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

Primary Purpose

Deep Vein Thrombosis, Venous Thrombosis, Postphlebitic Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Recombinant tissue plasminogen activator (rt-PA)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring deep vein thrombosis, deep venous thrombosis, post thrombotic syndrome, blood clot, thrombolysis, tissue plasminogen activator, rt-PA, Activase, mechanical thrombectomy, pharmacomechanical, ATTRACT

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
  • 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).

Sites / Locations

  • Arrowhead Hospital/Phoenix Heart, PLLC
  • St. Joseph Hospital
  • Stanford University Medical Center
  • Danbury Hospital
  • Eastern Connecticut Hematology and Oncology Associates
  • Christiana Care Health Systems
  • Georgetown University Hospital
  • Mease Countryside Hospital
  • Baptist Cardiac & Vascular Institute
  • Florida Hospital
  • Florida Hospital-Tampa Division-Pepin Heart Institute and Dr. Kiran C. Patel Research Institute
  • University of Illinois at Chicago
  • Adventist Midwest Health
  • Southern Illinois University
  • Central DuPage Hospital
  • CorVasc
  • University of Iowa Carver's College of Medicine
  • St. Elizabeth Healthcare of Northern Kentucky
  • Maine Medical Center
  • University of Maryland
  • Massachusetts General Hospital
  • Ann Arbor Veteran's Administration Health System
  • University of Michigan Medical Center
  • Henry Ford Health System
  • University of Minnesota
  • Mayo Clinic
  • St. Luke's Hospital of Kansas City
  • Washington University School of Medicine
  • Saint Elizabeth Regional Medical Center
  • Holy Name Hospital
  • University of New Mexico
  • Cornell Weill Medical Center
  • Staten Island University Hospital
  • University of North Carolina at Chapel Hill
  • Forsyth Medical Center
  • Wake Forest University Baptist Medical Center
  • Good Samaritan Hospital
  • Cleveland Clinic
  • Riverside Methodist Hospital
  • Jobst Vascular Center
  • Oregon Health & Science University
  • St. Luke's Hospital and Health Network
  • Albert Einstein Medical Center
  • Temple University Hospital
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center Presbyterian Shadyside
  • The Western Pennsylvania Hospital
  • The Reading Hospital and Medical Center
  • Rhode Island Hospital
  • Medical University of South Carolina
  • Utah Valley Regional Medical Center
  • University of Utah
  • University of Virginia Health System
  • Sacred Heart Medical Center
  • Gundersen Clinic, Ltd.
  • Medical College of Wisconsin/Froedtert Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A-Intervention

B-Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Major Non-post-thrombotic Syndrome Treatment Failure
A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months.
Any Treatment Failure
Composite of PTS and major non-PTS treatment failure
Moderate-to-severe Post-thrombotic Syndrome
Proportion of patients with Villalta score of 10 or higher at any time between the 6 month and 24 month follow-up visits, inclusive. The Villalta scale ranges from 0-33 points, with higher scores being worse.
Major Bleeding
Defined as clinically overt bleeding that is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).
Major Bleeding
Defined as clinically overt bleeding that was associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).
Any (Minor + Major) Bleeding
Clinically overt bleeding that occurred through 10 days post-randomization
Any (Major + Minor) Bleeding
Clinically overt bleeding that occurred within 24 months post-randomization
Recurrent Venous Thromboembolism
Proportion of patients with symptomatic recurrent venous thromboembolism (including DVT and/or PE)
Recurrent Venous Thromboembolism
Symptomatic recurrent venous thromboembolism (DVT and/or PE)
Death
All-cause mortality
Death
All-cause mortality
Severity of Post-thrombotic Syndrome (Villalta)
Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Severity of Post-thrombotic Syndrome (Villalta)
Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Severity of Post-thrombotic Syndrome (Villalta)
Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Severity of Post-thrombotic Syndrome (Villalta)
Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Venous Clinical Severity Score
Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse
Venous Clinical Severity Score
Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Venous Clinical Severity Score
Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Venous Clinical Severity Score
Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Change in General Quality of Life - Physical
Short-Form-36 Health Survey, Version 2, Physical Component Summary (PCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.
Change in General Quality of Life - Mental
Short-Form-36 Health Survey, Version 2, Mental Component Summary (MCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.
Change in Venous Disease-specific Quality of Life
Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire. Range of scores 0-100 with higher scores representing better quality of life, and higher change scores representing greater improvement from baseline.
Change in Leg Pain Severity
Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain
Change in Leg Pain Severity
Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain
Change in Leg Circumference
Mean calf circumference measured 10 cm below the tibial tuberosity
Change in Leg Circumference
Mean calf circumference measured 10 cm below the tibial tuberosity

