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

Completed

Phase 3 Results N/A

Update History

5 Apr '17
The gender criteria for eligibility was updated to "All."
1 Oct '15
The eligibility criteria were updated.
New
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).
Old
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).
19 Dec '14
A location was updated in Glendale.
New
The overall status was removed for Arrowhead Hospital/Phoenix Heart, PLLC.
A location was updated in Orange.
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The overall status was removed for St. Joseph Hospital.
A location was updated in Stanford.
New
The overall status was removed for Stanford University Medical Center.
A location was updated in Danbury.
New
The overall status was removed for Danbury Hospital.
A location was updated in Norwich.
New
The overall status was removed for Eastern Connecticut Hematology and Oncology Associates.
A location was updated in Newark.
New
The overall status was removed for Christiana Care Health Systems.
A location was updated in Washington.
New
The overall status was removed for Georgetown University Hospital.
A location was updated in Clearwater.
New
The overall status was removed for Mease Countryside Hospital.
A location was updated in Miami.
New
The overall status was removed for Baptist Cardiac & Vascular Institute.
A location was updated in Orlando.
New
The overall status was removed for Florida Hospital.
A location was updated in Tampa.
New
The overall status was removed for Florida Hospital-Tampa Division-Pepin Heart Institute and Dr. Kiran C. Patel Research Institute.
A location was updated in Chicago.
New
The overall status was removed for University of Illinois at Chicago.
A location was updated in Hinsdale.
New
The overall status was removed for Adventist Midwest Health.
A location was updated in Springfield.
New
The overall status was removed for Southern Illinois University.
A location was updated in Winfield.
New
The overall status was removed for Central Dupage Hospital.
A location was updated in Indianapolis.
New
The overall status was removed for CorVasc.
A location was updated in Iowa City.
New
The overall status was removed for University of Iowa Carver's College of Medicine.
A location was updated in Florence.
New
The overall status was removed for St. Elizabeth Healthcare of Northern Kentucky.
A location was updated in Portland.
New
The overall status was removed for Maine Medical Center.
A location was updated in Baltimore.
New
The overall status was removed for University of Maryland.
A location was updated in Boston.
New
The overall status was removed for Massachusetts General Hospital.
A location was updated in Ann Arbor.
New
The overall status was removed for Ann Arbor Veteran's Administration Health System.
A location was updated in Ann Arbor.
New
The overall status was removed for University of Michigan Medical Center.
A location was updated in Detroit.
New
The overall status was removed for Henry Ford Health System.
A location was updated in Minneapolis.
New
The overall status was removed for University of Minnesota.
A location was updated in Rochester.
New
The overall status was removed for Mayo Clinic.
A location was updated in Kansas City.
New
The overall status was removed for St. Luke's Hospital of Kansas City.
A location was updated in St. Louis.
New
The overall status was removed for Washington University School Of Medicine.
A location was updated in Lincoln.
New
The overall status was removed for Saint Elizabeth Regional Medical Center.
A location was updated in Teaneck.
New
The overall status was removed for Holy Name Hospital.
A location was updated in Albuquerque.
New
The overall status was removed for University of New Mexico.
A location was updated in New York.
New
The overall status was removed for Cornell Weill Medical Center.
A location was updated in Staten Island.
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The overall status was removed for Staten Island University Hospital.
A location was updated in Chapel Hill.
New
The overall status was removed for University of North Carolina at Chapel Hill.
A location was updated in Winston Salem.
New
The overall status was removed for Wake Forest University Baptist Medical Center.
A location was updated in Winston-Salem.
New
The overall status was removed for Forsyth Medical Center.
A location was updated in Cincinatti.
New
The overall status was removed for Good Samaritan Hospital.
A location was updated in Cleveland.
New
The overall status was removed for Cleveland Clinic.
A location was updated in Columbus.
New
The overall status was removed for Riverside Methodist Hospital.
A location was updated in Toledo.
New
The overall status was removed for Jobst Vascular Center.
A location was updated in Portland.
New
The overall status was removed for Oregon Health & Science University.
A location was updated in Bethlehem.
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The overall status was removed for St. Luke's Hospital and Health Network.
A location was updated in Philadelphia.
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The overall status was removed for Albert Einstein Medical Center.
A location was updated in Philadelphia.
New
The overall status was removed for Temple University Hospital.
A location was updated in Pittsburgh.
New
The overall status was removed for Allegheny General Hospital.
