BOLT: A Prospective, Multicenter Study of Patients With Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System
The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment.
• Unilateral lower extremity DVT occlusion involving iliac and/or common femoral veins with up to 2 cm extension in the inferior vena cava (IVC) or femoral in combination with iliac veins, including patients with extension of clot into the contralateral common iliac vein Note: Patients with non-iliofemoral DVT in the contralateral limb, who do not require endovascular treatment, may be enrolled
• Acute thrombotic or thromboembolic occlusion with symptom duration of 14 days or less at presentation
• Frontline treatment with Indigo Aspiration System in the target venous segment per Investigator decision
• Patient is ≥18 years of age
• Informed consent is obtained per Institutional Review Board requirements