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Purpose

PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and 2. Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio > 1 on CT angiography

Exclusion Criteria

  1. Age < 18 years 2. Systolic blood pressure < 90 mmHg for >15 consecutive minutes or > 40 mmHg drop from baseline, or vasopressor requirement for blood pressure support (i.e., massive PE), occurring within 1 hour prior to eligibility assessment. 3. Symptom duration > 14 days for the current PE episode 4. Irreversible INR > 3 5. Irreversible Thrombocytopenia (Platelets < 50,000/microliter) 6. Creatinine > 2.0 mg/dl 7. Hemoglobin < 7.0 g/dl 8. Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential)) 9. Allergy or hypersensitivity to Recombinant Tissue Plasminogen Activator (rt-PA), or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used 10. Life expectancy < 1 year 11. Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound) 12. Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT) 13. Unable or unwilling to provide informed consent 14. Major contraindication or unsuitability for all CDT methods available at the Clinical Center

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Catheter-Directed Therapy (CDT) plus Anticoagulation 		Participants will receive CDT consisting of mechanical thrombectomy (MT) or intrathrombus catheter-directed thrombolysis (CDL) using FDA-cleared devices for pulmonary embolism (PE). The exact technique and devices used will be at the discretion of the endovascular physician, within parameters defined by the PE-TRACT Manual of Operations (MOP) and accepted standard care. Before and after CDT, patients will receive standard PE therapy as in the no-CDT Arm.
  • Drug: Anticoagulant Therapy
    All subjects will receive anticoagulation for a minimum of 3 months.
  • Device: Catheter-Directed Therapy
    The endovascular physician can choose to use either mechanical thrombectomy (MT) using a device cleared by the FDA to treat PE or catheter-directed thrombolysis (CDL) using an infusion catheter cleared by the FDA to administer thrombolytic drugs for the treatment of PE
Active Comparator
No Catheter-Directed Therapy (No-CDT) 		Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.
  • Drug: Anticoagulant Therapy
    All subjects will receive anticoagulation for a minimum of 3 months.

Recruiting Locations

The University of Alabama At Birmingham
Birmingham 4049979, Alabama 4829764 35233
Contact:
Samuel McElwee, MD
205-975-7123
skmcelwee@uabmc.edu

Stanford Medicine
Palo Alto 5380748, California 5332921 94304
Contact:
Andrew Kesselman, MD
650-723-6855
ajk266@stanford.edu

UC Davis Health
Sacramento 5389489, California 5332921 95817
Contact:
Roger Goldman
916-734-8462
regoldman@ucdavis.edu

Scripps Memorial Hospital, La Jolla
San Diego 5391811, California 5332921 92121
Contact:
Daniel S. Jones, MD
215-908-5726
Jones.Daniel@scrippshealth.org

The Lundquist Institute
Torrance 5403022, California 5332921 90502
Contact:
Janine Vintch, MD
310-222-8200
jvintch@dhs.lacounty.gov

Christiana Care
Newark 4143861, Delaware 4142224 19718
Contact:
George Kimbiris, MD
302-733-5625
gkimbiris@christianacare.org

MedStar Health Research Institute
Washington D.C. 4140963, District of Columbia 4138106 20010
Contact:
Saher Sabri, MD
202-877-3657
saher.s.sabri@medstar.net

Baptist Health Miami Cardiac & Vascular Institute
Miami 4164138, Florida 4155751 33176
Contact:
Ripal Gandhi, MD
786-596-5990
gandhi@baptisthealth.net

University of South Florida/ Tampa General Hospital
Tampa 4174757, Florida 4155751 33606
Contact:
Glenn Hoots, MD
813-844-4570
hoots@usf.edu

Emory University School of Medicine
Atlanta 4180439, Georgia 4197000 30308
Contact:
Wissam Jabar, MD
404-686-7568
wissam.jaber@emory.edu

University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637
Contact:
Jonathan D. Paul, MD
773-834-1497
jpaul@medicine.bsd.uchicago.edu

Advocate Good Samaritan Hospital
Downers Grove 4890119, Illinois 4896861 60515
Contact:
Mahesh Raju, MD
630-719-4799
Mahesh.raju@aah.org

