Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis (ATTRACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Washington University School of Medicine
Sponsor:
Collaborators:
McMaster University
Ontario Clinical Oncology Group (OCOG)
BSN Medical Inc
Genentech, Inc.
Covidien
Boston Scientific Corporation
Mid America Heart Institute
Society of Interventional Radiology Foundation
Massachusetts General Hospital
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00790335
First received: October 15, 2008
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy alone.


Condition Intervention Phase
Deep Vein Thrombosis
Venous Thrombosis
Postphlebitic Syndrome
Venous Thromboembolism
Post Thrombotic Syndrome
Drug: Recombinant tissue plasminogen activator (rt-PA)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Cumulative incidence of Post-Thrombotic Syndrome (Villalta Scale) [ Time Frame: within 24 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of post thrombotic syndrome, resolution of presenting DVT symptoms, the prevalence of valvular reflux and residual thrombus, the degree of clot lysis, and cost-effectiveness. [ Time Frame: within 24 months of randomization ] [ Designated as safety issue: No ]
  • Major bleeding, symptomatic pulmonary embolism, recurrent venous thromboembolism, and death [ Time Frame: within 10 days and 24 months after randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 692
Study Start Date: November 2009
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A-Intervention
PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm
Drug: Recombinant tissue plasminogen activator (rt-PA)
Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.
Other Names:
  • rt-PA
  • recombinant tissue plasminogen activator
  • Activase
  • Alteplase
No Intervention: B-Control
Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed

Detailed Description:

Activase, the study drug, is a fibrinolytic drug that is indicated for use in acute myocardial infarction, acute ischemic stroke, and acute massive pulmonary embolism in adults. Previous studies have established the ability of rt-PA to lyse venous thrombus in patients with deep vein thrombosis (DVT), and suggest that successful rt-PA mediated thrombolysis can prevent the post-thrombotic syndrome (PTS), a morbid, late complication of DVT that occurs in nearly 50% of patients.

rt-PA is delivered directly into venous thrombus using a catheter/device which is embedded within the thrombus by a physician under imaging guidance. This method of rt-PA delivery, pharmacomechanical catheter-directed intrathrombus thrombolysis (PCDT),is thought to be safer, more effective, and more efficient than previous methods. The question of whether PCDT using rt-PA improves long-term DVT patient outcomes with acceptable risk and cost has not yet been addressed.

The rationale for performing the ATTRACT Trial is based upon:

  • the major burden of PTS on DVT patients and the U.S. healthcare system
  • the association between rapid clot lysis and prevention of PTS
  • the proven ability of rt-PA to dissolve venous thrombus in proximal DVT
  • recent advances in CDT methods which may lower bleeding risk
  • the major clinical controversy on whether CDT should be routinely used for first-line DVT therapy
  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic proximal DVT involving the iliac, common femoral, and/or femoral vein.

Exclusion Criteria:

  • Age less than 16 years or greater than 75 years.
  • Symptom duration > 14 days for the DVT episode in the index leg (i.e., non-acute DVT).
  • In the index leg: established PTS, or previous symptomatic DVT within the last 2 years.
  • In the contralateral (non-index) leg: symptomatic acute DVT a) involving the iliac and/or common femoral vein; or b) for which thrombolysis is planned as part of the initial therapy.
  • Limb-threatening circulatory compromise.
  • PE with hemodynamic compromise (i.e., hypotension).
  • Inability to tolerate PCDT procedure due to severe dyspnea or acute systemic illness.
  • Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
  • Hemoglobin < 9.0 mg/dl, INR > 1.6 before warfarin was started, or platelets < 100,000/ml.
  • Moderate renal impairment in diabetic patients (estimated GFR < 60 ml/min) or severe renal impairment in non-diabetic patients (estimated GFR < 30 ml/min).
  • Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
  • Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
  • History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
  • Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: patients with non-melanoma primary skin cancers are eligible to participate in the study.
  • Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105 mmHg).
  • Pregnant (positive pregnancy test, women of childbearing potential must be tested).
  • Recently (< 1 mo) had thrombolysis or is participating in another investigational drug study.
  • Use of a thienopyridine antiplatelet drug (except clopidogrel) in the last 5 days.
  • Life expectancy < 2 years or chronic non-ambulatory status.
  • Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790335

Contacts
Contact: Patty M Nieters, RN, BSN 314 362 3371 nietersp@mir.wustl.edu

  Hide Study Locations
Locations
United States, Arizona
Arrowhead Hospital/Phoenix Heart, PLLC Recruiting
Glendale, Arizona, United States, 85306
Contact: Bijal Dave    602-298-7777 ext. 123    phxheartresearch@aol.com   
Principal Investigator: Rahul Malhotra, MD,FACC, FSCAI         
Sub-Investigator: Rajul I Patel, MD, FACC         
Sub-Investigator: Fred H Cucher, MD, FACC         
Sub-Investigator: Ronald K. Sterrenberg, MD         
Sub-Investigator: G. Reshmaal D Gomes Cumaranatunge, MD, MRCP         
United States, California
St. Joseph Hospital Recruiting
Orange, California, United States, 92868
Contact: Sandy Chung, RN    714-744-8795    sandy.chung@stjoe.org   
Principal Investigator: Mahmood Razavi, M.D.         
Sub-Investigator: Kurt Openshaw, M.D.         
Sub-Investigator: D. Preston Flanigan, M.D.         
Sub-Investigator: Michael Chan, MD         
Sub-Investigator: Christopher Loh, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Fizaa Ahmed    650-725-6409    fiza@stanford.edu   
Principal Investigator: Lawrence "Rusty" Hofmann, M.D.         
Sub-Investigator: Daniel Sze, M.D.         
Sub-Investigator: William T Kuo, M.D.         
Sub-Investigator: John D. Louie, M.D.         
Sub-Investigator: Gloria Hwang, M.D.         
Sub-Investigator: David Hovsepian, M.D.         
Sub-Investigator: Nishita Kothary, M.D.         
Sub-Investigator: Caroline Berube, M.D.         
Sub-Investigator: Donald Schreiber, M.D.         
Sub-Investigator: Brooke Jeffrey, M.D.         
United States, Connecticut
Danbury Hospital Recruiting
Danbury, Connecticut, United States, 06810
Contact: Judith Nagy, CCRC    203-739-7852    judith.nagy@danhosp.org   
Contact: Suzanne A. House, M.S., PhD    203-749-5610    suzanne.house@danhosp.org   
Principal Investigator: Alan M. Dietzek, M.D.         
Sub-Investigator: Ira Galin, M.D.         
Sub-Investigator: Patrick Broderick, M.D.         
Sub-Investigator: Andrew Keller, M.D.         
Sub-Investigator: Dahlia Plummer, M.D.         
Sub-Investigator: Richard Hsu, MD         
Eastern Connecticut Hematology and Oncology Associates Recruiting
Norwich, Connecticut, United States, 06360
Contact: Nancy Wilcox, RN    860-886-8362 ext 296    nwilcox@echoct.org   
Contact: Susan Johnson, Pharm. D.    860-886-8362    drsusanjohnson@cox.net   
Principal Investigator: Dennis E. Slater, MD         
Sub-Investigator: Mandeep S. Dhami, MD         
Sub-Investigator: Phillip Kohanski, MD         
Sub-Investigator: Anca M. Bulgaru, MD         
Sub-Investigator: Renuka Dulala, MD         
Sub-Investigator: Herb Lustberg, MD         
Sub-Investigator: Jan Akus, MD         
Sub-Investigator: James Burch, MD         
Sub-Investigator: Dinesh Kapur, MD         
Sub-Investigator: Jie Yang, MD, PhD         
Sub-Investigator: Robert Sidman, MD         
United States, Delaware
Christiana Care Health Systems Recruiting
Newark, Delaware, United States, 19718
Contact: Andrea Squire, RN, MSN    302-733-2658    asquire@christianacare.org   
Contact: Angela DiSabatino, RN, MS    302 733 5643    ADiSabatino@Christianacare.org   
Principal Investigator: Mark Garcia, MD         
Sub-Investigator: George Kimbiris, MD         
Sub-Investigator: Daniel Leung, MD         
Sub-Investigator: Michael Dignazio, MD         
Sub-Investigator: Michael Stillabower, MD         
Sub-Investigator: Paul Sierzenski, MD         
Sub-Investigator: Leila Getto, MD         
Sub-Investigator: Tuhina Raman, MD         
United States, District of Columbia
Georgetown University Hospital Completed
Washington, District of Columbia, United States, 20007
United States, Florida
Mease Countryside Hospital Completed
Clearwater, Florida, United States, 33761
Baptist Cardiac & Vascular Institute Completed
Miami, Florida, United States, 33176
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Kimberly Mink, RN    407-303-5600 ext 110-2249    Kimberly.mink@flhosp.org   
Principal Investigator: Mark Ranson, MD         
Sub-Investigator: Manuel R Perez, MD         
Sub-Investigator: Robert P Winter, MD         
Sub-Investigator: Alan R Wladis, MD         
Sub-Investigator: Tarek Mekhail, MD         
Sub-Investigator: David Varnagy, M.D.         