Full Information

First Posted
October 15, 2008
Last Updated
February 28, 2018
Sponsor
Washington University School of Medicine
Collaborators
McMaster University, Ontario Clinical Oncology Group (OCOG), National Heart, Lung, and Blood Institute (NHLBI), BSN Medical Inc, Genentech, Inc., Medtronic - MITG, Boston Scientific Corporation, Mid America Heart Institute, Society of Interventional Radiology Foundation, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00790335
Brief Title
Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
Acronym
ATTRACT
Official Title
Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
McMaster University, Ontario Clinical Oncology Group (OCOG), National Heart, Lung, and Blood Institute (NHLBI), BSN Medical Inc, Genentech, Inc., Medtronic - MITG, Boston Scientific Corporation, Mid America Heart Institute, Society of Interventional Radiology Foundation, Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Venous Thrombosis, Postphlebitic Syndrome, Venous Thromboembolism, Post Thrombotic Syndrome
Keywords
deep vein thrombosis, deep venous thrombosis, post thrombotic syndrome, blood clot, thrombolysis, tissue plasminogen activator, rt-PA, Activase, mechanical thrombectomy, pharmacomechanical, ATTRACT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
692 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
B-Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Recombinant tissue plasminogen activator (rt-PA)
Other Intervention Name(s)
rt-PA, recombinant tissue plasminogen activator, Activase, Alteplase
Intervention Description
Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.
Primary Outcome Measure Information:
Title
Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)
Description
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.
Time Frame
Between 6 and 24 months after randomization
Secondary Outcome Measure Information:
Title
Major Non-post-thrombotic Syndrome Treatment Failure
Description
A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months.
Time Frame
Through 24 months
Title
Any Treatment Failure
Description
Composite of PTS and major non-PTS treatment failure
Time Frame
Through 24 months
Title
Moderate-to-severe Post-thrombotic Syndrome
Description
Proportion of patients with Villalta score of 10 or higher at any time between the 6 month and 24 month follow-up visits, inclusive. The Villalta scale ranges from 0-33 points, with higher scores being worse.
Time Frame
Between 6 and 24 months after randomization
Title
Major Bleeding
Description
Defined as clinically overt bleeding that is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).
Time Frame
Within 10 days after randomization
Title
Major Bleeding
Description
Defined as clinically overt bleeding that was associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).
Time Frame
Within 24 months after randomization
Title
Any (Minor + Major) Bleeding
Description
Clinically overt bleeding that occurred through 10 days post-randomization
Time Frame
Within 10 days after randomization
Title
Any (Major + Minor) Bleeding
Description
Clinically overt bleeding that occurred within 24 months post-randomization
Time Frame
Within 24 months after randomization
Title
Recurrent Venous Thromboembolism
Description
Proportion of patients with symptomatic recurrent venous thromboembolism (including DVT and/or PE)
Time Frame
Within 10 days after randomization
Title
Recurrent Venous Thromboembolism
Description
Symptomatic recurrent venous thromboembolism (DVT and/or PE)
Time Frame
Within 24 months after randomization
Title
Death
Description
All-cause mortality
Time Frame
Within 10 days after randomization
Title
Death
Description
All-cause mortality
Time Frame
Within 24 months after randomization
Title
Severity of Post-thrombotic Syndrome (Villalta)
Description
Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Time Frame
At 6 months
Title
Severity of Post-thrombotic Syndrome (Villalta)
Description
Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Time Frame
At 12 months
Title
Severity of Post-thrombotic Syndrome (Villalta)
Description
Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Time Frame
At 18 months
Title
Severity of Post-thrombotic Syndrome (Villalta)
Description
Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Time Frame
At 24 months
Title
Venous Clinical Severity Score
Description
Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse
Time Frame
At 6 months
Title
Venous Clinical Severity Score
Description
Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Time Frame
At 12 months
Title
Venous Clinical Severity Score
Description
Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Time Frame
At 18 months
Title
Venous Clinical Severity Score
Description
Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Time Frame
At 24 months
Title
Change in General Quality of Life - Physical
Description
Short-Form-36 Health Survey, Version 2, Physical Component Summary (PCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.
Time Frame
Baseline to 24 months post-randomization
Title
Change in General Quality of Life - Mental
Description
Short-Form-36 Health Survey, Version 2, Mental Component Summary (MCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.
Time Frame
Baseline to 24 months post-randomization
Title
Change in Venous Disease-specific Quality of Life
Description
Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire. Range of scores 0-100 with higher scores representing better quality of life, and higher change scores representing greater improvement from baseline.
Time Frame
Baseline to 24 months post-randomization
Title
Change in Leg Pain Severity
Description
Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain
Time Frame
Baseline to 10 days post-randomization
Title
Change in Leg Pain Severity
Description
Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain
Time Frame
Baseline to 30 days post-randomization
Title
Change in Leg Circumference
Description
Mean calf circumference measured 10 cm below the tibial tuberosity
Time Frame
Baseline to 10 days post-randomization
Title
Change in Leg Circumference
Description
Mean calf circumference measured 10 cm below the tibial tuberosity
Time Frame
Baseline to 30 days post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suresh Vedantham, M.D.
Organizational Affiliation
Clinical Coordinating Center at Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clive Kearon, MB, MRCP, FRCP(C), PhD
Organizational Affiliation
Data Coordinating Center at McMaster University-Ontario Clinical Oncology Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel Z Goldhaber, M.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Arrowhead Hospital/Phoenix Heart, PLLC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
St. Joseph Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Eastern Connecticut Hematology and Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Christiana Care Health Systems
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Mease Countryside Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Baptist Cardiac & Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Florida Hospital-Tampa Division-Pepin Heart Institute and Dr. Kiran C. Patel Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Adventist Midwest Health
City
Hinsdale
State/Province
Illinois
Country
United States
Facility Name
Southern Illinois University
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
CorVasc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Iowa Carver's College of Medicine
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
St. Elizabeth Healthcare of Northern Kentucky
City
Florence
State/Province
Kentucky
ZIP/Postal Code
41042
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Ann Arbor Veteran's Administration Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Saint Elizabeth Regional Medical Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510-2494
Country
United States
Facility Name
Holy Name Hospital
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Cornell Weill Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7035
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Jobst Vascular Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
St. Luke's Hospital and Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center Presbyterian Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
The Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
The Reading Hospital and Medical Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Utah Valley Regional Medical Center
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Gundersen Clinic, Ltd.
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Medical College of Wisconsin/Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18574272
Citation
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. Erratum In: Chest. 2008 Oct;134(4):892.
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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.
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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.
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Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
31843251
Citation
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.
Results Reference
derived
PubMed Identifier
31592728
Citation
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.
Results Reference
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PubMed Identifier
31354089
Citation
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.
Results Reference
derived
PubMed Identifier
30699446
Citation
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.
Results Reference
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PubMed Identifier
30586751
Citation
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.
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29211671
Citation
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.
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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.
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Citation
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.
Results Reference
derived
Links:
URL
http://www.patient.co.uk/showdoc/23068982
Description
Deep Vein Thrombosis

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

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