Back to resultsCatheter-directed Thrombolysis Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis
Primary Purpose
Deep Venous Thrombosis, Post Thrombotic Syndrome
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Catheter directed thrombolysis plus anticoagulation
Anticoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Deep Venous Thrombosis
Eligibility Criteria
Inclusion Criteria:
- Age>18 and younger than 75
- Symptomatic, proximal deep-vein thrombosis involving the Iliofemoral vein from 12/01/2019 to 12/01/2022
Exclusion Criteria:
- Age less than 18 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 popliteal and/or tibial veins; or b) for which thrombolysis is planned as part of 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 months) GI bleeding, severe liver dysfunction, bleeding diathesis.
- Recent (< 3 months) 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 > 180mmHg or diastolic > 105 mmHg).
- Pregnant (positive pregnancy test, women of childbearing potential must be tested).
- Recently (< 2 years or chronic non-ambulatory status.
- 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).
Sites / Locations
- University of Toledo Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pharmacomechanical thrombolysis plus anticoagulation
Anticoagulation
Arm Description
This group of patients will receive Pharmacomechanical catheter-directed thrombolysis (PCDT) plus Anticoagulation. PCDT will be AngioJet along with alteplase. Anticoagulation will be heparin only
This group of patients will receive standard anticoagulation only. Anticoagulation will be Heparin only
Outcomes
Primary Outcome Measures
Post-thrombotic syndrome at any time between 6-month and 24-month.
Occurrence of post-thrombotic syndrome at any time between 6-month and 24-month after procedure by Villata score (Villata score >5 or more), or if patient underwent an unplanned endovascular procedure to treat venous symptoms.
The variables in villata scores are pain, cramps, heaviness, parasthesia, pruritus, pretibial edema, skin induration, hyperpigmentation, pain during calf compression, venous ectasia and redness.
The Villata score ranges 0-45. Villata score <5 means no post-thrombotic syndrome. Villata score 5-9 mild post-thrombotic syndrome. Villata score 10-14 means moderate post-thrombotic syndrome. Villata score ≥15 or presence of an ulcer indicates severe post-thrombotic syndrome.
The more is the score the worse is the disease.
Secondary Outcome Measures
Post-thrombotic syndrome at 6 months.
Occurrence of post-thrombotic syndrome at 6 months measured by Villata score (Villalta score was 5 or higher).
Post-thrombotic syndrome at 12 months.
Occurrence of post-thrombotic syndrome at 12 months measured by Villata score (Villalta score was 5 or higher).
Post-thrombotic syndrome at 18 months.
Occurrence of post-thrombotic syndrome at 18 months measured by Villata score (Villalta score was 5 or higher).
Post-thrombotic syndrome at 24 months.
Occurrence of post-thrombotic syndrome at 24 months measured by Villata score (Villalta score was 5 or higher).
Villalta scale at 6 months
The severity of the post-thrombotic syndrome to be evaluated at 6 months with the use of the Villalta scale
Villalta scale at 12 months
The severity of the post-thrombotic syndrome to be evaluated at 12 months with the use of the Villalta scale.
Villalta scale at 18 months
The severity of the post-thrombotic syndrome to be evaluated at 18 months with the use of the Villalta scale.
Villalta scale at 24 months
The severity of the post-thrombotic syndrome to be evaluated at 18 months with the use of the Villalta scale.
Venous Clinical Severity Score at 6 months
The severity of the post-thrombotic syndrome to be evaluated at 6 months with the use of the Venous Clinical Severity Score.
Venous Clinical Severity Score at 12 months
The severity of the post-thrombotic syndrome to be evaluated at 12 months with the use of the Venous Clinical Severity Score.
Venous Clinical Severity Score at 18 months
The severity of the post-thrombotic syndrome to be evaluated at 18 months with the use of the Venous Clinical Severity Score.
Venous Clinical Severity Score at 24 months
The severity of the post-thrombotic syndrome to be evaluated at 24 months with the use of the Venous Clinical Severity Score.
