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

  • End date
    Sep 18, 2025
  • participants needed
  • sponsor
    Penumbra Inc.
Updated on 18 June 2022
deep vein thrombosis
blood clot
deep venous thrombosis of lower extremity


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.

Condition Deep Vein Thrombosis, DVT
Treatment Indigo Aspiration System
Clinical Study IdentifierNCT05003843
SponsorPenumbra Inc.
Last Modified on18 June 2022


Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

Contraindication to systemic or therapeutic doses of anticoagulants
Contraindication to iodinated contrast venography that cannot be adequately premedicated
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 mmHg and/or patient on IV vasoactive medication to support blood pressure), or intermediate high-risk PE, as defined by the European Society Guideline on management 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 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, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Pre-existing caval or iliofemoral device (e.g. IVC filter, stent obstruction, etc.)
Congenital anatomic anomalies of the IVC or iliac veins
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