Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
NCT ID: NCT00790335
Last Updated: 2018-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
692 participants
INTERVENTIONAL
2009-11-30
2017-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A-Intervention
PCDT with intrathrombus delivery of recombinant tissue plasminogen activator (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
Recombinant tissue plasminogen activator (rt-PA)
Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.
B-Control
Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target international normalized ratio 2.0 - 3.0). Elastic compression stockings will be prescribed
No interventions assigned to this group
Interventions
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Recombinant tissue plasminogen activator (rt-PA)
Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
* Pulmonary embolism 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 glomerular filtration rate \[GFR\] \< 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, cardiopulmonary resuscitation, 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).
16 Years
75 Years
ALL
No
Sponsors
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McMaster University
OTHER
Ontario Clinical Oncology Group (OCOG)
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
BSN Medical Inc
INDUSTRY
Genentech, Inc.
INDUSTRY
Medtronic - MITG
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Mid America Heart Institute
OTHER
Society of Interventional Radiology Foundation
OTHER
Massachusetts General Hospital
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Suresh Vedantham, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clinical Coordinating Center at Washington University School of Medicine
Clive Kearon, MB, MRCP, FRCP(C), PhD
Role: PRINCIPAL_INVESTIGATOR
Data Coordinating Center at McMaster University-Ontario Clinical Oncology Group
Samuel Z Goldhaber, M.D.
Role: STUDY_CHAIR
Brigham and Women's Hospital
Locations
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Arrowhead Hospital/Phoenix Heart, PLLC
Glendale, Arizona, United States
St. Joseph Hospital
Orange, California, United States
Stanford University Medical Center
Stanford, California, United States
Danbury Hospital
Danbury, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Christiana Care Health Systems
Newark, Delaware, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Mease Countryside Hospital
Clearwater, Florida, United States
Baptist Cardiac & Vascular Institute
Miami, Florida, United States
Florida Hospital
Orlando, Florida, United States
Florida Hospital-Tampa Division-Pepin Heart Institute and Dr. Kiran C. Patel Research Institute
Tampa, Florida, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Adventist Midwest Health
Hinsdale, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
Central DuPage Hospital
Winfield, Illinois, United States
CorVasc
Indianapolis, Indiana, United States
University of Iowa Carver's College of Medicine
Iowa City, Iowa, United States
St. Elizabeth Healthcare of Northern Kentucky
Florence, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Ann Arbor Veteran's Administration Health System
Ann Arbor, Michigan, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, United States
Holy Name Hospital
Teaneck, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Cornell Weill Medical Center
New York, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Jobst Vascular Center
Toledo, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
The Reading Hospital and Medical Center
West Reading, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Sacred Heart Medical Center
Spokane, Washington, United States
Gundersen Clinic, Ltd.
La Crosse, Wisconsin, United States
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States
Countries
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References
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Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):454S-545S. doi: 10.1378/chest.08-0658.
Kahn SR. The post-thrombotic syndrome: the forgotten morbidity of deep venous thrombosis. J Thromb Thrombolysis. 2006 Feb;21(1):41-8. doi: 10.1007/s11239-006-5574-9.
Vedantham S, Millward SF, Cardella JF, Hofmann LV, Razavi MK, Grassi CJ, Sacks D, Kinney TB; Society of Interventional Radiology. Society of Interventional Radiology position statement: treatment of acute iliofemoral deep vein thrombosis with use of adjunctive catheter-directed intrathrombus thrombolysis. J Vasc Interv Radiol. 2006 Apr;17(4):613-6. doi: 10.1097/01.RVI.0000203802.35689.66. No abstract available.
Vedantham S, Vesely TM, Sicard GA, Brown D, Rubin B, Sanchez LA, Parti N, Picus D. Pharmacomechanical thrombolysis and early stent placement for iliofemoral deep vein thrombosis. J Vasc Interv Radiol. 2004 Jun;15(6):565-74. doi: 10.1097/01.rvi.0000127894.00553.02.
Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
Li W, Kessinger CW, Orii M, Lee H, Wang L, Weinberg I, Jaff MR, Reed GL, Libby P, Tawakol A, Henke PK, Jaffer FA. Time-Restricted Salutary Effects of Blood Flow Restoration on Venous Thrombosis and Vein Wall Injury in Mouse and Human Subjects. Circulation. 2021 Mar 23;143(12):1224-1238. doi: 10.1161/CIRCULATIONAHA.120.049096. Epub 2021 Jan 15.