Health-Related Quality of Life AT 6 months
Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life
Health-Related Quality of Life at 12 months.
Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life at 12 months.
Health-Related Quality of Life at 18 months.
Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life at 18 months.
Health-Related Quality of Life at 24 months.
Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life at 24 months.
Health-Related Quality of Life at 6 months.
Health-Related Quality of Life measured by Generic Quality of Life at 6 months.
Health-Related Quality of Life at 12 months.
Health-Related Quality of Life measured by Generic Quality of Life at 12 months
Health-Related Quality of Life at 18 months.
Health-Related Quality of Life measured by Generic Quality of Life at 18 months.
Health-Related Quality of Life at 24 months.
Health-Related Quality of Life measured by Generic Quality of Life at 24 months.
Health-Related Quality of Life at 6 months.
Health-Related Quality of Life measured by Administration of QOL Measures at 6 months.
Health-Related Quality of Life at 12 months.
Health-Related Quality of Life measured by Administration of QOL Measures at 12 months.
Health-Related Quality of Life at 18 months.
Health-Related Quality of Life measured by Administration of QOL Measures at 18 months.
Health-Related Quality of Life at 24 months.
Health-Related Quality of Life measured by Administration of QOL Measures at 24 months.
Treatment Failures that are Not PTS.
Treatment Failures that are Not PTS (defined as one or more of the following during the 24 months post randomization: 1) the patient underwent an unplanned endovascular or surgical intervention for the treatment of severe symptomatic venous disease in the index leg within the first 24 months after randomization (2) the subject underwent an amputation in the index leg anytime within 24 months after randomization; or (3) the subject developed venous gangrene in the index leg within the first 24 months after randomization.
Severity of presenting DVT Symptoms at 6 months
Severity of presenting DVT Symptoms (Leg pain severity measured by pain scale) at 6 months
Severity of presenting DVT Symptoms at 12 months
Severity of presenting DVT Symptoms (Leg pain severity measured by pain scale) at 12 months
Severity of presenting DVT Symptoms at 18 months
Severity of presenting DVT Symptoms (Leg pain severity measured by pain scale) at 18 months
Severity of presenting DVT Symptoms at 24 months
Severity of presenting DVT Symptoms (Leg pain severity measured by pain scale) at 24 months
Severity of presenting DVT Symptoms at 6 months
Severity of presenting DVT Symptoms (Leg swelling measured by measuring calf swelling) at 6 months
Severity of presenting DVT Symptoms at 12 months
Severity of presenting DVT Symptoms (Leg swelling measured by measuring calf swelling) at 12 months
Severity of presenting DVT Symptoms at 18 months
Severity of presenting DVT Symptoms (Leg swelling measured by measuring calf swelling) at 18 months
Severity of presenting DVT Symptoms at 24 months
Severity of presenting DVT Symptoms (Leg swelling measured by measuring calf swelling) at 24 months
Degree of Resolution of Thrombus with PCDT at 6 months.
Degree of Resolution of Thrombus with PCDT (Assessed by two sets of venograms in PCDT arm, one baseline venogram of the proximal veins (popliteal vein through infrarenal IVC) obtained after initial catheter insertion into the venous system before PCDT; and one the final venogram of the proximal veins obtained after PCDT and any adjunctive procedures, before sheath removal. Marder score will be used to quantify clot burden. Marder score range 0-24, with 0 representing no thrombus and 24 representing complete thrombosis). The degree of thrombus elimination (% change in pre-PCDT and post-PCDT Marder score) will be calculated.
Degree of Resolution of Thrombus with PCDT at 12 months.
Degree of Resolution of Thrombus with PCDT (Assessed by two sets of venograms in PCDT arm, one baseline venogram of the proximal veins (popliteal vein through infrarenal IVC) obtained after initial catheter insertion into the venous system before PCDT; and one the final venogram of the proximal veins obtained after PCDT and any adjunctive procedures, before sheath removal. Marder score will be used to quantify clot burden. Marder score range 0-24, with 0 representing no thrombus and 24 representing complete thrombosis). The degree of thrombus elimination (% change in pre-PCDT and post-PCDT Marder score) will be calculated.