Loyola University Chicago
Maywood 4901514, Illinois 4896861 60153
Contact:
Amir Darki, MD
708-216-4466
adarki@lumc.edu

Southern Illinois University School of Medicine
Springfield 4250542, Illinois 4896861 62781
Contact:
Abdul Moiz Hafiz
217-545-8000
ahafiz96@siumed.edu

University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Contact:
Kevin Doerschug
319-356-1445
kevin-doerschug@uiowa.edu

MaineHealth
Portland 4975802, Maine 4971068 04102
Contact:
Paul Kim, MD
207-956-6650
kimp9@spectrummg.com

Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
Contact:
Ashvin Pande, MD
617-638-8703
Ashvin.pande@bmc.org

Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
Contact:
Brett Carroll, MD
617-667-8800
bcarrol2@bidmc.harvard.edu

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
Contact:
Minhajuddin Khaja, MD, MBA
734-936-4478
mkhaja@med.umich.edu

Trinity Health - Ann Arbor Hospital
Ypsilanti 5015688, Michigan 5001836 48197
Contact:
Hriday Shah, MD
734-712-8350
hriday.shah@aiarad.com

Washington University in St. Louis
St Louis 4407066, Missouri 4398678 63110
Contact:
Pavan Kavali, MD
314-362-2900
pavan.kavali@wustl.edu

Rutgers New Jersey Medical School
Newark 5101798, New Jersey 5101760 07103
Contact:
Abhishek Kumar, M.D.
973-972-5188
kumarab@njms.rutgers.edu

University of New Mexico Health Sciences Center
Albuquerque 5454711, New Mexico 5481136 87131
Contact:
Carolina Ponce Orellana, MD
505-272-6020
CPonceOr@salud.unm.edu

NYU Langone Health - Tisch Hospital
New York 5128581, New York 5128638 10016
Contact:
Bedros Taslakian, MD, EBIR, FCIRSE
332-237-9866
bedros.taslakian@nyulangone.org

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
Contact:
Hooman Poor, MD
212-241-5656
hooman.poor@mountsinai.org

Weill Cornell Medicine
New York 5128581, New York 5128638 10065
Contact:
Christopher M. Harnain, MD, MBA, RPVI
212.746.4635
cmh9017@med.cornell.edu

Promedica
Toledo 5174035, Ohio 5165418 43606
Contact:
Zakaria Assi, MD
419-291-4438
zassi@buckeye-express.com

Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239
Contact:
Khashayar Farsad, MD, PhD
503-494-7226
farsad@ohsu.edu

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Steven Pugliese, MD
215-614-1527
Steven.Pugliese@pennmedicine.upenn.edu

Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Carin Gonsalves, MD
215-955-6609
Carin.Gonsalves@jefferson.edu

University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15232
Contact:
Rabih A. Chaer, MD
412-802-3025
chaerra@upmc.edu

Main Line Healh
Wynnewood 5220230, Pennsylvania 6254927 19096
Contact:
Lee Greenspon, MD
610-642-3796
GreensponL@MLHS.ORG

Lifespan
Providence 5224151, Rhode Island 5224323 02903
Contact:
DaeHee Kim, MD
401-444-5184
daehee_kim@brown.edu

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
Contact:
Kevin W. Dickey
843-792-5069
dickeyke@musc.edu

The University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 77030
Contact:
Bela Patel, MD
713-500-6831
Bela.patel@uth.tmc.edu

Intermountain Health
Murray 5778755, Utah 5549030 84107
Contact:
Mark Dodson, MD
801-507-4603
Mark.Dodson@imail.org

University of Utah Health
Salt Lake City 5780993, Utah 5549030 84108
Contact:
Nathan Hatton, MD
801-581-5811
nathan.hatton@hsc.utah.edu

Sentara Health Research Center
Norfolk 4776222, Virginia 6254928 23507
Contact:
David Dexter, MD
757-388-5480
djdexte1@sentara.com

Carilion Clinic
Roanoke 4782167, Virginia 6254928 24014
Contact:
Joseph A. Hughes, M.D
540-981-7083
jahughes1@carilionclinic.org

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Matthew J. Scheidt, MD
414-805-3125
mscheidt@mcw.edu

More Details

NCT ID
NCT05591118
Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Sunil Rao
212-263-0456
Sunil.rao@nyulangone.org

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