Florida Hospital-Tampa Division-Pepin Heart Institute and Dr. Kiran C. Patel Research Institute Recruiting
Tampa, Florida, United States, 33613
Contact: Juliet Bala    813-615-7527    jbala@mail.uch.org   
Contact: Elizabeth Szymanski, RN, BSN    813-615-7200 ext 56504    eszymanski@mail.uch.org   
Principal Investigator: Vasco M. Marques, MD         
Sub-Investigator: Yasir Al-Hassani, MD         
Sub-Investigator: Asad Sawar, M.D.         
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Margaret Pocius, R.N, B.S.N.    312-996-1574    mpocius@uic.edu   
Contact: Lisa Landers, NP    312-99-1574    landersl@UIC.EDU   
Principal Investigator: Martha Gracia Knuttinen, MD         
Sub-Investigator: James Bui, M.D.         
Sub-Investigator: Ron Gaba, M.D.         
Sub-Investigator: Valerie Dobiesz, M.D.         
Sub-Investigator: Sangeetha Nimmagadda, M.D.         
Sub-Investigator: Sudhir Hansalia, M.D.         
Sub-Investigator: Ejaz Shamim, M.D.         
Sub-Investigator: David Peace, M.D.         
Sub-Investigator: Charles Ray, MD         
Adventist Midwest Health Recruiting
Hinsdale, Illinois, United States
Contact: Kathleen Mansell, RN, MSN, CCRC    (708) 245-8161    Kathleen.Mansell@AHSS.ORG   
Contact: Kelly Barger, RN       kelly.barger@ahss.org   
Principal Investigator: Michael Sichlau, MD         
Sub-Investigator: Luke Sewall, MD         
Sub-Investigator: Francis Facchini, MD         
Sub-Investigator: Steven Smith, MD         
Sub-Investigator: Athanasios Vlahos, MD         
Sub-Investigator: Quinn Thalheimer, PA-C         
Sub-Investigator: Nisha Singh, PA-C         
Sub-Investigator: Rekha Harting, MD         
Sub-Investigator: John Gocke, MD         
Sub-Investigator: Scott Guth, MD         
Southern Illinois University Active, not recruiting
Springfield, Illinois, United States, 62702
Central DuPage Hospital Recruiting
Winfield, Illinois, United States, 60190
Contact: Sarah Madia    630-933-5281    Sarah.Madia@cadencehealth.org   
Principal Investigator: Joseph R Schneider, MD         
Sub-Investigator: Nilesh Patel, MD         
Sub-Investigator: Stanley Kim, MD         
Sub-Investigator: Farrah Hashemi, MD         
Sub-Investigator: Joseph Boyle, MD         
United States, Indiana
CorVasc Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Patrice Powell    317-583-6313    ppowell@thecaregroup.com   
Principal Investigator: Kannan Natarajan, MD         
Sub-Investigator: Jeffrey Cooke, MD         
Sub-Investigator: Vincent Flanders, MD         
Sub-Investigator: Brandon Martinez, MD         
Sub-Investigator: Marc Underhill, MD         
United States, Iowa
University of Iowa Carver's College of Medicine Recruiting
Iowa City, Iowa, United States, 52242
Contact: Emily Avgenackis    319-384-9131    emily-avgenackis@uiowa.edu   
Contact: Connie Shelsky, RN, MSN    319-384-4126    constance-shelsky@uiowa.edu   
Principal Investigator: Mel Sharafuddin, MD         
Sub-Investigator: Rachael Nicholson, MD         
Sub-Investigator: Steven Lentz, MD         
Sub-Investigator: Andrew Nugent, MD         
Sub-Investigator: William Sharp, MD         
Sub-Investigator: Timothy Kresowik, MD         
Sub-Investigator: Shiliang Sun, MD         
United States, Kentucky
St. Elizabeth Healthcare of Northern Kentucky Recruiting
Florence, Kentucky, United States, 41042
Contact: Michelle Parker, RN, BSN    859-301-4725    Michelle.Parker@stelizabeth.com   
Contact: Brian Burkhardt, APRN, MSN    859-212-4888    Brian.Burkhardt@stelizabeth.com   
Principal Investigator: Darren R Hurst, MD         
Sub-Investigator: Daniel Kim, MD         
Sub-Investigator: David Lubbers, MD         
Sub-Investigator: Brent Warren, MD         
Sub-Investigator: Jeremy Engel, MD         
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Debra Burris, RN    207-396-8077    morgad@mmc.org   
Contact: Rachel Tarmy, PA-C    207-662-4103    tarmyr9@spectrummg.com   
Principal Investigator: Paul Kim, MD         
Sub-Investigator: George Higgins, MD         
Sub-Investigator: Marc Jacquet, MD         
Sub-Investigator: Tom Dykes, MD         
Sub-Investigator: Joseph Gerding, MD         
Sub-Investigator: Christopher Baker, MD         
Sub-Investigator: Mark DeBiasio, PA-C         
Sub-Investigator: Derek Mittleider, MD         
United States, Maryland
University of Maryland Active, not recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital Active, not recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: LaDonna Austin    734-936-8275    ladonna@med.umich.edu   
Principal Investigator: David Williams, MD         
Sub-Investigator: Joseph Gemmete, MD         
Sub-Investigator: Vekataramu Krishnamurthy, MD         
Sub-Investigator: Wojciech Cwikiel, MD         
Sub-Investigator: Kyung Cho, MD         
Sub-Investigator: James J Shields, MD         
Sub-Investigator: Ranjith Vellody, MD         
Sub-Investigator: Paula Novelli, MD         
Sub-Investigator: Narasimham L Dasika, MD         
Sub-Investigator: Thomas W Wakefield, MD         
Sub-Investigator: John E Rectenwald, MD         
Sub-Investigator: Peter K Henke, MD         
Sub-Investigator: Jeffrey S Desmond, MD         
Sub-Investigator: James B Froehlich, MD         
Sub-Investigator: Jonathan Eliason, MD         
Ann Arbor Veteran's Administration Health System Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: LaDonna Austin    734-936-8275    ladonna@med.umich.edu   
Contact: Mary Burton       mjburt@med.umich.edu   
Principal Investigator: Venkataramu Krishnamurthy, MD         
Sub-Investigator: Peter K Henke, MD         
Sub-Investigator: John E Rectenwald, MD         
Sub-Investigator: Guillermo Escobar, MD         
Sub-Investigator: Jonathon Willalt, MD         
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Crystal Bradley, RN, BSN    313-916-1011    CBRADLE4@hfhs.org   
Contact: Andrei Rus       ARUS1@hfhs.org   
Principal Investigator: Judith Lin, MD         
Sub-Investigator: Joseph Miller, MD         
Sub-Investigator: Todd Getzen, MD         
Sub-Investigator: Scott Kaatz, DO,MScFACP         
Sub-Investigator: Loay S Kabbani, MD         
United States, Minnesota
University of Minnesota Active, not recruiting
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Connie L. Sathre    507-538-0540    sathre@mayo.edu   
Sub-Investigator: Haraldur Bjarnason, MD         
Sub-Investigator: Robert D McBane, MD         
Sub-Investigator: Aneel Ashrani, MD         
Principal Investigator: Sanjay Misra, MD         
Sub-Investigator: Waldemar Wysokinski, MD         
Sub-Investigator: Thanila Macedo, MD         
Sub-Investigator: Jeremy Friese, MD         
Sub-Investigator: Chad Fleming, MD         
Sub-Investigator: Andrew H. Stockland, MD         
Sub-Investigator: Michael A. McKusick, M.D.         