Degree of Resolution of Thrombus with PCDT at 18 months.
Degree of Resolution of Thrombus with PCDT (Assessed by two sets of venograms in PCDT arm, one baseline venogram of the proximal veins (popliteal vein through infrarenal IVC) obtained after initial catheter insertion into the venous system before PCDT; and one the final venogram of the proximal veins obtained after PCDT and any adjunctive procedures, before sheath removal. Marder score will be used to quantify clot burden. Marder score range 0-24, with 0 representing no thrombus and 24 representing complete thrombosis). The degree of thrombus elimination (% change in pre-PCDT and post-PCDT Marder score) will be calculated.
Degree of Resolution of Thrombus with PCDT at 24 months.
Degree of Resolution of Thrombus with PCDT (Assessed by two sets of venograms in PCDT arm, one baseline venogram of the proximal veins (popliteal vein through infrarenal IVC) obtained after initial catheter insertion into the venous system before PCDT; and one the final venogram of the proximal veins obtained after PCDT and any adjunctive procedures, before sheath removal. Marder score will be used to quantify clot burden. Marder score range 0-24, with 0 representing no thrombus and 24 representing complete thrombosis). The degree of thrombus elimination (% change in pre-PCDT and post-PCDT Marder score) will be calculated.
Full Information
NCT ID
NCT04411316
First Posted
May 7, 2020
Last Updated
September 1, 2021
Sponsor
University of Toledo Health Science Campus
1. Study Identification
Unique Protocol Identification Number
NCT04411316
Brief Title
Catheter-directed Thrombolysis Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis
Official Title
Pharmacomechanical Catheter-directed Thrombolysis (PCDT) Plus Anticoagulation Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis:
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Zero Patients met criteria
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
December 19, 2022 (Anticipated)
Study Completion Date
December 19, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toledo Health Science Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
Post-thrombotic syndrome (PTS) is a complication that can develop after deep vein thrombosis (DVT) of the lower extremities. PTS can occur at various times after the initial episode, but usually manifests within two years of initial DVT onset. Early and more complete thrombus clearance is believed by many to relieve venous outflow obstruction, preserve valvular function and reduce venous hypertension. Two previously published randomized controlled trials, the CAVENT trial and the ATTRACT trial, were larger and designed to investigate the efficacy of CDT. However, both of these trials included patients with iliofemoral as well as femoro-popliteal deep vein thrombosis. Our study will be limited to patients with iliofemoral deep vein thrombosis to assess whether Pharmacomechanical catheter-directed thrombolysis (PCDT) therapy utilizing AngioJet and tPA can safely and effectively reduce post thrombotic syndrome after 24 months.
Detailed Description
Patients with Iliofemoral DVT are theoretically at the highest risk for development of PRS given involvement of the major drainage pathway of both superficial femoral and deep femoral veins. This would not only affect the primary venous drainage, but would also compromise the ability to develop efficient collateral pathways. This creates higher chances of developing post-thrombotic syndrome (PTS). The proposed trial would utilize Angiojet thrombectomy followed by catheter directed thrombolysis and Anticoagulation compared to Anticoagulation alone. To assess whether Pharmacomechanical catheter-directed thrombolysis (PCDT) therapy utilizing AngioJet and tPA for the treatment of iliofemoral deep venous thrombosis can safely and effectively reduce post thrombotic syndrome after 24 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Venous Thrombosis, Post Thrombotic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacomechanical thrombolysis plus anticoagulation
Arm Type
Experimental
Arm Description
This group of patients will receive Pharmacomechanical catheter-directed thrombolysis (PCDT) plus Anticoagulation.
