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Deep Vein ThrombosisNCT05003843

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

A study testing Indigo Aspiration System in people with Deep Vein Thrombosis and DVT, run by Penumbra Inc. at 42 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Deep Vein Thrombosis, DVT
What is being tested?
Indigo Aspiration System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
229 participants
Where
42 sitesUnited States
Study dates
30 Sep 2021to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • Lovelace Heart

    Albuquerque, New Mexico, 87102

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • St. Joseph Mercy Ann Arbor Hospital

    Ann Arbor, Michigan, 48197

  • Protestant Memorial Medical Center, Inc

    Belleville, Illinois, 62226

  • Kaleida University at Buffalo

    Buffalo, New York, 14203

  • MUSC

    Charleston, South Carolina, 29425

  • Northwestern Memorial

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Christ Cincinnati

    Cincinnati, Ohio, 45219

  • TriHealth

    Cincinnati, Ohio, 45242

  • BUMC - Dallas (Scott & White)

    Dallas, Texas, 75246

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • McLaren Greater Lansing

    East Lansing, Michigan, 48910

  • Hackensack Medical Center

    Hackensack, New Jersey, 07601

  • St. Vincent

    Indianapolis, Indiana, 46260

  • Indiana University Health

    Indianapolis, Indiana, 46290

  • Memorial Jacksonville

    Jacksonville, Florida, 32216

  • Holston Valley Medical

    Kingsport, Tennessee, 37660

  • Sharp Grossmont

    La Mesa, California, 91942

  • Lafayette General/Cardiovascular Institute of the South

    Lafayette, Louisiana, 70503

  • Radiology and Imaging Specialists

    Lakeland, Florida, 33805

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • University of Kentucky

    Lexington, Kentucky, 40506

  • Long Beach Medical Center

    Long Beach, California, 90806

  • UCLA

    Los Angeles, California, 90095

  • Baptist of Miami

    Miami, Florida, 33176

  • Mount Sinai Miami

    Miami Beach, Florida, 33140

  • 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

  • Christiana Care

    Newark, Delaware, 19713

  • Sentara

    Norfolk, Virginia, 23507

  • Nebraska Methodist

    Omaha, Nebraska, 68118

  • UPenn

    Philadelphia, Pennsylvania, 19104

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27607

  • Sarasota Memorial

    Sarasota, Florida, 34239

  • LSU Hospital Shreveport

    Shreveport, Louisiana, 71103

  • Jewish Barnes Hospital

    St Louis, Missouri, 63110

  • Stony Brook University

    Stony Brook, New York, 11794

  • MedStar Washington

    Washington D.C., District of Columbia, 20010

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: BOLT-DVT: A Prospective, Multicenter Study of Patients With Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System

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.

Being tested
Indigo Aspiration System
Medical subject headings
Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indigo Aspiration SystemDevice

    Indigo Aspiration System

Study groups in NCT05003843
Study groupRoleWhat they receive
Single ArmOtherUse of Indigo Aspiration System in patients with obstruction due to DVT
Receives: Device: Indigo Aspiration System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 48 Hours Post-Procedure

  2. 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.

    Measured: Index Procedure

Secondary outcomes (3)

  1. Composite of Major Adverse Events

    A composite of death, major bleeding, new symptomatic pulmonary embolism or re-thrombus of the target venous segment

    Measured: 30 Days Post-Procedure

  2. Device Related Adverse Events

    Proportion of participants with device related adverse events

    Measured: 24 Months

  3. Villalta Scale

    Villalta scores reported at baseline, 30 days, 180 days, 12 months, and 24 months

    Villalta score ranges from 0 (no post thrombotic syndrome) to 33 (severe post thrombotic syndrome), with higher scores being worse.

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start30 Sep 2021
  3. Primary completion18 Nov 2025
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05003843
Sponsor's protocol ID
19458
Status last verified
May 2026
First submitted
4 Aug 2021
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Indigo Aspiration System in people with Deep Vein Thrombosis and DVT, run by Penumbra Inc. at 42 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Major Adverse Events (time frame: 48 Hours Post-Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05003843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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