Sub-Investigator: David A Woodrum, MD, PhD         
Sub-Investigator: John A Heit, MD         
Sub-Investigator: Manju Kalra, MBBS         
United States, Missouri
St. Luke's Hospital of Kansas City Active, not recruiting
Kansas City, Missouri, United States, 64111
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Patty M Nieters, RN, BSN    314-362-3371    nietersp@mir.wustl.edu   
Contact: Mary Clare Derfler, RN, MSN    314-747-2372    derflerm@mir.wustl.edu   
Principal Investigator: Suresh Vedantham, MD         
Sub-Investigator: Nael Saad, MD         
Sub-Investigator: Lawrence Lewis, MD         
Sub-Investigator: Gregorio A Sicard, MD         
Sub-Investigator: Morey Blinder, MD         
Sub-Investigator: Mark Thoelke, MD         
Sub-Investigator: Robert Pallow, MD         
Sub-Investigator: Seth Klein, MD         
United States, Nebraska
Saint Elizabeth Regional Medical Center Recruiting
Lincoln, Nebraska, United States, 68510-2494
Contact: Paul Edwards    402-219-7677    pedwards@stez.org   
Contact: Karri Donahue    402-219-7936    karridonahue@catholichealth.net   
Principal Investigator: Eric Vander Woude, MD         
Sub-Investigator: Rahul Razdan, MD         
Sub-Investigator: Mark R Hutchins, M.D.         
Sub-Investigator: Daniel F. Moravec, M.D.         
Sub-Investigator: Joni A. Tilford, M.D.         
Sub-Investigator: Madhu V. Midathada, M.D.         
Sub-Investigator: Terry L Rounsborg, M.D.         
United States, New Jersey
Holy Name Hospital Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Yitzchak Y. David, MPH    201-530-7968    y-david@holyname.org   
Principal Investigator: John Rundback, MD         
Sub-Investigator: Richard Schwarb, MD         
Sub-Investigator: Randolph Cole, MD         
Sub-Investigator: Joseph Manno, MD         
Sub-Investigator: Kevin Herman, MD         
Sub-Investigator: David Singh, MD         
United States, New Mexico
University of New Mexico Active, not recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
Cornell Weill Medical Center Recruiting
New York, New York, United States, 10021
Contact: Jamie Stern    212-746-9748    Jas2071@med.cornell.edu   
Contact: Angela Hoang       anh2016@med.cornell.edu   
Principal Investigator: Akhilesh Sista, M.D.         
Sub-Investigator: David Madoff, MD         
Sub-Investigator: Maria DeSancho, MD         
Sub-Investigator: Raffaele Milizia, MD         
Sub-Investigator: Jing Gao, MD, RVT         
Sub-Investigator: Bradley Pua, MD         
Sub-Investigator: Ronald Winokur, MD         
Staten Island University Hospital Recruiting
Staten Island, New York, United States, 10305
Contact: Gabriella Taflin, RN    718-226-9143    gabriella.taflin@gmail.com   
Principal Investigator: Jonathan Schor, MD         
Sub-Investigator: Jonathan Deitch, MD         
Sub-Investigator: Kuldeep Singh, MD         
Sub-Investigator: Barry Hahn, MD         
Sub-Investigator: Shilpi Guptra, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7035
Contact: Cheryl Jeanneret    919-843-5302    ccjeanne@med.unc.edu   
Principal Investigator: Stephan Moll, MD         
Sub-Investigator: Raj Kasthuri, MD         
Sub-Investigator: Nigel Key, MB FRCCP         
Sub-Investigator: Joseph M Stavas, MD, FACR         
Sub-Investigator: Matthew A Mauro, MD, FACR, FAHA         
Sub-Investigator: Charles Burke, MD         
Sub-Investigator: Robert Dixon, MD         
Sub-Investigator: Blair A. Keagy, MD         
Sub-Investigator: Hyeon Yu, MD         
Wake Forest University Baptist Medical Center Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Robert Paris, RN    336-716-3296    rparis@wfubmc.edu   
Sub-Investigator: Matthew Edwards, MD         
Principal Investigator: Randolph Geary, MD         
Sub-Investigator: Pavel Levy, MD         
