BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis (NCT05003843) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
United States229 participantsStarted 2021-09-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Thrombocytope…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.