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First-in-Man Experience With the ClearLumen Thrombectomy System as an Adjunctive Therapy in Primary Percutaneous
Luigi Biasco1,2, Matthias Götberg3, Jan Harnek3
1The Heart Centre, Rigshospitalet, Copenhagen, Denmark.
Insights
The ClearLumen Thrombectomy System shows promising safety and efficacy for thrombus aspiration during primary percutaneous coronary intervention (PCI). This novel device offers a feasible option for improving outcomes in ST-elevation myocardial infarction (STEMI) patients.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
- Acute Coronary Syndromes
Background:
- Current thrombus aspiration (TA) devices have limitations in optimizing microvascular perfusion.
- Novel thrombectomy systems are needed to improve treatment efficacy for acute myocardial infarction.
Purpose of the Study:
- To evaluate the safety, feasibility, and efficacy of the ClearLumen Thrombectomy System.
- To assess the ClearLumen system as an adjunctive therapy during primary percutaneous coronary intervention (PCI).
Main Methods:
- Prospective, single-centre, non-randomized trial involving patients with acute ST-elevation myocardial infarction (STEMI).
- The ClearLumen system was used for thrombus aspiration.
- Safety assessed by device-related complications; efficacy by successful deployment and reperfusion.
Main Results:
- The ClearLumen system successfully reached the culprit lesion in 95% of 20 enrolled patients.
- A combined endpoint of successful reperfusion and flow was met in 84.2% of patients.
- Only two minor procedural adverse events occurred post-thrombus aspiration.
Conclusions:
- The ClearLumen Thrombectomy System demonstrates initial promising results for safety and efficacy.
- The system is a feasible adjunctive therapy during primary PCI for STEMI patients.
Objectives:
To describe the first-in-man experience with the ClearLumen Thrombectomy System (Walk Vascular, Irvine, CA) and report on its safety, feasibility and efficacy when used as an adjunctive therapy during primary PCI.
Background:
Thrombus aspiration (TA) aims to improve microvascular perfusion but currently available devices are not optimal.
Methods:
Prospective, single-centre, non-randomized, safety, and efficacy trial. Patients with acute STEMI were enrolled and the investigational device was used for thrombus aspiration. Safety was evaluated as the overall rate of device related complications while efficacy as the rate of successful device deployment and culprit vessel reperfusion. The composite endpoint based on the achievement of at least two of the following three criteria-TIMI flow 3 and/or myocardial blush grade ≥2 at completion of the case and ST-resolution >70% at 90 minutes after vessel reperfusion-was also evaluated.
Results:
Over a 3 months period 20 patients were enrolled in the study. Culprit lesion was successfully reached with the investigational device in 19 patients (95%). The pre-specified combined endpoint was met in 16 out of 19 patients (84.2%). Three patients not meeting the combined end point had procedure related, non TA associated, adverse event. Only 2 minor procedural adverse event occurred after thrombus aspiration.
Conclusions:
This first-in-man experience with the ClearLumen Thrombectomy System demonstrates initial promising results on safety and efficacy when used as an adjunctive therapy during primary PCI.
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