BOLT: A Prospective Multicenter Study of Patients with Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo Aspiration System.
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Deep Vein Thrombosis (dvt)
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Age: Between 18 Year(s) - 100 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- Unilateral lower extremity Deep Vein Thrombosis (DVT) occlusion involving iliac and/or common femoral veins or femoral in combination with iliac veins, including patients with extension of clot into the contralateral common iliac vein
- Acute thrombotic or thromboembolic occlusion with symptom duration of 14 days or less at presentation
- Informed consent is obtained
You may not be eligible for this study if the following are true:
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- Contraindication to systemic or therapeutic doses of anticoagulants
- Contraindication to iodinated contrast venography that cannot be adequately premedicated
- Complete infrarenal inferior vena cava (IVC) occlusion
- In the index leg: prior DVT
- Prior stent in target venous segment
- Treatment of index DVT with thrombolytics within 14 days prior to index procedure
- Pulmonary embolism (PE) defined as either high (systolic blood pressure < 90 mmHg and/or patient on IV vasoactive medication to support blood pressure), or intermediate high-risk PE. Low risk PE and/or intermediate low risk PE can be enrolled.
- Known coagulation disorders both acquired (e.g., Heparin Induced Thrombocytopenia, etc.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable state
- Pregnant patients
- Life expectancy <1 year due to comorbidities
- Active cancer: metastatic, progressive, or treated with chemotherapy or radiation therapy in the last 6 months, with the exception of patients with non-melanoma primary skin cancers
- Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
- Other medical, behavioral, or psychological conditions that precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements
- Congenital anatomic anomalies of the inferior vena cava (IVC) or iliac veins
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.