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

NCT05003843 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 19458
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 42

Brief 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.

Conditions

Deep Vein Thrombosis; DVT

Outcome Measures

Primary Outcomes (2)

• Composite of Major Adverse Events

  Device related death, major bleeding, new symptomatic pulmonary embolism or re-thrombosis of the target venous segment and serious device related events

  48 Hours Post-Procedure

• Change in Marder Score

  Complete or near complete (75% or greater) reduction of venous thrombus from the target venous segment as measured by Marder Score pre- to post-procedure The Marder Score ranges from 0 to 24, with higher scores being worse.

  Index Procedure

Secondary Outcomes (3)

• Composite of Major Adverse Events

  30 Days Post-Procedure

• Device Related Adverse Events

  24 Months

• Villalta Scale

  24 Months

Study Arms (1)

Single Arm

OTHER

Use of Indigo Aspiration System in patients with obstruction due to DVT

Device: Indigo Aspiration System

Interventions

Indigo Aspiration System DEVICE

Indigo Aspiration System

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (42)

Sharp Grossmont

La Mesa, California, 91942, United States

Location

Long Beach Medical Center

Long Beach, California, 90806, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Christiana Care

Newark, Delaware, 19713, United States

Location

MedStar Washington

Washington D.C., District of Columbia, 20010, United States

Location

Memorial Jacksonville

Jacksonville, Florida, 32216, United States

Location

Radiology and Imaging Specialists

Lakeland, Florida, 33805, United States

Location

Baptist of Miami

Miami, Florida, 33176, United States

Location

Mount Sinai Miami

Miami Beach, Florida, 33140, United States

Location

Sarasota Memorial

Sarasota, Florida, 34239, United States

Location

Protestant Memorial Medical Center, Inc

Belleville, Illinois, 62226, United States

Location

Northwestern Memorial

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

St. Vincent

Indianapolis, Indiana, 46260, United States

Location

Indiana University Health

Indianapolis, Indiana, 46290, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Lafayette General/Cardiovascular Institute of the South

Lafayette, Louisiana, 70503, United States

Location

LSU Hospital Shreveport

Shreveport, Louisiana, 71103, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

St. Joseph Mercy Ann Arbor Hospital

Ann Arbor, Michigan, 48197, United States

Location

McLaren Greater Lansing

East Lansing, Michigan, 48910, United States

Location

Jewish Barnes Hospital

St Louis, Missouri, 63110, United States

Location

Nebraska Methodist

Omaha, Nebraska, 68118, United States

Location

Hackensack Medical Center

Hackensack, New Jersey, 07601, United States

Location

Lovelace Heart

Albuquerque, New Mexico, 87102, United States

Location

Kaleida University at Buffalo

Buffalo, New York, 14203, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Mount Sinai NY

New York, New York, 10029, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

NYU

New York, New York, 11220, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Christ Cincinnati

Cincinnati, Ohio, 45219, United States

Location

TriHealth

Cincinnati, Ohio, 45242, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

UPenn

Philadelphia, Pennsylvania, 19104, United States

Location

MUSC

Charleston, South Carolina, 29425, United States

Location

Holston Valley Medical

Kingsport, Tennessee, 37660, United States

Location

BUMC - Dallas (Scott & White)

Dallas, Texas, 75246, United States

Location

Sentara

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: September 30, 2021
• Primary Completion: November 18, 2025
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-01

Locations

US (42)