Radial Approach Evaluated With Terumo’s R2P Misago Stent to Treat Complex Lower Extremity PAD

September 27, 2022—Terumo Medical Corporation recently announced data demonstrating the safety and efficacy of radial to peripheral interventions with the company’s R2P Misago self-expanding peripheral stent in lower extremity endovascular interventions via a radial approach.

The device is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or occlusions of the superficial femoral artery and/or proximal popliteal artery with reference vessel diameters of 4 to 7 mm and lesion lengths up to 150 mm.

According to the company, the study results showed that using a radial approach in treatment of complex lower extremity peripheral artery disease (PAD) allowed 92.3% of patients to be discharged the same day. In addition, there were no serious access site complications for any patients enrolled in the study.

Yulanka Castro-Dominguez, MD, with University Hospitals Harrington Heart & Vascular Institute in Cleveland, Ohio, presented the findings at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts.

According to Terumo, the prospective, multicenter, single-arm study sought to evaluate the safety and feasibility of radial access when used in the treatment of complex lower extremity PAD. Investigators enrolled 120 patients with PAD (Rutherford class, 2-5) at eight medical centers in the United States from June 29, 2020, to June 24, 2021. Patients were followed-up to 1 year.

The study was core-lab reviewed and adjudicated by a clinical endpoint committee (CEC).

In the final analysis, the primary safety endpoint included evaluation of radial access–related complications (access site bleeding, hand ischemia, hematoma, nerve damage, perforation, pseudoaneurysm, radial artery occlusion, embolic stroke, or transient ischemic attack).

Based on CEC adjudication, primary safety events categorized as serious access site–related adverse events did not occur in any patient. Radial access was successfully achieved in 100% of patients, reported Terumo.

The company noted that patients who received an R2P Misago self-expandable bare-metal stent were later followed-up to 12 months, with reintervention on the target lesion required in two patients.

According to the company, dedicated Terumo radial devices used in this study included the R2P Destination slender guiding sheath, R2P Metacross RX percutaneous transluminal angioplasty (PTA) balloon dilatation catheter, R2P Crosstella RX PTA balloon dilatation catheter, R2P Misago self-expandable bare-metal stent, and TR Band radial compression device.