Text Size
Trial record 1 of 27 for:    ATTRACT
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
Verified May 2013 by Washington University School of Medicine
Sponsor:
Collaborators:
McMaster University
Ontario Clinical Oncology Group (OCOG)
National Heart, Lung, and Blood Institute (NHLBI)
BSN Medical Inc
Genentech
Covidien
BayerHealthcare
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: May 17, 2013
Last verified: May 2013
History of Changes
  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:

Drug Information available for: Alteplase
U.S. FDA Resources

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
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: Marvin B Padnick, MD, FACP, FACC            
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            
Sub-Investigator: Melissa B Gurley, MD            
United States, California
St. Joseph Hospital Recruiting
Orange, California, United States, 92868
Contact: Gemma Miralles, RN     714-744-8776     gemma.miralles@stjoe.org    
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: Howard Dorne, M.D.            
Sub-Investigator: D. Preston Flanigan, M.D.            
Sub-Investigator: Michael Chan, MD            
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Kamil Unver     650-725-9810     kunver@stanfordmedcenter.org    
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 Active, not recruiting
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.            
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: Stefanie Miller     630-933-6254     Stefanie_Miller@cdh.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: Stewart Bick, MD            
Sub-Investigator: Ann Hedderman, MD            
Sub-Investigator: Anne Greist, MD            
Sub-Investigator: Lori Miller-Rice, 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    
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 Recruiting
Boston, Massachusetts, United States, 02114
Contact: Connie Crittenden, RN         CCRITTENDEN@PARTNERS.ORG    
Contact: Deb O'Shaughnessy         doshaughnessy@partners.org    
Sub-Investigator: Stephan Wicky, MD            
Sub-Investigator: Sanjeeva P Kalva, MD            
Sub-Investigator: Gloria M Salazar, MD            
Principal Investigator: Robert P Schainfeld, DO            
Sub-Investigator: Thomas G Walker, MD            
Sub-Investigator: Virendra I Patel, MD            
Sub-Investigator: Christopher Kabrhel, MD            
Sub-Investigator: Rahmi Oklu, M.D.            
Sub-Investigator: Suvranu Ganguli, M.D.            
Sub-Investigator: Scott Brannan, M.D.            
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: Jonathan L Eliason, MD            
Sub-Investigator: Peter K Henke, MD            
Sub-Investigator: John E Rectenwald, MD            
Sub-Investigator: David Williams, MD            
Sub-Investigator: Guillermo Escobar, 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            
United States, Minnesota
University of Minnesota Completed
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 Recruiting
Albuquerque, New Mexico, United States, 87131
Principal Investigator: John Marek, MD            
Sub-Investigator: David Garcia, MD            
Sub-Investigator: Isaac Tawil, MD            
Sub-Investigator: Mark Langsfeld, MD            
United States, New York
Cornell Weill Medical Center Recruiting
New York, New York, United States, 10021
Contact: Alexandra Kotsovos         alk9065@med.cornell.edu    
Contact: Miriam Abu     212-746-9748     maa2072@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            
Staten Island University Hospital Recruiting
Staten Island, New York, United States, 10305
Contact: Gabriella Taflin, RN     718-226-9143     gabriella.taflin@gmail.com    
Contact: Maria Scibilia, RN     718-226-6256     maria.c.scibilia@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    
Contact: William Simmons         simmonsw@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 Active, not recruiting
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 Recruiting
Columbus, Ohio, United States, 43214
Contact: Mindie Taylor, RN     614-566-1255     mtaylor8@ohiohealth.com    
Contact: Nancy Sample, RN     614-566-1267     nsample@ohiohealth.com    
Principal Investigator: Sumit Bhatla, MD            
Sub-Investigator: Darick Jacobs, MD            
Sub-Investigator: Eric Dolen, MD            
Sub-Investigator: Jeffrey Silber, MD            
Sub-Investigator: Donald Wood, MD            
Sub-Investigator: Pablo Gamboa, MD            
Sub-Investigator: Brian Schirf, MD            
Sub-Investigator: J. Kevin McGraw, MD            
Sub-Investigator: L. Mark Dean, MD            
Sub-Investigator: John Lippert, MD            
Sub-Investigator: Lucy LaPerna, DO            
Sub-Investigator: Thomas Davis, MD            
Sub-Investigator: Sanjeev Khanna, MD            
Sub-Investigator: Paul Willette, DO            
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 Recruiting
Portland, Oregon, United States, 97239
