BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
NCT ID: NCT05003843
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
229 participants
INTERVENTIONAL
2021-09-30
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Use of Indigo Aspiration System in patients with obstruction due to DVT
Indigo Aspiration System
Indigo Aspiration System
Interventions
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Indigo Aspiration System
Indigo Aspiration System
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Penumbra Inc.
INDUSTRY
Responsible Party
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Locations
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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
Lovelace Heart
Albuquerque, New Mexico, United States
Kaleida University at Buffalo
Buffalo, New York, United States
Weill Cornell Medicine
New York, New York, United States
Mount Sinai NY
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
NYU
New York, New York, United States
Stony Brook University
Stony Brook, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
Christ Cincinnati
Cincinnati, Ohio, United States
TriHealth
Cincinnati, Ohio, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
UPenn
Philadelphia, Pennsylvania, United States
MUSC
Charleston, South Carolina, United States
Holston Valley Medical
Kingsport, Tennessee, United States
BUMC - Dallas (Scott & White)
Dallas, Texas, United States
Sentara
Norfolk, Virginia, United States
Countries
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Other Identifiers
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19458
Identifier Type: -
Identifier Source: org_study_id