Kahn SR, Julian JA, Kearon C, Gu CS, Cohen DJ, Magnuson EA, Comerota AJ, Goldhaber SZ, Jaff MR, Razavi MK, Kindzelski AL, Schneider JR, Kim P, Chaer R, Sista AK, McLafferty RB, Kaufman JA, Wible BC, Blinder M, Vedantham S; ATTRACT Trial Investigators. Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2020 Jan;8(1):8-23.e18. doi: 10.1016/j.jvsv.2019.03.023.
Magnuson EA, Chinnakondepalli K, Vilain K, Kearon C, Julian JA, Kahn SR, Goldhaber SZ, Jaff MR, Kindzelski AL, Herman K, Brady PS, Sharma K, Black CM, Vedantham S, Cohen DJ. Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial. Circ Cardiovasc Qual Outcomes. 2019 Oct;12(10):e005659. doi: 10.1161/CIRCOUTCOMES.119.005659. Epub 2019 Oct 8.
Weinberg I, Vedantham S, Salter A, Hadley G, Al-Hammadi N, Kearon C, Julian JA, Razavi MK, Gornik HL, Goldhaber SZ, Comerota AJ, Kindzelski AL, Schainfeld RM, Angle JF, Misra S, Schor JA, Hurst D, Jaff MR; ATTRACT Trial Investigators. Relationships between the use of pharmacomechanical catheter-directed thrombolysis, sonographic findings, and clinical outcomes in patients with acute proximal DVT: Results from the ATTRACT Multicenter Randomized Trial. Vasc Med. 2019 Oct;24(5):442-451. doi: 10.1177/1358863X19862043. Epub 2019 Jul 27.
Kearon C, Gu CS, Julian JA, Goldhaber SZ, Comerota AJ, Gornik HL, Murphy TP, Lewis L, Kahn SR, Kindzelski AL, Slater D, Geary R, Winokur R, Natarajan K, Dietzek A, Leung DA, Kim S, Vedantham S. Pharmacomechanical Catheter-Directed Thrombolysis in Acute Femoral-Popliteal Deep Vein Thrombosis: Analysis from a Stratified Randomized Trial. Thromb Haemost. 2019 Apr;119(4):633-644. doi: 10.1055/s-0039-1677795. Epub 2019 Jan 30.
Comerota AJ, Kearon C, Gu CS, Julian JA, Goldhaber SZ, Kahn SR, Jaff MR, Razavi MK, Kindzelski AL, Bashir R, Patel P, Sharafuddin M, Sichlau MJ, Saad WE, Assi Z, Hofmann LV, Kennedy M, Vedantham S; ATTRACT Trial Investigators. Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis. Circulation. 2019 Feb 26;139(9):1162-1173. doi: 10.1161/CIRCULATIONAHA.118.037425.
Vedantham S, Goldhaber SZ, Julian JA, Kahn SR, Jaff MR, Cohen DJ, Magnuson E, Razavi MK, Comerota AJ, Gornik HL, Murphy TP, Lewis L, Duncan JR, Nieters P, Derfler MC, Filion M, Gu CS, Kee S, Schneider J, Saad N, Blinder M, Moll S, Sacks D, Lin J, Rundback J, Garcia M, Razdan R, VanderWoude E, Marques V, Kearon C; ATTRACT Trial Investigators. Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis. N Engl J Med. 2017 Dec 7;377(23):2240-2252. doi: 10.1056/NEJMoa1615066.
Vedantham S, Goldhaber SZ, Kahn SR, Julian J, Magnuson E, Jaff MR, Murphy TP, Cohen DJ, Comerota AJ, Gornik HL, Razavi MK, Lewis L, Kearon C. Rationale and design of the ATTRACT Study: a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis. Am Heart J. 2013 Apr;165(4):523-530.e3. doi: 10.1016/j.ahj.2013.01.024. Epub 2013 Mar 5.
Comerota AJ. The ATTRACT trial: rationale for early intervention for iliofemoral DVT. Perspect Vasc Surg Endovasc Ther. 2009 Dec;21(4):221-4; quiz 224-5. doi: 10.1177/1531003509359311. Epub 2010 Jan 3.
Related Links
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Deep Vein Thrombosis
Other Identifiers
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22326953211
Identifier Type: -
Identifier Source: org_study_id
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