Phase
Condition
Venous Thrombosis
Claudication
Vascular Diseases
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Subject has previously completed or withdrawn from this study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 StatesSite Not Available
Hoag Hospital
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
Yale New Haven Hospital
New Haven, Connecticut 06510
United StatesActive - Recruiting
Yale University
New Haven, Connecticut 06510
United StatesSite Not Available
Yale University
New Haven 4839366, Connecticut 4831725 06510
United StatesSite Not Available
Baptist Health South Florida
Miami, Florida 33176
United StatesSite Not Available
Baptist Health South Florida
Miami 4164138, Florida 4155751 33176
United StatesSite Not Available
IU Health Methodist Hospital
Indianapolis, Indiana 46204
United StatesSite Not Available
IU Health Methodist Hospital
Indianapolis 4259418, Indiana 4921868 46204
United StatesSite Not Available
MedStar Union Memorial Hospital
Baltimore, Maryland 21218
United StatesSite Not Available
MedStar Union Memorial Hospital
Baltimore 4347778, Maryland 4361885 21218
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
University Medical Center Las Vegas
Las Vegas, Nevada 89102
United StatesSite Not Available
University Medical Center Las Vegas
Las Vegas 5506956, Nevada 5509151 89102
United StatesSite Not Available
University Medical Center Southern Nevada
Las Vegas 5506956, Nevada 5509151 89102
United StatesSite Not Available
Englewood Hospital
Englewood, New Jersey 07631
United StatesSite Not Available
Englewood Hospital
Englewood 5097672, New Jersey 5101760 07631
United StatesSite Not Available
NYU Langone Medical Center
New York, New York 10016
United StatesSite Not Available
NYU Langone Medical Center
New York 5128581, New York 5128638 10016
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15212
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37203
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
University of Texas Medical Branch
Galveston, Texas 77555
United StatesSite Not Available
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
University of Texas Medical Branch
Galveston 4692883, Texas 4736286 77555
United StatesSite Not Available
University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
West Virginia University Hospital
Morgantown, West Virginia 26506
United StatesSite Not Available
West Virginia University Hospital
Morgantown 4815352, West Virginia 4826850 26506
United StatesSite Not Available

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