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The ROADSTER IDE Trial leads to FDA Approval of the First Stent Labeled for Trans Carotid Artery Revascularization (TCAR)
Manish Mehta, MD, MPH1, Vikran Kashyap, MD2, Mahmoud Malas, MD3, Philip Paty, MD1, Richard Cambria, MD4, Christopher Kwolek, MD4, Rasesh Shah, MD5, Enrique Criado, MD6, Robert Molnar, MD7.
1Vascular Health Partners, Queensbury, NY, USA, 2Case Western Reserve, Cleveland, OH, USA, 3John Hopkins, Baltimore, MD, USA, 4Mass General, Boston, MA, USA, 5Sentara Healthcare, Chesapeake, VA, USA, 6University of Michigan, Ann Arbor, MI, USA, 7Michigan University, Flint, MI, USA.

Purpose: Trans Carotid Artery Revascularization (TCAR) with the ENROUTE Trans carotid Neuroprotection System combines direct carotid access with blood flow reversal as cerebral protection during carotid stent placement. The ROADSTER IDE trial studied TCAR using FDA-approved carotid stent systems designed for transfemoral delivery. A subset patient data was used to support FDA approval of a shorter 57cm length delivery system ENROUTE Trans carotid Precise Stent System.
Methods: The ROADSTER IDE trial was a prospective, single-arm, multicenter clinical trial to evaluate the safety and effectiveness of TCAR in high-risk symptomatic patients with ≥50% stenosis and asymptomatic patients with ≥70% stenosis. The primary end point was a composite of stroke (S), myocardial infarction (MI), and death (D) at 30 days. Secondary end points included cranial nerve injury as well as acute device, technical, and procedural success. An independent clinical events committee adjudicated all major adverse events. Of the 67 lead-in and 141 pivotal patients enrolled, 52 patients were treated with the Precise PRO Rx Carotid Stent System. Data from these 52 patients were used to support FDA approval of the shorter length ENROUTE Trans carotid Stent System
Results: From November 2012 to July 2014, 52 patients treated with the Precise Stent were enrolled at 8 of 18 sites that participated in ROADSTER. Mean age was 73.0 years, 42.3% were female, and 23.1% were symptomatic. 51.9% of patients were ≥75 years old, and 23.1% were ≥80 years old. There were no major strokes, myocardial infarctions, deaths or cranial nerve injuries. One patient (1/52, 1.9%) had a minor stroke. Acute device success, technical success and procedural success were 100%, 100% and 98.1% respectively. Of the 15 patients treated at our institution, the technical success was 100%, and the S/D/MI was 0%.
Conclusions: The Precise Stent data from the ROADSTER trial indicates the lowest major adverse events of any carotid stent trials, 0% major stroke/death/MI and a 1.9% minor stroke/death/MI, leading to the FDA approval of the first trans carotid stent. Furthermore, the ROADSTER study highlights that Precise Stent S/D/MI with Trans carotid ENROUTE Neuroprotection (1.9%) is lower than what was observed with Precise Stent Transfemoral Neuroprotection (4.8%) as seen with the SAPPHIRE trial.


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