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Percutaneous Mechanical Thrombectomy Device

Indigo Aspiration System for Deep Vein Thrombosis

N/A
Recruiting
Research Sponsored by Penumbra Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Frontline treatment with Indigo Aspiration System in the target venous segment per Investigator decision
Patient is ≥18 years of age
Must not have
Contraindication to systemic or therapeutic doses of anticoagulants
Treatment of index DVT with thrombolytics within 14 days prior to index procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new device to see if it is safe and effective at treating deep vein thrombosis.

Who is the study for?
This trial is for adults over 18 with a type of blood clot in the leg called Deep Vein Thrombosis (DVT) affecting certain veins. Participants must have had symptoms for less than two weeks and be able to give informed consent. People can't join if they have severe reactions to anticoagulants or contrast dye, life expectancy under one year, high-risk pulmonary embolism, bleeding disorders, are pregnant, or have other conditions that affect study participation.
What is being tested?
The BOLT study is testing the safety and effectiveness of the Indigo Aspiration System. This device is used in a procedure to remove clots from veins in patients with DVT. The goal is to see how well it works when it's the first treatment option chosen by doctors.
What are the potential side effects?
Possible side effects may include pain at the site where the device enters the body, bleeding complications due to mechanical removal of clots, allergic reactions to contrast materials used during venography procedures, and risks associated with blood thinners.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am receiving my first treatment with the Indigo Aspiration System for my vein condition.
Select...
I am 18 years old or older.
Select...
I have a blood clot in my leg that extends to my lower abdomen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot take blood thinners due to health reasons.
Select...
I received clot-dissolving medication for a deep vein thrombosis within the last 14 days.
Select...
I have a birth defect in my IVC or iliac veins.
Select...
I have a misplaced stent in my vein that is blocking blood flow as shown by a vein imaging test.
Select...
My lower large vein in the abdomen is completely blocked.
Select...
I cannot have iodine-based dye for vein imaging, even with pre-treatment.
Select...
I have had a deep vein thrombosis in my leg before.
Select...
I have a blood clotting disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Marder Score
Secondary study objectives
Composite of Major Adverse Events
Device Related Adverse Events
Villalta Scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Use of Indigo Aspiration System in patients with obstruction due to DVT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indigo Aspiration System
2019
N/A
~640

Find a Location

Who is running the clinical trial?

Penumbra Inc.Lead Sponsor
36 Previous Clinical Trials
10,161 Total Patients Enrolled

Media Library

Indigo Aspiration System (Percutaneous Mechanical Thrombectomy Device) Clinical Trial Eligibility Overview. Trial Name: NCT05003843 — N/A
Deep Vein Thrombosis Research Study Groups: Single Arm
Deep Vein Thrombosis Clinical Trial 2023: Indigo Aspiration System Highlights & Side Effects. Trial Name: NCT05003843 — N/A
Indigo Aspiration System (Percutaneous Mechanical Thrombectomy Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05003843 — N/A
~64 spots leftby Dec 2025