Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsNA

DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis

Sponsor: Inari Medical

NCT ID: NCT05701917

View on ClinicalTrials.gov ↗

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).

Venous ThromboembolismDeep Venous ThrombosisPost-Thrombotic Syndrome

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria * Age ≥ 18 years * Proximal lower extremity unilateral DVT involving at least the common femoral, external iliac, or common iliac veins, alone or in combination * Symptom onset within 12 weeks of enrollment in the study * Significant symptoms, as defined by a Villalta score \> 9 * Willing and able to provide informed consent Exclusion Criteria * Bilateral iliofemoral DVT * Prior venous stent in the target venous segment * IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins * IVC filter in place at the time of enrollment * Limb-threatening circulatory compromise (e.g., phlegmasia) * Clot in transit including IVC thrombus presenting as extension of \>2cm into the IVC from the CIV * Symptomatic PE with right heart strain where the physician judges that a DVT intervention is inappropriate at this time. * Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement * Severe allergy, hypersensitivity to, or thrombocytopenia from heparin * Severe allergy to iodinated contrast agents that cannot be mitigated * Hemoglobin \< 8.0 g/dL, INR \> 1.7 before warfarin was started, or platelets \< 50,000/µl which cannot be corrected prior to enrollment * Severe renal impairment (estimated GFR \< 30 ml/min) in patients who are not yet on dialysis * Inability to provide therapeutic anticoagulation per Investigator discretion * Uncontrolled severe hypertension on repeated readings (systolic \> 180mmHg or diastolic \> 105mmHg) * Recently (\< 30 days) had DVT interventional procedure * Subject is participating in another study that may interfere with this study * Life expectancy \< 6 months or chronic non-ambulatory status * Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period * Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (e.g., contraindication to use of ClotTriever per local approved labeling, compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments) * Subject has previously completed or withdrawn from this study * Patient unwilling or unable to conduct the follow up visits per protocol

Where Is This Study? (4 UK sites)

GSST London/St Thomas

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.RandD@nhs.net

gstt.RandD@nhs.net---

Imperial College

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

Freeman Hospital Newcastle upon Tyne

Newcastle upon Tyne, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

nuth.genericqueries@nhs.net0191 282 4926

Oxford - John Radcliffe

Oxford, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Support Team

research@oxfordhealth.nhs.uk01865 902401

How to Get in Touch

Mark Sung

Sponsor contact

CONTACT

949-466-9458 mark.sung@stryker.com

Sara Willis

Sponsor contact

CONTACT

sara.willis@stryker.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09