PCDT will be AngioJet along with alteplase. Anticoagulation will be heparin only
Arm Title
Anticoagulation
Arm Type
Active Comparator
Arm Description
This group of patients will receive standard anticoagulation only. Anticoagulation will be Heparin only
Intervention Type
Combination Product
Intervention Name(s)
Catheter directed thrombolysis plus anticoagulation
Other Intervention Name(s)
Pharmacomechanical thrombolysis
Intervention Description
Patients will be randomized to pharmacomechanical catheter directed thrombolysis plus anticoagulation.
PCDT will be AngioJet along with alteplase.
Intervention Type
Drug
Intervention Name(s)
Anticoagulation
Intervention Description
Patients will receive anticoagulation alone. Anticoagulation will be heparin only.
Primary Outcome Measure Information:
Title
Post-thrombotic syndrome at any time between 6-month and 24-month.
Description
Occurrence of post-thrombotic syndrome at any time between 6-month and 24-month after procedure by Villata score (Villata score >5 or more), or if patient underwent an unplanned endovascular procedure to treat venous symptoms.
The variables in villata scores are pain, cramps, heaviness, parasthesia, pruritus, pretibial edema, skin induration, hyperpigmentation, pain during calf compression, venous ectasia and redness.
The Villata score ranges 0-45. Villata score <5 means no post-thrombotic syndrome. Villata score 5-9 mild post-thrombotic syndrome. Villata score 10-14 means moderate post-thrombotic syndrome. Villata score ≥15 or presence of an ulcer indicates severe post-thrombotic syndrome.
The more is the score the worse is the disease.
Time Frame
6-24 months
Secondary Outcome Measure Information:
Title
Post-thrombotic syndrome at 6 months.
Description
Occurrence of post-thrombotic syndrome at 6 months measured by Villata score (Villalta score was 5 or higher).
Time Frame
6 months
Title
Post-thrombotic syndrome at 12 months.
Description
Occurrence of post-thrombotic syndrome at 12 months measured by Villata score (Villalta score was 5 or higher).
Time Frame
12 months
Title
Post-thrombotic syndrome at 18 months.
Description
Occurrence of post-thrombotic syndrome at 18 months measured by Villata score (Villalta score was 5 or higher).
Time Frame
18 months
Title
Post-thrombotic syndrome at 24 months.
Description
Occurrence of post-thrombotic syndrome at 24 months measured by Villata score (Villalta score was 5 or higher).
Time Frame
24 months
Title
Villalta scale at 6 months
Description
The severity of the post-thrombotic syndrome to be evaluated at 6 months with the use of the Villalta scale
Time Frame
6 months
Title
Villalta scale at 12 months
Description
The severity of the post-thrombotic syndrome to be evaluated at 12 months with the use of the Villalta scale.
Time Frame
12 months
Title
Villalta scale at 18 months
Description
The severity of the post-thrombotic syndrome to be evaluated at 18 months with the use of the Villalta scale.
Time Frame
18 months
Title
Villalta scale at 24 months
Description
The severity of the post-thrombotic syndrome to be evaluated at 18 months with the use of the Villalta scale.
Time Frame
24 months
Title
Venous Clinical Severity Score at 6 months
Description
The severity of the post-thrombotic syndrome to be evaluated at 6 months with the use of the Venous Clinical Severity Score.
Time Frame
6 months
Title
Venous Clinical Severity Score at 12 months
Description
The severity of the post-thrombotic syndrome to be evaluated at 12 months with the use of the Venous Clinical Severity Score.
Time Frame
12 months
Title
Venous Clinical Severity Score at 18 months
Description
The severity of the post-thrombotic syndrome to be evaluated at 18 months with the use of the Venous Clinical Severity Score.
Time Frame
18 months
Title
Venous Clinical Severity Score at 24 months
Description
The severity of the post-thrombotic syndrome to be evaluated at 24 months with the use of the Venous Clinical Severity Score.
Time Frame
24 months
Title
Health-Related Quality of Life AT 6 months
Description
Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life
Time Frame
6 months
Title
Health-Related Quality of Life at 12 months.
Description
Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life at 12 months.
Time Frame
12 months
Title
Health-Related Quality of Life at 18 months.
