Phase
Condition
Thrombosis
Venous Thromboembolism
Thromboembolism
Treatment
Percutaneous mechanical thrombectomy (PMT)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years
Planned intervention for DVT presenting with one or more of the followingcharacteristics indicative of elevated risk for PE:
Bilateral iliofemoral DVT
Clot extending into or located in the IVC
In-stent thrombosis
Presence of thrombosed IVC filter
Other features that the investigator deems put the subject at elevated risk forthromboembolism
Willing and able to provide informed consent
Exclusion
Exclusion Criteria:
Current symptomatic PE
Known anatomic inability to place Protrieve device via jugular vein access site
Presence of clot extending to the IVC-Right Atrial junction or in the SVC
Subject is pregnant
Severe allergy to iodinated contrast agents that cannot be mitigated
INR > 1.7 if not currently on anticoagulation therapy, platelets < 50,000/μl whichcannot be corrected prior to enrollment, or Hemoglobin < 8.0 g/dL
Severe renal impairment in patients who are not yet on dialysis that in theInvestigator's discretion would pose risk to the patient with the use of marketedcontrast agents
Subject is participating in another study that may interfere with this study
Subject has any condition for which, in the opinion of the Investigator,participation would not be in the best interest of the subject
Subject has previously completed or withdrawn from this study
Limb-threatening circulatory compromise (e.g., phlegmasia)
Uncontrolled severe hypertension on repeated readings (systolic > 180mmHg ordiastolic > 105mmHg)
Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
Inability to provide therapeutic anticoagulation per Investigator discretion
Known hypercoagulable states that, in the opinion of the Investigator, cannot bemedically managed throughout the study period
Inability to be a candidate for intervention due to medical or technical reasonsbased on physician judgement
Study Design
Study Description
Connect with a study center
Hoag Hospital
Newport Beach, California 92663
United StatesActive - Recruiting
Yale New Haven Hospital
New Haven, Connecticut 06510
United StatesActive - Recruiting
Yale University
New Haven, Connecticut 06510
United StatesActive - Recruiting
Baptist Health South Florida
Miami, Florida 33176
United StatesActive - Recruiting
IU Health Methodist Hospital
Indianapolis, Indiana 46204
United StatesActive - Recruiting
MedStar Union Memorial Hospital
Baltimore, Maryland 21218
United StatesActive - Recruiting
Englewood Hospital
Englewood, New Jersey 07631
United StatesActive - Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
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