Phase 3
N=692
Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
Deep Vein Thrombosis · Venous Thrombosis · Postphlebitic Syndrome · Venous Thromboembolism · Post Thrombotic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00790335 ↗Enrolled (actual)
692
Serious AEs
28.2%
Results posted
Mar 2018
Primary outcome: Primary: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) — 157; 171 Participants — p=0.56
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Recombinant tissue plasminogen activator (rt-PA) (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jan 2017
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 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 Recurrent Venous Thromboembolism |
42; 30 | 0.09 |
| SECONDARY Death |
7; 8 | 0.83 |
| SECONDARY Death |
7; 8 | 0.83 |
| SECONDARY Severity of Post-thrombotic Syndrome (Villalta) |
3.43; 4.50 | 0.005 sig |
| SECONDARY Severity of Post-thrombotic Syndrome (Villalta) |
3.43; 4.50 | 0.005 sig |
| SECONDARY Severity of Post-thrombotic Syndrome (Villalta) |
3.43; 4.50 | 0.005 sig |
| 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 Venous Clinical Severity Score |
1.87; 2.42 | 0.03 sig |
| SECONDARY Venous Clinical Severity Score |
1.87; 2.42 | 0.03 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 Pain Severity |
-2.17; -1.83 | 0.03 sig |
| SECONDARY Change in Leg Circumference |
-0.74; -0.28 | 0.05 |
| SECONDARY Change in Leg Circumference |
-0.74; -0.28 | 0.05 |
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.
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). 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.