Description
Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life at 18 months.
Time Frame
18 months
Title
Health-Related Quality of Life at 24 months.
Description
Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life at 24 months.
Time Frame
24 months
Title
Health-Related Quality of Life at 6 months.
Description
Health-Related Quality of Life measured by Generic Quality of Life at 6 months.
Time Frame
6 months
Title
Health-Related Quality of Life at 12 months.
Description
Health-Related Quality of Life measured by Generic Quality of Life at 12 months
Time Frame
12 months
Title
Health-Related Quality of Life at 18 months.
Description
Health-Related Quality of Life measured by Generic Quality of Life at 18 months.
Time Frame
18 months
Title
Health-Related Quality of Life at 24 months.
Description
Health-Related Quality of Life measured by Generic Quality of Life at 24 months.
Time Frame
24 months
Title
Health-Related Quality of Life at 6 months.
Description
Health-Related Quality of Life measured by Administration of QOL Measures at 6 months.
Time Frame
6 months
Title
Health-Related Quality of Life at 12 months.
Description
Health-Related Quality of Life measured by Administration of QOL Measures at 12 months.
Time Frame
12 months
Title
Health-Related Quality of Life at 18 months.
Description
Health-Related Quality of Life measured by Administration of QOL Measures at 18 months.
Time Frame
18 months
Title
Health-Related Quality of Life at 24 months.
Description
Health-Related Quality of Life measured by Administration of QOL Measures at 24 months.
Time Frame
24 months
Title
Treatment Failures that are Not PTS.
Description
Treatment Failures that are Not PTS (defined as one or more of the following during the 24 months post randomization: 1) the patient underwent an unplanned endovascular or surgical intervention for the treatment of severe symptomatic venous disease in the index leg within the first 24 months after randomization (2) the subject underwent an amputation in the index leg anytime within 24 months after randomization; or (3) the subject developed venous gangrene in the index leg within the first 24 months after randomization.
Time Frame
6-24 months
Title
Severity of presenting DVT Symptoms at 6 months
Description
Severity of presenting DVT Symptoms (Leg pain severity measured by pain scale) at 6 months
Time Frame
6 months
Title
Severity of presenting DVT Symptoms at 12 months
Description
Severity of presenting DVT Symptoms (Leg pain severity measured by pain scale) at 12 months
Time Frame
12 months
Title
Severity of presenting DVT Symptoms at 18 months
Description
Severity of presenting DVT Symptoms (Leg pain severity measured by pain scale) at 18 months
Time Frame
18 months
Title
Severity of presenting DVT Symptoms at 24 months
Description
Severity of presenting DVT Symptoms (Leg pain severity measured by pain scale) at 24 months
Time Frame
24 months
Title
Severity of presenting DVT Symptoms at 6 months
Description
Severity of presenting DVT Symptoms (Leg swelling measured by measuring calf swelling) at 6 months
Time Frame
6 months
Title
Severity of presenting DVT Symptoms at 12 months
Description
Severity of presenting DVT Symptoms (Leg swelling measured by measuring calf swelling) at 12 months
Time Frame
12 months
Title
Severity of presenting DVT Symptoms at 18 months
Description
Severity of presenting DVT Symptoms (Leg swelling measured by measuring calf swelling) at 18 months
Time Frame
18 months
Title
Severity of presenting DVT Symptoms at 24 months
Description
Severity of presenting DVT Symptoms (Leg swelling measured by measuring calf swelling) at 24 months
Time Frame
24 months
Title
Degree of Resolution of Thrombus with PCDT at 6 months.
Description
Degree of Resolution of Thrombus with PCDT (Assessed by two sets of venograms in PCDT arm, one baseline venogram of the proximal veins (popliteal vein through infrarenal IVC) obtained after initial catheter insertion into the venous system before PCDT; and one the final venogram of the proximal veins obtained after PCDT and any adjunctive procedures, before sheath removal. Marder score will be used to quantify clot burden. Marder score range 0-24, with 0 representing no thrombus and 24 representing complete thrombosis). The degree of thrombus elimination (% change in pre-PCDT and post-PCDT Marder score) will be calculated.
