ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis

UCI Specialty Area: Cardiology

Principal Investigator: Anthony Chau

Official Title: DEFIANCE: ClotTriever vs. Anticoagulation for DVT

A Study On:

Heart - Cardiovascular Circulatory

Study Description

Eligibility

1.Proximal lower extremity DVT involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination.

2.Willing and able to provide informed consent.

1.Prior venous stent in the target venous segment

2.IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins

3.IVC filter in place at the time of the planned index procedure

4.Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used

5.Life expectancy less than 1 year

6.Chronic non-ambulatory status

7.Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically-managed throughout the study period

8.Unavailability of a lower extremity venous access site

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

Please read the information below and ask questions about anything that you do not understand. A
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You are being asked to participate in a clinical research potential participant database to identify
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time. If you decide to withdraw from this database you should notify the research team
immediately.

You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

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There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.

There are no alternative procedures available. The only alternative is not to participate in this study.

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The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.

While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.

Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.

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