BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis

Inclusion Criteria:

• Unilateral lower extremity DVT occlusion involving iliac and/or common femoral veinswith up to 2 cm extension in the inferior vena cava (IVC) or femoral in combinationwith iliac veins, including patients with extension of clot into the contralateralcommon iliac vein

• Acute thrombotic or thromboembolic occlusion with symptom duration of 14 days orless at presentation

• Frontline treatment with Indigo Aspiration System in the target venous segment perInvestigator decision

• Patient is ≥18 years of age

• Informed consent is obtained per Institutional Review Board requirements

Exclusion Criteria:

• Contraindication to systemic or therapeutic doses of anticoagulants

• Contraindication to iodinated contrast venography that cannot be adequatelypremedicated

• Complete infrarenal 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 mmHgand/or patient on IV vasoactive medication to support blood pressure), orintermediate high-risk PE, as defined by the European Society Guideline onmanagement of 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 hypercoagulablestate

• Pregnant patients

• Life expectancy <1 year due to comorbidities

• Active cancer: metastatic, progressive, or treated with chemotherapy or radiationtherapy in the last 6 months, with the exception of patients with non-melanomaprimary skin cancers

• Current participation in another investigational drug or device study that mayconfound the results of this study. Studies requiring extended follow-up forproducts that were investigational but have since become commercially available arenot considered investigational studies.

• Other medical, behavioral, or psychological conditions that, in the opinion of theInvestigator, precludes the patient from appropriate consent, could limit thepatient's ability to participate in the study, including compliance with follow-uprequirements, or that could impact the scientific integrity of the study

• Pre-existing malpositioned stent(s) that obstructs the ostium of the index iliacvein and contacts the vena cava wall as demonstrated by venography prior to theindex procedure

• Congenital anatomic anomalies of the IVC or iliac veins