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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05701917
Other study ID # 22-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 6, 2023
Est. completion date October 31, 2025

Study information

Verified date May 2024
Source Inari Medical
Contact Christine Wills
Phone 6027992920
Email christine.wills@inarimedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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. Up to 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date October 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
ClotTriever System
Mechanical thrombectomy
Drug:
Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Anticoagulants are a group of medications that decrease your blood's ability to clot.

Locations

Country Name City State
Finland Helsinki University Hospital Helsinki
Germany Klinikum Hochsauerland GmbH Arnsberg Nordrhein-Westfalen
Germany Universitätsklinikum Augsburg Augsburg
Germany Charité - Universitätsmedizin Berlin Berlin
Germany MVZ CCB Frankfurt und Main-Taunus GbR Frankfurt Hessen
Germany Universität Leipzig Leipzig Sachsen
Germany Universitätsklinikum Tübingen Tübingen Baden-Würtemberg
Switzerland Inselspital, Universitätsspital Bern Bern
United Kingdom GSST London/St Thomas London
United Kingdom Oxford - John Radcliffe Oxford
United States Mission Health Asheville North Carolina
United States McLaren Healthcare Bay City Michigan
United States Northwell Health Bay Shore New York
United States Manatee Memorial Hospital Bradenton Florida
United States NYP-Brooklyn Methodist Brooklyn New York
United States SUNY, The University at Buffalo Buffalo New York
United States Mercy Health - The Heart Institute Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States University of Missouri Columbia Missouri
United States Clements University Hospital (UTSW) Dallas Texas
United States University Of Colorado Denver Colorado
United States St. Elizabeth Edgewood Edgewood Kentucky
United States Allegheny St. Vincent Hospital Erie Pennsylvania
United States Prisma Health Upstate Greenville South Carolina
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States Lakeland Vascular Institute Lakeland Florida
United States HCA Florida Largo Hospital Largo Florida
United States Aurora St. Luke's Medical Center Milwaukee Wisconsin
United States Community Healthcare System Munster Indiana
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale University New Haven Connecticut
United States Columbia University Irving Medical Center New York New York
United States NYU Langone Medical Center New York New York
United States Sentara Norfolk General Hospital Norfolk Virginia
United States UCI Medical Center Orange California
United States Vascular and Interventional Specialists of Orange County Orange California
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Allegheny General Health Research Network Pittsburgh Pennsylvania
United States St. Louis University Saint Louis Missouri
United States Sarasota Memorial Hospital Sarasota Florida
United States Memorial Health University Medical Center Savannah Georgia
United States Honor Health Scottsdale Arizona
United States Spartanburg Medical Center Spartanburg South Carolina
United States Providence Sacred Heart Med Center Spokane Washington
United States Holy Name Medical Center Teaneck New Jersey
United States Saint Francis Hospital Tulsa Oklahoma
United States MedStar Health Research Institution Washington District of Columbia
United States Lexington Medical Center West Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Inari Medical

Countries where clinical trial is conducted

United States,  Finland,  Germany,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: Occurrence of treatment failure or therapy escalation
Assessment of PTS severity, as defined by the Villalta scale
180 Days (+-14 Days)
Secondary Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: Vessel compressibility assessed by duplex ultrasound
Pain as assessed by the NPRS
An improvement of edema as assessed by leg calf circumference measurements
10 Days (+- 3 Days)
Secondary Assessment of PTS Severity: a. Assessment of PTS severity, as defined by the Villalta scale 180 Days (+-14 Days)
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