Contact: Lori L. Russell, RN, CCRP     503-494-7226     watsonlo@ohsu.edu    
Principal Investigator: John A. Kaufman, MD            
Sub-Investigator: Thomas Deloughery, MD            
Sub-Investigator: Gregory Moneta, MD            
Sub-Investigator: Greg Landry, MD            
Sub-Investigator: Timothy Liem, MD            
Sub-Investigator: Erica Mitchell, MD            
Sub-Investigator: Rob Barton, MD            
Sub-Investigator: Ken Kolbeck, MD            
Sub-Investigator: Frederick Keller, MD            
Sub-Investigator: Khashayar Farsad, M.D.            
Sub-Investigator: Ross Fleischman, M.D.            
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: Robert D. Reinhart, M.D.            
Sub-Investigator: Ellen A. Redstone, M.D.            
Sub-Investigator: Bengt L. Ivarsson, M.D.            
Sub-Investigator: Justin P. Psaila, M.D.            
Sub-Investigator: Jonathan L. Shingles, M.D.            
Sub-Investigator: Amy L. Lipscomb, M.D.            
Albert Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Jenna Wald     215-456-6370     waldj@einstein.edu    
Principal Investigator: Paul Brady, M.D.            
Sub-Investigator: Terence A.S. Matalon, M.D.            
Sub-Investigator: Marvin Schatz, D.O.            
Sub-Investigator: Mindy Horrow, M.D.            
Sub-Investigator: Peyman Markazi, DO            
Sub-Investigator: Joshua E. Markowitz, MD            
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States
Contact: Jenny Wong, RN     217-707-5340     wongjk@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.            
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: Suzanne David, RN     412-623-8443     DavidS@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.            
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    
Principal Investigator: Margaret Kennedy, MD            
Sub-Investigator: Gordon K. McLean, MD            
Sub-Investigator: Robert Kaplan, M.D.            
Sub-Investigator: Sanualah Khalid, 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    
Principal Investigator: Margaret Kennedy, MD            
Sub-Investigator: Robert Kaplan, MD            
Sub-Investigator: Gordon McLean, MD            
Sub-Investigator: Arvind Venkat, M.D.            
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: Paul Jordan, MA     401-444-6208     pjordan@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: Abdel Jaffan, MD            
Sub-Investigator: Christopher Hampson, MD            
Sub-Investigator: Aaron Frodsham, M.D.            
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Tina Cooper         cooperti@musc.edu    
Principal Investigator: Marcelo Guimaraes, MD            
Sub-Investigator: Charles Greenberg, MD            
Sub-Investigator: Claudio Schonholz, MD            
Sub-Investigator: J. Bayne Selby, MD            
Sub-Investigator: Christopher Hannegan, MD            
Sub-Investigator: William McGary, MD            
Sub-Investigator: Bruce Elliott, MD            
Sub-Investigator: Jacob Robison, MD            
Sub-Investigator: Thomas Brothers, MD            
United States, Utah
Utah Valley Regional Medical Center Active, not recruiting
Provo, Utah, United States, 84604
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Maria Maloney     801-585-3663     maria.maloney@hsc.utah.edu    
Principal Investigator: Russell Vinik, MD            
Sub-Investigator: Andrew L. Freeman, MD            
Sub-Investigator: Dan Kinikini, MD            
Sub-Investigator: Larry Kraiss, MD            
Sub-Investigator: Michelle Mueller, MD            
Sub-Investigator: Robert C. Pendleton, MD            
Sub-Investigator: Matthew T. Rondina, MD            
Sub-Investigator: Mark Sarfati, MD            
Sub-Investigator: Nathan A. Wanner, MD            
Sub-Investigator: Stacy Johnson, MD            
Sub-Investigator: Christy Hopkins-McGowan, MD            
Sub-Investigator: Daniel Ihnat, M.D.            
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: Wael Saad, 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.            
United States, Washington
Sacred Heart Medical Center Active, not recruiting
Spokane, Washington, United States, 99204
United States, Wisconsin
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: Gary S Seabrook, 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)
National Heart, Lung, and Blood Institute (NHLBI)
BSN Medical Inc
Genentech
Covidien
BayerHealthcare
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:
The Long-Term Clinical Course of Acute Deep Vein Thrombosis  This link exits the ClinicalTrials.gov site
Predictors of the Post Thrombotic Syndrome During Long-Term Treatment of Proximal Deep Vein Thrombosis  This link exits the ClinicalTrials.gov site
Deep Vein Thrombosis  This link exits the ClinicalTrials.gov site
Below-Knee Elastic Compression Stockings to Prevent the Post Thrombotic Syndrome  This link exits the ClinicalTrials.gov site

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: May 17, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 19, 2013