Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
ATTRACT
2 other identifiers
interventional
692
1 country
56
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2009
Longer than P75 for phase_3
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
March 29, 2018
CompletedMarch 29, 2018
February 1, 2018
7.2 years
October 15, 2008
December 18, 2017
February 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)
Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.
Between 6 and 24 months after randomization
Secondary Outcomes (26)
Major Non-post-thrombotic Syndrome Treatment Failure
Through 24 months
Any Treatment Failure
Through 24 months
Moderate-to-severe Post-thrombotic Syndrome
Between 6 and 24 months after randomization
Major Bleeding
Within 10 days after randomization
Major Bleeding
Within 24 months after randomization
- +21 more secondary outcomes
Study Arms (2)
A-Intervention
EXPERIMENTALPCDT 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
B-Control
NO INTERVENTIONInitial 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
Interventions
Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.
Eligibility Criteria
You may qualify if:
- Symptomatic proximal DVT involving the iliac, common femoral, and/or femoral vein.
You may not qualify if:
- 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.
- 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).
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- McMaster Universitycollaborator
- Ontario Clinical Oncology Group (OCOG)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- BSN Medical Inccollaborator
- Genentech, Inc.collaborator
- Medtronic - MITGcollaborator
- Boston Scientific Corporationcollaborator
- Mid America Heart Institutecollaborator
- Society of Interventional Radiology Foundationcollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (56)
Arrowhead Hospital/Phoenix Heart, PLLC
Glendale, Arizona, 85306, United States
St. Joseph Hospital
Orange, California, 92868, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Danbury Hospital
Danbury, Connecticut, 06810, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
Christiana Care Health Systems
Newark, Delaware, 19718, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Mease Countryside Hospital
Clearwater, Florida, 33761, United States
Baptist Cardiac & Vascular Institute
Miami, Florida, 33176, United States
Florida Hospital
Orlando, Florida, 32803, United States
Florida Hospital-Tampa Division-Pepin Heart Institute and Dr. Kiran C. Patel Research Institute
Tampa, Florida, 33613, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Adventist Midwest Health
Hinsdale, Illinois, United States
Southern Illinois University
Springfield, Illinois, 62702, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
CorVasc
Indianapolis, Indiana, 46260, United States
University of Iowa Carver's College of Medicine
Iowa City, Iowa, 52242, United States
St. Elizabeth Healthcare of Northern Kentucky
Florence, Kentucky, 41042, United States
Maine Medical Center
Portland, Maine, 04102, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Ann Arbor Veteran's Administration Health System
Ann Arbor, Michigan, 48105, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510-2494, United States
Holy Name Hospital
Teaneck, New Jersey, 07666, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Cornell Weill Medical Center
New York, New York, 10021, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7035, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Jobst Vascular Center
Toledo, Ohio, 43606, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center Presbyterian Shadyside
Pittsburgh, Pennsylvania, 15213, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
The Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Sacred Heart Medical Center
Spokane, Washington, 99204, United States
Gundersen Clinic, Ltd.
La Crosse, Wisconsin, 54601, United States
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Related Publications (14)
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.
PMID: 18574272BACKGROUNDKahn 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.
PMID: 16475040BACKGROUNDVedantham 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.
PMID: 16614142BACKGROUNDVedantham 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.
PMID: 15178716BACKGROUNDFlumignan 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.
PMID: 39968829DERIVEDLi 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.
PMID: 33445952DERIVEDKahn 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.
PMID: 31843251DERIVEDMagnuson 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.
PMID: 31592728DERIVEDWeinberg 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.
PMID: 31354089DERIVEDKearon 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.
PMID: 30699446DERIVEDComerota 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.
PMID: 30586751DERIVEDVedantham 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.
PMID: 29211671DERIVEDVedantham 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.
PMID: 23537968DERIVEDComerota 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.
PMID: 20047905DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Suresh Vedantham, Principal Investigator
- Organization
- Washington University in St. Louis
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2008
First Posted
November 13, 2008
Study Start
November 1, 2009
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
March 29, 2018
Results First Posted
March 29, 2018
Record last verified: 2018-02