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Clinical Trial
. 2016 Oct 10;9(19):2058-2064.
doi: 10.1016/j.jcin.2016.07.002. Epub 2016 Sep 14.

Feasibility and Safety of Robotic Peripheral Vascular Interventions: Results of the RAPID Trial

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Clinical Trial

Feasibility and Safety of Robotic Peripheral Vascular Interventions: Results of the RAPID Trial

Ehtisham Mahmud et al. JACC Cardiovasc Interv. .

Abstract

Objectives: The goal of this study was to evaluate the feasibility and safety of a robotic-assisted platform (CorPath 200, Corindus Vascular Robotics, Waltham, Massachusetts) for treating peripheral artery disease.

Background: A robotic-assisted platform for percutaneous coronary intervention is available for treating coronary artery disease.

Methods: In this prospective single-arm trial, patients with symptomatic peripheral artery disease (Rutherford class 2 to 5) affecting the femoropoplital artery were enrolled. Endpoints evaluated were: 1) device technical success, defined as successful cannulation of the target vessel with the robotic system; 2) device safety, defined as absence of device related serious adverse event (hospitalization, prolonged hospitalization, life threatening, or resulted in death); and 3) clinical procedural success, defined as <50% residual stenosis without an unplanned switch to manual assistance or device-related serious adverse event in the periprocedural period.

Results: The study enrolled 20 subjects (65.5 ± 9.3 years of age; 70% male) with primarily Rutherford class 2 to 3 (90%) symptoms. A total of 29 lesions (lesion length: 33.1 ± 15.5 mm) were treated with the majority (89.7%) being located in the superficial femoral artery. Device technical success, safety and clinical procedural success were all 100% with provisional stenting required in 34.5% of lesions. Fluoroscopy time (7.1 ± 3.2 min) and contrast use (73.3 ± 9.2 ml) compared favorably with studies in similar patient cohorts. There were no adverse events associated with the use of the robotic system.

Conclusions: These data demonstrate the feasibility and safety of using a robotic-assisted platform for performing peripheral arterial revascularization.

Keywords: PVI; interventions; peripheral artery disease; robotic assisted.

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