BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
M
Matthew Krosin, MD
Primary Investigator
Administratively Closed
18 years or above
All
Phase
N/A
290 participants needed
2 Locations
Brief description of study
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 withbstruction due to deep vein thrombosis (DVT) who are eligible for treatment.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Deep Vein Thrombosis, DVT
-
Age: 18 years or above
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Gender: All
Inclusion Criteria:
- Unilateral lower extremity DVT occlusion involving iliac and/or common femoral veinswith up to 2 cm extension in the inferior vena cava (IVC) or femoral in combinationwith iliac veins, including patients with extension of clot into the contralateralvein
- Acute thrombotic or thromboembolic occlusion with symptom duration of 14 days or less
- Frontline treatment with Indigo Aspiration System in the target venous segment pervestigator 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 adequatelydicated
- 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 mmHgd/or patient on IV vasoactive medication to support blood pressure), or intermediatehigh-risk PE, as defined by the European Society Guideline on management of PE. Lowk PE and/or intermediate low risk PE can be enrolled.
- Known coagulation disorders both acquired (e.g., Heparin Induced Thrombocytopenia,.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable
- Pregnant patients
- Life expectancy <1 year due to comorbidities
- Active cancer: metastatic, progressive, or treated with chemotherapy or radiationherapy in the last 6 months, with the exception of patients with non-melanoma primarykin cancers
- Current participation in another investigational drug or device study that mayund the results of this study. Studies requiring extended follow-up for productshat were investigational but have since become commercially available are notdered investigational studies.
- Other medical, behavioral, or psychological conditions that, in the opinion of thevestigator, precludes the patient from appropriate consent, could limit thebility to participate in the study, including compliance with follow-upquirements, or that could impact the scientific integrity of the study
- Pre-existing malpositioned stent(s) that obstructs the ostium of the index iliac veind contacts the vena cava wall as demonstrated by venography prior to the indexdure
- Congenital anatomic anomalies of the IVC or iliac veins
Updated on
13 Dec 2024.
Study ID: RADY-PENUMBRA-BOLT, 13620
