenia from heparin or tPA
  • Hemodynamic instability defined as need for cardiopulmonay resuscitation, Systolic BP > 90 mm Hg for > 15 min or need for pressor agents to maintain BP > 90.
  • Severe Hypertension (sustained systolic > 180 mm Hg or diastolic > 90 mm Hg.
  • Pregnant patients
  • known right to left shunt
  • Large (>10 mm)intracardiac thrombus
  • Use of thrombolytics or glycoprotein IIb/IIIa antangonists within 3 days of inclusion.
  • Life expectancy < 30 days

Trial design

25 participants in 1 patient group

pulmonary embolism
Description:
patients with submassive pulmonary embolism
Treatment:
Other: submassive PA treatment with Ekosonic endo device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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