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

Penumbra

Status

Enrolling

Conditions

Deep Vein Thrombosis

DVT

Treatments

Device: Indigo Aspiration System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05003843

19458

Details and patient eligibility

About

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.

Enrollment

290 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
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 Thrombocytopenia, etc.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable state
Pregnant patients
Life expectancy <1 year due to comorbidities
Active cancer: metastatic, progressive, or treated with chemotherapy or radiation therapy in the last 6 months, with the exception of patients with non-melanoma primary skin cancers
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