At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- ClotTriever System (device), Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. (drug)
- How long the study runs
- Study runs about 66 months (dates as stated)
- About the drug or intervention
- ClotTriever System — device: Mechanical thrombectomy · Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. — drug: Anticoagulants are a group of medications that decrease your blood's ability to clot.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 300
- Started
- 2023-01-06
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for venous thromboembolism
- • NA - 300 participants
- • This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with venous thromboembolism
Where?
- • London - GSST London/St Thomas
- • London - Imperial College
- • Newcastle upon Tyne - Freeman Hospital Newcastle upon Tyne
- • Oxford - Oxford - John Radcliffe
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit.
More detail
The study will compare the clinical outcomes of patients treated with an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of symptomatic unilateral iliofemoral DVT. Approximately 300 subjects will be enrolled and randomized. All subjects who sign informed consent and who meet all of the inclusion criteria and none of the exclusion criteria will be randomized (1:1, ClotTriever Intervention Arm or Conservative Medical Management Arm).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Inclusion Criteria
- ✓Age ≥ 18 years
- ✓Proximal lower extremity unilateral DVT involving at least the common femoral, external iliac, or common iliac...
- ✓Symptom onset within 12 weeks of enrollment in the study
- ✓Significant symptoms, as defined by a Villalta score \> 9
See the full criteria
Where Is This Study? (4 UK sites)
GSST London/St Thomas
London, United Kingdom
Imperial College
London, United Kingdom
Freeman Hospital Newcastle upon Tyne
Newcastle upon Tyne, United Kingdom
Oxford - John Radcliffe
Oxford, United Kingdom
How to Get in Touch
Mark Sung
Sponsor contactCONTACT
Sara Willis
Sponsor contactCONTACT
