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Clinical Trials in the USA / NCT05003843
Active, not recruiting Not applicable

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

NCT05003843 · tracked via the Priya Life Science USA tracker
Sponsor
Penumbra Inc.
Phase
Not applicable
Started
2021-09-30
Last updated
2026-09-08

Condition(s) studied

Deep Vein ThrombosisDVT

Investigational drug(s) / intervention(s)

Indigo Aspiration System

Indigo Aspiration System: Indigo Aspiration System

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
Sharp Grossmont La Mesa California
Long Beach Medical Center Long Beach California
UCLA Los Angeles California
Christiana Care Newark Delaware
MedStar Washington Washington D.C. District of Columbia
Memorial Jacksonville Jacksonville Florida
Radiology and Imaging Specialists Lakeland Florida
Baptist of Miami Miami Florida
Mount Sinai Miami Miami Beach Florida
Sarasota Memorial Sarasota Florida
Protestant Memorial Medical Center, Inc Belleville Illinois
Northwestern Memorial Chicago Illinois
Rush University Medical Center Chicago Illinois
St. Vincent Indianapolis Indiana
Indiana University Health Indianapolis Indiana
University of Kentucky Lexington Kentucky
Lafayette General/Cardiovascular Institute of the South Lafayette Louisiana
LSU Hospital Shreveport Shreveport Louisiana
UMass Memorial Medical Center Worcester Massachusetts
University of Michigan Ann Arbor Michigan
St. Joseph Mercy Ann Arbor Hospital Ann Arbor Michigan
McLaren Greater Lansing East Lansing Michigan
Jewish Barnes Hospital St Louis Missouri
Nebraska Methodist Omaha Nebraska
Hackensack Medical Center Hackensack New Jersey
Lovelace Heart Albuquerque New Mexico
Kaleida University at Buffalo Buffalo New York
Weill Cornell Medicine New York New York
Mount Sinai NY New York New York
Lenox Hill Hospital New York New York
NYU New York New York
Stony Brook University Stony Brook New York
Duke University Medical Center Durham North Carolina
NC Heart and Vascular Research Raleigh North Carolina
Christ Cincinnati Cincinnati Ohio
TriHealth Cincinnati Ohio
Lancaster General Hospital Lancaster Pennsylvania
UPenn Philadelphia Pennsylvania
MUSC Charleston South Carolina
Holston Valley Medical Kingsport Tennessee

+ 2 more sites — see the full list on the official registry below.

More Penumbra Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05003843 on ClinicalTrials.gov ↗ ← All trials in the USA