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Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism (OPTALYSE PE)

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ClinicalTrials.gov Identifier: NCT02396758
Recruitment Status : Active, not recruiting
First Posted : March 24, 2015
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
EKOS Corporation

Brief Summary:
The objective of the study is to determine the optimum dose of thrombolytic and duration of the ultrasound procedure as a treatment for acute submassive pulmonary embolism.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism and Thrombosis Device: EkosSonic Endovascular System plus thrombolytic Not Applicable

Detailed Description:
Subjects with pulmonary embolism with a RV/LV >0.9 and hemodynamically stable who meet all eligibility criteria and sign informed consent will be randomized to one of 4 treatment groups (see below). 48 hours after the start of treatment, a repeat CTA will be obtained and a RV/LV obtained. Thereafter, subjects will be followed for 12 months and an echocardiogram obtained at each clinic visit. Subjects will be monitored for occurrence of repeat PE and other serious adverse events.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in the Treatment of Acute Submassive Pulmonary Embolism
Actual Study Start Date : June 12, 2015
Actual Primary Completion Date : November 30, 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 2 hours APT Procedure and 4/8 mg rtPA
2 hr treatment with EkoSonic Endovascular System and either 4 or 8 mg of rtPA
Device: EkosSonic Endovascular System plus thrombolytic
Other Names:
  • Acoustic Pulse Thrombolysis Procedure (APT Procedure)
  • EKOS

Active Comparator: 4 hours APT Procedure and 4/8 mg rtPA
4 hr treatment with EkoSonic Endovascular System and either 4 or 8 mg of rtPA
Device: EkosSonic Endovascular System plus thrombolytic
Other Names:
  • Acoustic Pulse Thrombolysis Procedure (APT Procedure)
  • EKOS

Active Comparator: 6 hours APT Procedure and 6/12 mg rtPA
6 hr treatment with EkoSonic Endovascular System and either 6 or 12 mg of rtPA
Device: EkosSonic Endovascular System plus thrombolytic
Other Names:
  • Acoustic Pulse Thrombolysis Procedure (APT Procedure)
  • EKOS

Active Comparator: 6 hours APT Procedure and 12/24 mg rtPA
6 hr treatment with EkoSonic Endovascular System and either 12 or 24 mg of rtPA
Device: EkosSonic Endovascular System plus thrombolytic
Other Names:
  • Acoustic Pulse Thrombolysis Procedure (APT Procedure)
  • EKOS

Active Comparator: tbd
x hr treatment with EkoSonic Endovascular System and either x or x mg of rtPA
Device: EkosSonic Endovascular System plus thrombolytic
Other Names:
  • Acoustic Pulse Thrombolysis Procedure (APT Procedure)
  • EKOS




Primary Outcome Measures :
  1. improvement in RV/LV [ Time Frame: 48 hrs ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥ 18 years of age and ≤ 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
  5. Must be treated within 48 hours of diagnosis of PE by CTA
  6. Signed Informed consent obtained from subject or Legally Authorized Representative -

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
  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/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 thrombocytopenia from heparin, r-tPA, or iodinated contrast except for mild-moderate contrast allergies for which steroid pre-medication can be used -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396758


Locations
United States, California
Cedars Sinai
Beverly Hills, California, United States, 90211
United States, Florida
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Florida Hospital Tampa
Tampa, Florida, United States, 33613
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
University Hospital
Augusta, Georgia, United States, 30901
United States, Indiana
St. Vincent Medical Group
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
East Jefferson General Hospital
Metairie, Louisiana, United States, 70006
United States, Michigan
Detroit Medical Center
Detroit, Michigan, United States, 48201
Spectrum Health
Grand Rapids, Michigan, United States, 49506
United States, New York
NY-Presbyterian / Weill Cornell Med Cntr
New York, New York, United States, 10065
United States, Ohio
Mount Carmel health system
Columbus, Ohio, United States, 43213
United States, Pennsylvania
UPMC Hamot
Erie, Pennsylvania, United States, 16507
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Houston Methodist Sugarland Hospital
Richmond, Texas, United States, 77469
Sponsors and Collaborators
EKOS Corporation
Investigators
Principal Investigator: Victor Tapson, MD Cedar Sinai, Los Angeles

Responsible Party: EKOS Corporation
ClinicalTrials.gov Identifier: NCT02396758     History of Changes
Other Study ID Numbers: EKOS-12
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Embolism and Thrombosis
Thrombosis
Embolism
Pulmonary Embolism
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action