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

Running, not enrolling · Not applicable

Conditions studied: Deep Vein Thrombosis, DVT

In brief

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.

Key facts

Study ID

NCT05003843

Run by

Penumbra Inc.

People needed

229

Starts

2021-09-30

Expected to finish

2028-01-01

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Sharp Grossmont — La Mesa, California, United States
• Long Beach Medical Center — Long Beach, California, United States
• UCLA — Los Angeles, California, United States
• Christiana Care — Newark, Delaware, United States
• MedStar Washington — Washington D.C., District of Columbia, United States
• Memorial Jacksonville — Jacksonville, Florida, United States
• Radiology and Imaging Specialists — Lakeland, Florida, United States
• Baptist of Miami — Miami, Florida, United States
• Mount Sinai Miami — Miami Beach, Florida, United States
• Sarasota Memorial — Sarasota, Florida, United States
• Protestant Memorial Medical Center, Inc — Belleville, Illinois, United States
• Northwestern Memorial — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• St. Vincent — Indianapolis, Indiana, United States
• Indiana University Health — Indianapolis, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• Lafayette General/Cardiovascular Institute of the South — Lafayette, Louisiana, United States
• LSU Hospital Shreveport — Shreveport, Louisiana, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• St. Joseph Mercy Ann Arbor Hospital — Ann Arbor, Michigan, United States
• McLaren Greater Lansing — East Lansing, Michigan, United States
• Jewish Barnes Hospital — St Louis, Missouri, United States
• Nebraska Methodist — Omaha, Nebraska, United States
• Hackensack Medical Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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