Sub-Investigator: Christopher Godshall, MD         
Forsyth Medical Center Completed
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Good Samaritan Hospital Recruiting
Cincinatti, Ohio, United States, 45220
Contact: Susan Reilly, RN, BSN    513-862-2877    susan_reilly2@trihealth.com   
Contact: Lori Reid, RN, BSN    513-862-2877    lori_reid@trihealth.com   
Principal Investigator: Patrick Muck, MD         
Sub-Investigator: Kurt Knochel, MD         
Sub-Investigator: Joann Lohr, MD         
Sub-Investigator: Jose Barreau, MD         
Sub-Investigator: Matthew Recht, MD         
Sub-Investigator: Brian Kuhn, M.D.         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jackie McCluskey, RN    216-444-4803    mcclusj@ccf.org   
Contact: Linda Kerchenski, RN    216 445 1174    kerchel@ccf.org   
Principal Investigator: Heather Gornik, MD         
Sub-Investigator: John R Bartholomew, MD, FACC         
Sub-Investigator: Daniel G Clair, MD, FACS         
Sub-Investigator: Soo Hyun Kim, MD. MPH         
Sub-Investigator: Douglas E Joseph, DO, RVT         
Sub-Investigator: Sean P Lyden, MD         
Sub-Investigator: Gordon McLennan, MD         
Sub-Investigator: Mehdi Shishehbor, MD         
Sub-Investigator: Frank Peacock, M.D.         
Sub-Investigator: Reza Amini, M.D.         
Sub-Investigator: Gregory Pierce, M.D.         
Sub-Investigator: Baljendra Kapoor, M.D.         
Sub-Investigator: Natalia Fendrikova-Mahlay, MD         
Sub-Investigator: Aaron Hamilton, MD         
Sub-Investigator: James Newman, MD         
Sub-Investigator: James Spain, MD         
Sub-Investigator: Amanjiit Gill, MD         
Sub-Investigator: Anthony Rizzo, MD         
Sub-Investigator: Woosup Park, M.D.         
Riverside Methodist Hospital Active, not recruiting
Columbus, Ohio, United States, 43214
Jobst Vascular Center Recruiting
Toledo, Ohio, United States, 43606
Contact: Regina Zoller, RN, BSN    419-291-2087    Regina.Zoller@ProMedica.org   
Contact: Angie Link, RN, BSN    419 291 3563    angie.link@promedica.org   
Sub-Investigator: John P Pigott, MD         
Sub-Investigator: Andrew J Seiwert, MD         
Sub-Investigator: Ralph C Whalen, MD         
Sub-Investigator: Todd E Russell, MD         
Sub-Investigator: Zakaria Assi, MD         
Sub-Investigator: Sahira Kazanjian, MD         
Sub-Investigator: Jonathan Yobbagy, MD         
Sub-Investigator: Brian Kaminski, MD         
Principal Investigator: Anthony J. Comerota, MD         
Sub-Investigator: Subash Thakur, MD         
Sub-Investigator: Garett Begeman, MD         
United States, Oregon
Oregon Health & Science University Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
St. Luke's Hospital and Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Eileen Taff, R.N., M.S.N.    484-526-2450    taffe@slhn.org   
Contact: Ghada Suleiman, RN    484-526-7825    suleimg@slhn.org   
Principal Investigator: Jamie L. Thomas, M.D.         
Sub-Investigator: Michael A. Ringold, M.D.         
Sub-Investigator: Prasant R. Patel, M.D.         
Sub-Investigator: James D. Balshi, M.D.         
Sub-Investigator: Ellen A. Redstone, M.D.         
Sub-Investigator: Justin P. Psaila, M.D.         
Sub-Investigator: Amy L. Lipscomb, M.D.         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States
Contact: Jenny Wong, RN    217-707-5340    wongjk@tuhs.temple.edu   
Contact: Kathleen Wilson    217-707-5340    Kathleen.Wilson@tuhs.temple.edu   
Principal Investigator: Riyaz Bashir, M.D.         
Sub-Investigator: A. Koneti Rao, M.D.         
Sub-Investigator: Manish Garg, M.D.         
Sub-Investigator: Pravin Patil, M.D.         
Sub-Investigator: Frank Schmieder, M.D.         
Sub-Investigator: Gary Cohen, M.D.         
Sub-Investigator: Valdmir Lakhter, M.D.         
