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

Launched by PENUMBRA INC. · Aug 4, 2021

Keywords

ClinConnect Summary

The BOLT clinical trial is studying the use of a device called the Indigo® Aspiration System to treat patients with a condition known as Deep Vein Thrombosis (DVT). DVT occurs when a blood clot forms in the deep veins of the legs, which can lead to serious complications. The trial aims to find out if this device is safe and effective for patients who have a clot in their leg veins and are eligible for treatment.

To participate in the study, individuals must be at least 18 years old and have a specific type of DVT that involves certain veins in the leg. Participants should have experienced symptoms for 14 days or less and must be able to provide informed consent. However, certain conditions, like being pregnant or having specific blood disorders, may exclude someone from joining. If eligible, participants can expect to undergo a procedure using the Indigo device, and they will be closely monitored for safety and effectiveness throughout the trial. This study is currently recruiting participants, and it presents an opportunity to contribute to medical research that may help improve treatment for DVT in the future.

Gender

ALL

Eligibility 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