Phase 3
Completed N=692
Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
Source: ClinicalTrials.gov NCT00790335 ↗Enrolled (actual)
692
Serious AEs
28.2%
Results posted
Mar 2018
Primary outcomePrimary: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) — 157; 171 Participants — p=0.56
◆ Published Evidence
Established
86citations · ~14 / year
Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis.
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.
Linked Publications (5)
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Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis.
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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.
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Time-Restricted Salutary Effects of Blood Flow Restoration on Venous Thrombosis and Vein Wall Injury in Mouse and Human Subjects.
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Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial.
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Angioplasty or stenting for deep venous thrombosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) |
157; 171 | 0.56 |
| SECONDARY Major Non-post-thrombotic Syndrome Treatment Failure |
4; 7 | 0.38 |
| SECONDARY Any Treatment Failure |
158; 176 | 0.39 |
| SECONDARY Moderate-to-severe Post-thrombotic Syndrome |
60; 84 | 0.04 sig |
| SECONDARY Major Bleeding |
19; 13 | 0.23 |
| SECONDARY Any (Minor + Major) Bleeding |
15; 6 | 0.03 sig |
| SECONDARY Any (Major + Minor) Bleeding |
46; 38 | 0.25 |
| SECONDARY Recurrent Venous Thromboembolism |
42; 30 | 0.09 |
| SECONDARY Death |
7; 8 | 0.83 |
| SECONDARY Severity of Post-thrombotic Syndrome (Villalta) |
3.43; 4.50 | 0.005 sig |
| SECONDARY Venous Clinical Severity Score |
1.87; 2.42 | 0.03 sig |
| SECONDARY Change in General Quality of Life - Physical |
11.18; 10.06 | 0.37 |
| SECONDARY Change in General Quality of Life - Mental |
2.70; 2.70 | 0.99 |
| SECONDARY Change in Venous Disease-specific Quality of Life |
27.67; 23.47 | 0.08 |
| SECONDARY Change in Leg Pain Severity |
-2.17; -1.83 | 0.03 sig |
| SECONDARY Change in Leg Circumference |
-0.74; -0.28 | 0.05 |
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 1.6 before warfarin was started, or platelets 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).
Data sourced from ClinicalTrials.gov (NCT00790335) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.