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Using the Indigo Aspiration System for treating Deep Vein Thrombosis

BOLT: A Prospective, Multicenter Study of Patients With Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System

Not applicable Interventional Penumbra Inc. · NCT05003843

This study is testing a new device called the Indigo Aspiration System to see if it can safely and effectively treat deep vein thrombosis in patients with blocked veins in their legs.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment290 (estimated)
Ages18 Years and up
SexAll
SponsorPenumbra Inc. Industry-sponsored
Locations41 sites (La Mesa, California and 40 other locations)
Trial IDNCT05003843 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of the Indigo Aspiration System for performing mechanical thrombectomy in patients suffering from deep vein thrombosis (DVT). It focuses on individuals with unilateral lower extremity DVT occlusion, particularly in the iliac and common femoral veins. Eligible patients will receive treatment with the Indigo Aspiration System, and outcomes will be assessed to determine the system's efficacy in relieving venous obstruction. The study is designed to provide insights into a new approach for managing DVT.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with acute unilateral lower extremity DVT occlusion involving specific veins.

Not a fit: Patients with contraindications to anticoagulants or iodinated contrast venography, or those with complete infrarenal IVC occlusion, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with deep vein thrombosis by providing a safer and more effective method for clot removal.

How similar studies have performed: While this approach is relatively novel, similar mechanical thrombectomy techniques have shown promise in other studies, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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

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
* Primary brain, metastatic cancer or marrow malignancies
* 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 malpositioned stent(s) that obstructs the ostium of the index iliac vein and contacts the vena cava wall as demonstrated by venography prior to the index procedure
* Congenital anatomic anomalies of the IVC or iliac veins

Where this trial is running

La Mesa, California and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Deep Vein ThrombosisDVT
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.