ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism (ULTIMA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EKOS Corporation
ClinicalTrials.gov Identifier:
NCT01166997
First received: July 15, 2010
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

The ULTIMA study is intended to prove that in patients with pulmonary embolism and a right ventricular end diastolic diameter to left ventricular end diastolic diameter ratio ≥1 (RV/LV ratio) will benefit from treatment with ultrasound accelerated thrombolysis (rt-PA) as compared to unfractionated heparin anticoagulation. Specifically, at 24 hours the RV/LV ratio will be significantly reduced in the treatment arm compared to the control arm.


Condition Intervention Phase
Submassive Pulmonary Embolism
Device: EkoSonic Endovascular System
Drug: Unfractionated heparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Study Comparing EKOS EkoSonic Ultrasound Accelerated Thrombolysis to Anticoagulation in the Treatment of Sub-massive Pulmonary Embolism

Resource links provided by NLM:


Further study details as provided by EKOS Corporation:

Primary Outcome Measures:
  • Reduction of RV/LV ratio [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    RV/LV ratio will be measured by echocardiography at baseline. RV/LV ratio will be measured again by echocardiography at 24 hours.


Enrollment: 59
Study Start Date: July 2010
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound accelerated thrombolysis
Patients in this arm will receive anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System will be used to deliver a low dose <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
Device: EkoSonic Endovascular System
The EkoSonic Endovascular System will be used to deliver < 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus.
Active Comparator: Intravenous unfractionated heparin
Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment.
Drug: Unfractionated heparin
Intravenous unfractionated heparin used for anticoagulation treatment

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute PE symptoms < 14 days.
  • Filling defect by contrast-enhanced chest CT in at least one main or proximal lower lobe pulmonary artery
  • Right ventricular dysfunction confirmed by echocardiography where the RV/LV end diastolic diameter ratio is ≥ 1.0.

Exclusion Criteria:

  • Age less than 18 years or greater than 80 years
  • Index PE symptom duration > 14 days
  • Insufficient echocardiographic image quality in the apical or subcostal four-chamber view that prohibits the measurement of the right and left ventricular end-diastolic dimensions
  • Known significant bleeding risk
  • Administration of thrombolytic agents, e.g., tissue plasminogen activator, streptokinase, or urokinase, within the previous 4 days
  • Active bleeding
  • Known bleeding diathesis
  • Known coagulation disorder, platelet count < 100 000/mm3, or previous use of vitamin K antagonists with INR > 2.5
  • History of any intracranial or intraspinal surgery or trauma or intracranial/intraspinal bleed
  • Intracranial neoplasm, arteriovenous malformation, or aneurysm
  • Recent (< 3 months) GI bleeding.
  • Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
  • Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
  • Estimated glomerular filtration rate (eGFR) < 50 ml/min as calculated by the Cockroft formula.
  • Hemodynamic collapse at presentation defined as: need for cardiopulmonary resuscitation; or systolic blood pressure < 90 mm Hg for at least 15 min, or drop of systolic blood pressure by at least 40 mm Hg for at least 15 min with signs of end organ hypoperfusion (cold extremities or low urinary output < 30 mL/h or mental confusion); or need for catecholamine administration to maintain adequate organ perfusion and a systolic blood pressure of > 90 mm Hg.
  • Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105 mmHg).
  • Pregnant, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested).
  • Participating in any other investigational drug or device study.
  • Life expectancy < 90 days.
  • Inability to comply with study assessments (e.g. due to geographic distance).
  • Previous enrollment in this study
  • Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.
  • Known right-to-left shunt, for example from large patent foramen ovale or atrial septal defect
  • Large (>10 mm) right atrial or right ventricular thrombus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166997

Locations
Germany
Klinikum Lippe-Detmold
Detmold, Germany, 32756
Klinikum Dortmund gGmbH
Dortmund, Germany, 44137
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Germany, 01307
Universitätsklinikum der Ernst-Moritz-Arndt-Universität,
Greifswald, Germany, 17475
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Klinikum der Ludwig-Maximilians-Universität (LMU)
München, Germany, 81377
Christliches Krankenhaus Quakenbrueck
Quakenbrueck, Germany, 49610
Helios Klinikum Siegburg
Siegburg, Germany, 53721
SRH Zentralklinikum Suhl
Suhl, Germany, 98527
Switzerland
Inselspital Bern, Kliniken fur Kardiologie and Angiologie
Bern, Switzerland, 3010
Sponsors and Collaborators
EKOS Corporation
Investigators
Principal Investigator: Nils Kucher, Prof Dr med Inselspital Bern, Kliniken für Angiologie und Kardiologie
  More Information

No publications provided

Responsible Party: EKOS Corporation
ClinicalTrials.gov Identifier: NCT01166997     History of Changes
Other Study ID Numbers: EKOS Protocol Number 08
Study First Received: July 15, 2010
Last Updated: June 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic

Keywords provided by EKOS Corporation:
Pulmonary embolism
Pulmonary thromboembolism
anticoagulation
thrombolysis
ultrasound accelerated thrombolysis

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 01, 2014