Sub-Investigator: Chad Zack, M.D.         
Albert Einstein Medical Center Active, not recruiting
Philadelphia, Pennsylvania, United States, 19141
The Western Pennsylvania Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Rich Wonder, RN    412-578-4492    rwonder@wpahs.org   
Contact: Lori Stover, RN, BSN       lstover@wpahs.org   
Sub-Investigator: Gordon K. McLean, MD         
Sub-Investigator: Robert Kaplan, M.D.         
Sub-Investigator: Sanualah Khalid, M.D.         
Principal Investigator: Swapna Goday, MD         
University of Pittsburgh Medical Center Presbyterian Shadyside Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Judith A. Brimmeier, BSN, CCRC    412-235-1304    brimmeierj@upmc.edu   
Contact: Dana Lowers, RN    412-623-8452    lowersdr@upmc.edu   
Principal Investigator: Rabih Chaer, MD         
Sub-Investigator: Michel Makaroun, M.D.         
Sub-Investigator: Luke Marone, M.D.         
Sub-Investigator: Margaret Hseih, MD         
Sub-Investigator: Geetha Jeyabalan, M.D.         
Sub-Investigator: Kristan Feterik, M.D.         
Sub-Investigator: Jennifer Rogers, M.D.         
Sub-Investigator: Roy E. Smith, M.D.         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Sue Ann Livingston    412-359-8763    saliving@wpahs.org   
Contact: Rich Wonder, RN    412-578-44355    rwonder@wpahs.org   
Sub-Investigator: Robert Kaplan, MD         
Sub-Investigator: Gordon McLean, MD         
Sub-Investigator: Arvind Venkat, M.D.         
Principal Investigator: Swapna Goday, MD         
The Reading Hospital and Medical Center Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Catherine Geary, RN    484-628-8355    Catherine.Gery@readinghealth.org   
Contact: Crystal Nagle, MA    610-988-4308    naglec@readinghospital.org   
Principal Investigator: David Sacks, M.D.         
Sub-Investigator: Adam Sigal, M.D.         
Sub-Investigator: Mark Scott, DO         
Sub-Investigator: Robert Guay, MD         
Sub-Investigator: Nick Leasure, MD         
Sub-Investigator: Terrence Cescon, MD         
Sub-Investigator: Karekin Cunningham, MD         
Sub-Investigator: Thiruvenkatasamy Dhurairaj, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Gregory McEnteggart    401-444-1739    gmcenteggart@lifespan.org   
Contact: Muhammed Naeem    (401) 444-5796    mnaeem@Lifespan.org   
Principal Investigator: Timothy Murphy, MD         
Sub-Investigator: Sun Ho Ahn, MD         
Sub-Investigator: Richard Haas, MD         
Sub-Investigator: Bryan Jay, MD         
Sub-Investigator: Gregory Soares, MD         
Sub-Investigator: James Klinger, MD         
Sub-Investigator: Gregory Jay, MD         
Sub-Investigator: Robert Tubbs, MD         
Sub-Investigator: Gregory Dubel, MD         
Sub-Investigator: Michael Beland, MD         
Sub-Investigator: Ryan O'Hara, MD         
Sub-Investigator: Ethan Prince, MD         
Sub-Investigator: Joselyn Cerezo, MD         
Sub-Investigator: Chad Thompson, M.D.         
Sub-Investigator: Lawrence Keating, M.D.         
Sub-Investigator: Aaron Frodsham, M.D.         
