ClotTriever Outcomes (CLOUT) Registry (CLOUT)
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ClinicalTrials.gov Identifier: NCT03575364 |
Recruitment Status :
Active, not recruiting
First Posted : July 2, 2018
Last Update Posted : March 22, 2024
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Condition or disease | Intervention/treatment |
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Deep Vein Thrombosis Leg DVT Chronic DVT of Lower Extremity Acute DVT of Lower Extremity | Device: ClotTriever |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 2 Years |
Official Title: | ClotTriever Outcomes (CLOUT) Registry |
Actual Study Start Date : | September 1, 2018 |
Actual Primary Completion Date : | March 25, 2022 |
Estimated Study Completion Date : | March 31, 2024 |
Group/Cohort | Intervention/treatment |
---|---|
Primary Analytic
Patients with unilateral acute or subacute DVT of less than 6 weeks' duration.
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Device: ClotTriever
Thrombectomy |
Registry
Patients with proximal lower extremity DVT.
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Device: ClotTriever
Thrombectomy |
- Composite of Major Adverse Events (MAEs) [ Time Frame: 30 days ]All-cause mortality, major bleeding, symptomatic PE, or rethrombosis of target venous segment
- Technical Success [ Time Frame: Index procedure ]Complete or near complete (75% or greater) removal of venous thrombus from the target venous segment
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575364
Responsible Party: | Inari Medical |
ClinicalTrials.gov Identifier: | NCT03575364 |
Other Study ID Numbers: |
18-001 |
First Posted: | July 2, 2018 Key Record Dates |
Last Update Posted: | March 22, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
ClotTriever Thrombectomy |
Thrombosis Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |