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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Marder Score
Secondary outcome measures
Composite of Major Adverse Events
Device Related Adverse Events
Villalta Scale
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
35 Previous Clinical Trials
8,820 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take blood thinners due to health reasons.I received clot-dissolving medication for a deep vein thrombosis within the last 14 days.My cancer is spreading, getting worse, or I've had treatment in the last 6 months.I am receiving my first treatment with the Indigo Aspiration System for my vein condition.I have a birth defect in my IVC or iliac veins.I am 18 years old or older.I have a misplaced stent in my vein that is blocking blood flow as shown by a vein imaging test.You have other health problems that make it likely you will not live for more than a year.I have a blood clot in my leg that extends to my lower abdomen.My lower large vein in the abdomen is completely blocked.I cannot have iodine-based dye for vein imaging, even with pre-treatment.I have a pulmonary embolism that is not considered low risk.I have had a deep vein thrombosis in my leg before.I have a blood clotting disorder.You have had a stent placed in the specific vein being studied.I have had a clot-related blockage for 14 days or less.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this research endeavor still open?
"Affirmative. According to clinicaltrials.gov, the study is still in search of participants. This medical trial was first posted on September 30th 2021 and had its most recent update on June 6th 2022. A total of 400 patients need to be enrolled across 2 sites."
Answered by AI
What is the current enrollment of this clinical experiment?
"Affirmative. According to clinicaltrials.gov, the posted medical trial is actively recruiting patients after first being published on September 30th 2021 and updated lastly on June 6th 2022. The study requires 400 participants from 2 distinct sites."
Answered by AI
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