Clinical Trial TitleBOLT: A Prospective, Multicenter Study of Patients with Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo Aspiration System
National Clinical Trial Number:NCT05003843
Clinical Trial Protocol Description:
Patients presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment using the Indigo Aspiration system for percutaneous mechanical thrombectomy. All subjects are followed for approximately 2 years. Safety and efficacy measured by monitoring major events and reduction of venous thrombosis measured by Marder Score pre- to post-procedure.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Present with unilateral lower extremity DVT occlusion involving iliac and/or common femoral in combination with iliac veins, including patients with extension of clot into the contralateral common iliac vein.
- Have acute thrombotic or thromboembolic occlusion symptoms for at least 14 days.
- Have Frontline treatment with Indigo Aspiration System in the target venous segment.
You will be excluded from the study if any of the following criteria apply to you:
- Have contraindication to systemic or therapeutic doses of anticoagulants.
- Have presence of intrarenal IVC occlusion or prior DVT, Presence of Pulmonary Embolism defined as either high or intermediate high-risk PE, and known coagulation disorders.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.