Time Frame
6 months
Title
Degree of Resolution of Thrombus with PCDT at 12 months.
Description
Degree of Resolution of Thrombus with PCDT (Assessed by two sets of venograms in PCDT arm, one baseline venogram of the proximal veins (popliteal vein through infrarenal IVC) obtained after initial catheter insertion into the venous system before PCDT; and one the final venogram of the proximal veins obtained after PCDT and any adjunctive procedures, before sheath removal. Marder score will be used to quantify clot burden. Marder score range 0-24, with 0 representing no thrombus and 24 representing complete thrombosis). The degree of thrombus elimination (% change in pre-PCDT and post-PCDT Marder score) will be calculated.
Time Frame
12 months
Title
Degree of Resolution of Thrombus with PCDT at 18 months.
Description
Degree of Resolution of Thrombus with PCDT (Assessed by two sets of venograms in PCDT arm, one baseline venogram of the proximal veins (popliteal vein through infrarenal IVC) obtained after initial catheter insertion into the venous system before PCDT; and one the final venogram of the proximal veins obtained after PCDT and any adjunctive procedures, before sheath removal. Marder score will be used to quantify clot burden. Marder score range 0-24, with 0 representing no thrombus and 24 representing complete thrombosis). The degree of thrombus elimination (% change in pre-PCDT and post-PCDT Marder score) will be calculated.
Time Frame
18 months
Title
Degree of Resolution of Thrombus with PCDT at 24 months.
Description
Degree of Resolution of Thrombus with PCDT (Assessed by two sets of venograms in PCDT arm, one baseline venogram of the proximal veins (popliteal vein through infrarenal IVC) obtained after initial catheter insertion into the venous system before PCDT; and one the final venogram of the proximal veins obtained after PCDT and any adjunctive procedures, before sheath removal. Marder score will be used to quantify clot burden. Marder score range 0-24, with 0 representing no thrombus and 24 representing complete thrombosis). The degree of thrombus elimination (% change in pre-PCDT and post-PCDT Marder score) will be calculated.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age>18 and younger than 75
Symptomatic, proximal deep-vein thrombosis involving the Iliofemoral vein from 12/01/2019 to 12/01/2022
Exclusion Criteria:
Age less than 18 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 popliteal and/or tibial veins; or b) for which thrombolysis is planned as part of 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 months) GI bleeding, severe liver dysfunction, bleeding diathesis.
Recent (< 3 months) 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 > 180mmHg or diastolic > 105 mmHg).
Pregnant (positive pregnancy test, women of childbearing potential must be tested).
Recently (< 2 years or chronic non-ambulatory status.
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab A Eltahawy, MD
Organizational Affiliation
University of Toledo Health Science Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19303507
Citation
Vedantham S. Valvular dysfunction and venous obstruction in the post-thrombotic syndrome. Thromb Res. 2009;123 Suppl 4:S62-5. doi: 10.1016/S0049-3848(09)70146-X.
Results Reference
background
Citation
DUTCH CAVA-trial: CAtheter Versus Anticoagulation Alone for Acute Primary (Ilio)Femoral DVT. Clinicaltrial.gov
Results Reference
background
PubMed Identifier
19224134
Citation
Ashrani AA, Heit JA. Incidence and cost burden of post-thrombotic syndrome. J Thromb Thrombolysis. 2009 Nov;28(4):465-76. doi: 10.1007/s11239-009-0309-3. Epub 2009 Feb 18.
Results Reference
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PubMed Identifier
19017588
Citation
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Citation
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URL
https://clinicaltrials.gov/ct2/show/NCT00970619
Description
DUTCH CAVA-trial: CAtheter Versus Anticoagulation Alone for Acute Primary (Ilio)Femoral DVT. (NL28394)
Learn more about this trial
Catheter-directed Thrombolysis Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis
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