United States, South Carolina
Medical University of South Carolina Active, not recruiting
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Kim Dutton    214-648-7815    Kim.Dutton@UTSouthwestern.edu   
Principal Investigator: Steven Hsu, M.D., M.B.A         
Sub-Investigator: Yu-Min Shen, MD         
Sub-Investigator: Matthew Anderson, MD         
Sub-Investigator: Anil Pillai, MD         
Sub-Investigator: Seth Toomay, MD         
Sub-Investigator: Clayton Trimmer, DO         
Sub-Investigator: Dharam Kumbhani, MD         
Sub-Investigator: Sanjeeva Kalva, MD         
Sub-Investigator: Mark Reddick, MD         
Sub-Investigator: Steven Reis, MD         
United States, Utah
Utah Valley Regional Medical Center Active, not recruiting
Provo, Utah, United States, 84604
University of Utah Active, not recruiting
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Katie Rae, RN    434-243-0315    KAW3J@hscmail.mcc.virginia.edu   
Contact: Douglas Spaulding, RN    434-243-0315    DCS7R@hscmail.mcc.virginia.edu   
Principal Investigator: John F Angle, MD         
Sub-Investigator: B. Gail Macik, MD         
Sub-Investigator: Saher S Sabri, MD         
Sub-Investigator: Alan H Matsumoto, MD         
Sub-Investigator: Auh-Whan Park, MD         
Sub-Investigator: George M Hoke, MD         
Sub-Investigator: Benjamin P Sneed, MD         
Sub-Investigator: John A. Kern, MD         
Sub-Investigator: Kelly M. Davidson, MD         
Sub-Investigator: James R. Stone, M.D.         
Sub-Investigator: Scott Syverud, M.D.         
Sub-Investigator: Aditya Sharma, M.D.         
Sub-Investigator: Luke Wilkins, MD         
Sub-Investigator: Ziv Haskal, MD         
United States, Washington
Sacred Heart Medical Center Active, not recruiting
Spokane, Washington, United States, 99204
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Susan L. Collins, MSN, RN, CCRC    304-293-7348    scollins@hsc.wvu.edu   
Principal Investigator: Brent T. Steadman, M.D., Ph.D., RPVI         
Sub-Investigator: Patricia Stoltzfus, MD         
Sub-Investigator: Mayada Issa, MD         
United States, Wisconsin
Gundersen Clinic, Ltd. Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Tracey Coleman       tscolema@gundersenhealth.ort   
Contact: Sara Meyers       srmeyers@gundersenhealth.org   
Principal Investigator: Ezana Azene, MD         
Sub-Investigator: Wayne Bottner, MD         
Sub-Investigator: William Bishop, MD         
Sub-Investigator: Dave Clayton, MD         
Sub-Investigator: Lincoln Gundersen, MD         
Sub-Investigator: Jody Riherd, MD         
Sub-Investigator: Irina Shakhnovich, MD         
Sub-Investigator: Kurt Ziegelbein, MD         
Medical College of Wisconsin/Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Elizabeth Weil    414-805-2077    eweil@mcw.edu   
Principal Investigator: Parag J Patel, MD         
Sub-Investigator: Robert A Hieb, MD         
Sub-Investigator: William S Rilling, MD         
Sub-Investigator: Sean M Tutton, MD         
Sub-Investigator: M. Ricardo Colella, MD         
Sub-Investigator: James B Gosset, MD         
Sub-Investigator: Brian Lewis, MD         
Sub-Investigator: Eric J. Hohenwalter, MD         
Sub-Investigator: Kellie R. Brown, MD         
Sub-Investigator: Peter Rossi, MD         
Sub-Investigator: Sarah B. White, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
McMaster University
Ontario Clinical Oncology Group (OCOG)
BSN Medical Inc
Genentech, Inc.
Covidien
Boston Scientific Corporation
Mid America Heart Institute
Society of Interventional Radiology Foundation
Massachusetts General Hospital
Investigators
Principal Investigator: Suresh Vedantham, M.D. Clinical Coordinating Center at Washington University School of Medicine
Principal Investigator: Clive Kearon, MB, MRCP, FRCP(C), PhD Data Coordinating Center at McMaster University-Ontario Clinical Oncology Group
Study Chair: Samuel Z Goldhaber, M.D. Brigham and Women's Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00790335     History of Changes
Other Study ID Numbers: 22326953211, U01 HL088476-01A1
Study First Received: October 15, 2008
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
deep vein thrombosis
deep venous thrombosis
post thrombotic syndrome
blood clot
thrombolysis
tissue plasminogen activator
rt-PA
Activase
mechanical thrombectomy
pharmacomechanical
ATTRACT

Additional relevant MeSH terms:
Postphlebitic Syndrome
Postthrombotic Syndrome
Syndrome
Thromboembolism
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Disease
Embolism and Thrombosis
Pathologic Processes
Peripheral Vascular Diseases
Phlebitis
Vascular Diseases
Venous Insufficiency
Plasminogen
Tissue Plasminogen Activator
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014