RecruitingPulmonary Embolism

The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism

Eligible age

All ages

Accepts

All genders

Locations

15 states

Healthy volunteers

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About this study

To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE).

Sponsor: Thrombolex, Inc.

You may qualify if…

✓ 1. Willing and able to provide informed consent;
✓ 2. PE symptom duration ≤ 15 days;
✓ 3. Filling defect in at least one major lobar pulmonary artery as determined by CTA;
✓ 4. Patient is diagnosed with intermediate risk PE;
✓ 5. RV/LV diameter ratio ≥ 0.9 by CTA, as determined by investigative site;
✓ 6. Willing and able to comply with all study procedures and 7-day and 30-day telephone follow-up visit.

You may not qualify if…

✕ 1. Previous history of stroke with residual hemiplegia;
✕ 2. Major surgery ≤ 10 days prior to inclusion in the study;
✕ 3. Platelet count \< 100,000/μL;
✕ 4. Pulmonary thrombectomy within the previous 4 days;
✕ 5. Uncontrolled hypertension defined as systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg at the time of the procedure;
✕ 6. Administration of thrombolytic agents within the previous 4 days;
✕ 7. Absolute contraindication to anticoagulation;
✕ 8. Clinician deems high-risk for catastrophic bleeding;