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

Purpose

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.

Conditions

  • Deep Vein Thrombosis
  • DVT

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Single Arm 		Use of Indigo Aspiration System in patients with obstruction due to DVT
  • Device: Indigo Aspiration System
    Indigo Aspiration System

Recruiting Locations

Sharp Grossmont
La Mesa, California 91942

Christiana Care
Newark, Delaware 19713

MedStar Washington
Washington, District of Columbia 20010

Memorial Jacksonville
Jacksonville, Florida 32216

Radiology and Imaging Specialists
Lakeland, Florida 33805

Mount Sinai Miami
Miami Beach, Florida 33140

Baptist of Miami
Miami, Florida 33176

Sarasota Memorial
Sarasota, Florida 34239

Protestant Memorial Medical Center, Inc
Belleville, Illinois 62226

Northwestern Memorial
Chicago, Illinois 60611

Rush University Medical Center
Chicago, Illinois 60612

St. Vincent
Indianapolis, Indiana 46260

University of Kentucky
Lexington, Kentucky 40506

Lafayette General/Cardiovascular Institute of the South
Lafayette, Louisiana 70503

LSU Hospital Shreveport
Shreveport, Louisiana 71103

UMass Memorial Medical Center
Worcester, Massachusetts 01655

McLaren Greater Lansing
East Lansing, Michigan 48910

Jewish Barnes Hospital
Saint Louis, Missouri 63110

Nebraska Methodist
Omaha, Nebraska 68118

Hackensack Medical Center
Hackensack, New Jersey 07601

Lovelace Heart
Albuquerque, New Mexico 87102

Kaleida University at Buffalo
Buffalo, New York 14203

Weill Cornell Medicine
New York, New York 10021

Mount Sinai NY
New York, New York 10029

Lenox Hill Hospital
New York, New York 10075

NYU
New York, New York 11220

Stony Brook University
Stony Brook, New York 11794

Duke University Medical Center
Durham, North Carolina 27710

NC Heart and Vascular Research
Raleigh, North Carolina 27607

Christ Cincinnati
Cincinnati, Ohio 45219

TriHealth
Cincinnati, Ohio 45242

Lancaster General Hospital
Lancaster, Pennsylvania 17602

UPenn
Philadelphia, Pennsylvania 19104

MUSC
Charleston, South Carolina 29425

Holston Valley Medical
Kingsport, Tennessee 37660

BUMC - Dallas (Scott & White)
Dallas, Texas 75246

Sentara
Norfolk, Virginia 23507

More Details

NCT ID
NCT05003843
Status
Recruiting
Sponsor
Penumbra Inc.

Study Contact

Aisha Pascua
+1 415-601-9561
apascua@penumbrainc.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center