Acute DVT of Lower Extremity, Chronic DVT of Lower Extremity, Deep Vein Thrombosis Leg, DVT
Conditions
Keywords
ClotTriever, Thrombectomy
Brief summary
Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.
Detailed description
The CLOUT Registry is a prospective, multi-center, observational registry of subjects with proximal lower extremity DVT treated with the ClotTriever Thrombectomy System. The Registry will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through 2 years of follow-up.
Interventions
DEVICEClotTriever
Thrombectomy
Sponsors
Inari Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Proximal lower extremity DVT involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination. * Willing and able to provide informed consent.
Exclusion criteria
* 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 the planned index procedure * Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used * Life expectancy less than 1 year * Chronic non-ambulatory status * Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically-managed throughout the study period * Unavailability of a lower extremity venous access site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint: Proportion Participants With Major Adverse Events | 30 days | The primary safety endpoint is the proportion of participants with Major Adverse Events (MAE). MAEs are defined as a composite endpoint triggered when any of four categories of events occurred through 30 days after the index procedure, as observed in the Primary Safety Cohort (the composite endpoints were not observed for the Full Analysis Population: * All-cause mortality * Major bleeding * New symptomatic pulmonary embolism (PE) documented by computed tomography pulmonary angiography (CTPA) * Rethrombosis of a target vessel segment (TVS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus | Index Procedure (approximately 0.5 hours on day 0) | Complete or near complete (≥75%) removal of venous thrombus from the TVS, as determined by the percent reduction in the Marder score for those segments. When more than one venous segment is treated, the change in Marder score is calculated as the total score for the treated segments prior to intervention with the study device (baseline score) minus the total score after treatment with the study device but before treatment with any adjunctive devices or pharmacologic agents (post-treatment score), divided by the baseline score. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint (Full Analysis Population): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus | Index Procedure (approximately 0.5 hours on day 0) | Complete or near complete (≥75%) removal of venous thrombus from the TVS, as determined by the percent reduction in the Marder score for those segments. When more than one venous segment is treated, the change in Marder score is calculated as the total score for the treated segments prior to intervention with the study device (baseline score) minus the total score after treatment with the study device but before treatment with any adjunctive devices or pharmacologic agents (post-treatment score), divided by the baseline score. |
Countries
United States
Participant flow
Recruitment details
All patients presenting to the hospital/emergency department with proximal lower extremity deep vein thrombosis (DVT) and meeting all eligibility requirements for enrollment in the CLOUT study.
Pre-assignment details
The first 91 subjects with unilateral acute or subacute DVT of less than or equal to 6 weeks' duration without recent (≤ 3 month) history of venous intervention were enrolled in the Primary Analysis Population. Once the Primary Analysis Population was fully accrued, subjects meeting the study criteria continued to be enrolled and were evaluated as part of the Full Analysis Population.
Participants by arm
| Arm | Count |
|---|---|
| Full Analysis Population The Full Analysis Population consists of 499 subjects with proximal lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination. | 499 |
| Total | 499 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 45 |
| Overall Study | Hospital Administration decision, Research department closed | 6 |
| Overall Study | Lost to Follow-up | 114 |
| Overall Study | Patient is lost to follow up | 1 |
| Overall Study | Patient moved out of the state | 1 |
| Overall Study | Patient no longer has insurance, will not return to clinic. | 1 |
| Overall Study | Patient was unable to get to the clinic due to health problems and transportation difficulties | 1 |
| Overall Study | Physician Decision | 11 |
| Overall Study | Subject Refused Follow-up | 13 |
| Overall Study | Withdrawal by Subject | 21 |
Baseline characteristics
| Characteristic | Full Analysis Population |
|---|---|
| Age, Continuous | 61.85 years |
| BMI (kg/m^2) | 30.203 kg/m^2 |
| Height (cm) | 170.20 cm |
| Race/Ethnicity, Customized American Indian or Alaska | 4 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 101 Participants |
| Race/Ethnicity, Customized More than one race | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 4 Participants |
| Race/Ethnicity, Customized Unknown or Missing | 11 Participants |
| Race/Ethnicity, Customized White | 374 Participants |
| Sex: Female, Male Female | 252 Participants |
| Sex: Female, Male Male | 247 Participants |
| Weight (kg) | 88.50 kg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 45 / 330 |
| other Total, other adverse events | 76 / 499 |
| serious Total, serious adverse events | 120 / 499 |
Outcome results
Primary
Primary Safety Endpoint: Proportion Participants With Major Adverse Events
The primary safety endpoint is the proportion of participants with Major Adverse Events (MAE). MAEs are defined as a composite endpoint triggered when any of four categories of events occurred through 30 days after the index procedure, as observed in the Primary Safety Cohort (the composite endpoints were not observed for the Full Analysis Population: * All-cause mortality * Major bleeding * New symptomatic pulmonary embolism (PE) documented by computed tomography pulmonary angiography (CTPA) * Rethrombosis of a target vessel segment (TVS)
Time frame: 30 days
Population: The Primary Analysis Population is a subset of the Full Analysis Population, comprising the first 91 subjects with unilateral acute or subacute DVT of less than or equal to 6 weeks duration without recent (≤ 3 month) history of venous intervention.~The Primary Safety Cohort are the 76 subjects in the Primary Analysis Population who had evaluable data for the primary safety endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Safety Cohort | Primary Safety Endpoint: Proportion Participants With Major Adverse Events | 15 Participants |
Secondary
Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus
Complete or near complete (≥75%) removal of venous thrombus from the TVS, as determined by the percent reduction in the Marder score for those segments. When more than one venous segment is treated, the change in Marder score is calculated as the total score for the treated segments prior to intervention with the study device (baseline score) minus the total score after treatment with the study device but before treatment with any adjunctive devices or pharmacologic agents (post-treatment score), divided by the baseline score.
Time frame: Index Procedure (approximately 0.5 hours on day 0)
Population: The Primary Analysis Population is a subset of the Full Analysis Population is the first 91 subjects with unilateral acute or subacute DVT of less than or equal to 6 weeks duration without recent (≤ 3 months) history of venous intervention.~The Primary Effectiveness Cohort are the 89 subjects in the Primary Analysis Population with core laboratory-documented intraluminal thrombus at pre- and post- index procedure who have at least one target venous segment (TVS) treated with the study device.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Safety Cohort | Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus | 68 Participants |
Other Pre-specified
Primary Effectiveness Endpoint (Full Analysis Population): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus
Complete or near complete (≥75%) removal of venous thrombus from the TVS, as determined by the percent reduction in the Marder score for those segments. When more than one venous segment is treated, the change in Marder score is calculated as the total score for the treated segments prior to intervention with the study device (baseline score) minus the total score after treatment with the study device but before treatment with any adjunctive devices or pharmacologic agents (post-treatment score), divided by the baseline score.
Time frame: Index Procedure (approximately 0.5 hours on day 0)
Population: The Full Analysis Population consists of 499 subjects with proximal lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Safety Cohort | Primary Effectiveness Endpoint (Full Analysis Population): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus | 443 Participants |