BOLT
Brief description of study
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.
Detailed description of study
The participants will have a mechanical aspiration thrombectomy procedure that removes the blood clot from their body using the Indigo Aspiration System (study device).
Approximately 290 participants from up to 50 hospitals in the United States will be participating in this study. This study will last approximately two years.
Before the participants are treated for their DVT, the hospital staff will perform routine tests and procedures to evaluate the severity of the DVT and the participants’ general state of health. Imaging tests will be done to identify and locate the blood clots. Additionally, the doctor will evaluate the state of the DVT and how it affects the participants’ quality of life before treatment.
Post procedure, participants will be monitored according to the study doctor’s routine care. Additional examinations, questionnaires, testing, and imaging may be done.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: 99 years or below
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Gender: All
Inclusion
Unilateral lower extremity DVT occlusion involving iliac and/or common femoral 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
Frontline treatment with Indigo Aspiration System in the target venous segment per Investigator decision
Exclusion
Prior stent in target venous segment
Treatment of index DVT with thrombolytics within 14 days prior to index procedure
Pulmonary embolism (PE) or intermediate high-risk PE.
Known coagulation disorders both acquired or genetic
Pregnant patients
Life expectancy <1 year due to comorbidities
Certain types of active cancer
Current participation in other clinical research studies