A location was updated in Pittsburgh.
New
The overall status was removed for The Western Pennsylvania Hospital.
A location was updated in Pittsburgh.
New
The overall status was removed for University of Pittsburgh Medical Center Presbyterian Shadyside.
A location was updated in West Reading.
New
The overall status was removed for The Reading Hospital and Medical Center.
A location was updated in Providence.
New
The overall status was removed for Rhode Island Hospital.
A location was updated in Charleston.
New
The overall status was removed for Medical University of South Carolina.
A location was updated in Dallas.
New
The overall status was removed for University of Texas Southwestern Medical Center.
A location was updated in Provo.
New
The overall status was removed for Utah Valley Regional Medical Center.
A location was updated in Salt Lake City.
New
The overall status was removed for University of Utah.
A location was updated in Charlottesville.
New
The overall status was removed for University of Virginia Health System.
A location was updated in Spokane.
New
The overall status was removed for Sacred Heart Medical Center.
A location was updated in Morgantown.
New
The overall status was removed for West Virginia University.
A location was updated in La Crosse.
New
The overall status was removed for Gundersen Clinic, Ltd..
A location was updated in Milwaukee.
New
The overall status was removed for Medical College of Wisconsin/Froedtert Hospital.
9 Sep '14
A location was updated in Washington.
New
The overall status was removed for Georgetown University Hospital.
A location was updated in Minneapolis.
New
The overall status was removed for University of Minnesota.
27 Aug '14
A location was updated in Charleston.
New
The overall status was removed for Medical University of South Carolina.
1 Aug '14
A location was updated in Philadelphia.
New
The overall status was removed for Albert Einstein Medical Center.
14 Jun '14
A location was updated in Winston-Salem.
New
The overall status was removed for Forsyth Medical Center.
15 Feb '14
A location was updated in Albuquerque.
New
The overall status was removed for University of New Mexico.
A location was updated in Columbus.
New
The overall status was removed for Riverside Methodist Hospital.
A location was updated in Dallas.
New
The overall status was removed for University of Texas Southwestern Medical Center.
6 Jul '13
A location was updated in Boston.
New
The overall status was removed for Massachusetts General Hospital.
A location was updated in Portland.
New
The overall status was removed for Oregon Health & Science University.
A location was updated in Salt Lake City.
New
The overall status was removed for University of Utah.
8 May '13
A location was updated in Miami.
New
The overall status was removed for Baptist Cardiac & Vascular Institute.
A location was updated in Springfield.
New
The overall status was removed for Southern Illinois University.
A location was updated in Minneapolis.
New
The overall status was removed for University of Minnesota.
A location was updated in Winston-Salem.
New
The overall status was removed for Forsyth Medical Center.
7 Nov '12
A location was updated in Staten Island.
New
The overall status was removed for Staten Island University Hospital.
3 Oct '12
A location was updated in Philadelphia.
New
The overall status was removed for Temple University Hospital.
21 Sep '12
The eligibility criteria were updated.
New
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).
Old
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 thienopryridine 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).
21 Jul '12
A location was updated in Clearwater.
New
The overall status was removed for Mease Countryside Hospital.
A location was updated in New York.
New
The overall status was removed for Cornell Weill Medical Center.
A location was updated in Provo.
New
The overall status was removed for Utah Valley Regional Medical Center.
A location was updated in Spokane.
New
The overall status was removed for Sacred Heart Medical Center.
4 May '12
A location was updated in Washington.
New
The overall status was removed for Georgetown University Hospital.
A location was updated in Florence.
New
The overall status was removed for St. Elizabeth Healthcare of Northern Kentucky.
A location was updated in Bethlehem.
New
The overall status was removed for St. Luke's Hospital and Health Network.
29 Mar '12
A location was updated in Cincinatti.
New
The overall status was removed for Good Samaritan Hospital.
28 Dec '11
A location was updated in Boston.
New
The overall status was updated to "Recruiting" at Massachesetts General Hospital.
A location was updated in Rochester.
New
The overall status was removed for Mayo Clinic.
A location was updated in Lincoln.
New
The overall status was removed for Saint Elizabeth Regional Medical Center.
A location was updated in Charleston.
New
The overall status was removed for Medical University of South Carolina.
4 Nov '11
A location was updated in Danbury.
New
The overall status was removed for Danbury Hospital.
A location was updated in Kansas City.
New
The overall status was removed for St. Luke's Hospital of Kansas City.
19 Oct '11
A location was updated in Orlando.
New
The overall status was removed for Florida Hospital.
A location was updated in Pittsburgh.
New
The overall status was removed for The Western Pennsylvania Hospital.