Twenty-Four-Month Safety and Effectiveness of TCD-17187 Drug-Coated Balloon for Treatment of Atherosclerotic Lesions in Superficial Femoral and Proximal Popliteal Artery.

Purpose: In the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients.

Methods: This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled.

Evaluation of the efficacy of combined device strategies for long femoropopliteal artery disease.

One of the major problems associated with bare nitinol stent implantation is stent fracture, particularly in the popliteal artery. The purpose of this study was to determine whether drug coated balloons (DCB), interwoven stents (IWS), or plain old balloon angioplasty (POBA) would be suitable for use in distal femoropopliteal (FP) long lesions when an Eluvia stent was implanted proximal to a lesion. This was a multi-center retrospective study enrolling patients undergoing concomitant use of Eluvia with DCB, IWS or POBA for symptomatic atherosclerotic femoropopliteal disease (lesion length > 15 cm) [Rutherford category 2-6] between January 2018 and September 2021.

Twelve-month safety and effectiveness of TCD-17187 drug-coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery.

Purpose: The aim of this preapproval trial was to evaluate the 12-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA).

Methods: This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled.

Prediction of Technical Failure of Inframalleolar Angioplasty in Patients with Chronic Limb Threatening Ischaemia.

Objective: This study sought to: determine anatomically evaluated predictors of the technical failure of inframalleolar angioplasty (IMA), develop a predictive model for unsuccessful IMA, and investigate the effect of IMA on clinical outcomes in patients with chronic limb threatening ischaemia (CLTI).

Methods: This single centre retrospective observational study enrolled 159 patients with CLTI who underwent IMA for de novo occluded lesions between November 2017 and May 2021. These patients were divided into two groups: the Failed IMA group (n = 62) and the Successful IMA group (n = 97).

A novel endovascular method of atherectomy for calcified common femoral and popliteal disease using the crosser system: Crossbow and Rambow techniques.

Objectives: This study aims to report the efficacy and safety of new atherectomy methods using the Crosser system for calcified lesions in the common femoral and popliteal artery: the Crosser system supported by bended 0.014 wire (Crossbow) technique and retrograde approach of sheathless Crosser system supported by bended 0.014 wire (Rambow) technique.

Combined Treatment With Hyperbaric Oxygen Therapy and Endovascular Therapy for Patients With Chronic Limb-Threatening Ischemia - Study Protocol for the HOTFOOT Multicenter Randomized Controlled Trial.

Hyperbaric oxygen therapy (HBOT) is regarded as one of the therapeutic options added to standard care to improve lower-limb outcomes in patients with chronic limb-threatening ischemia (CLTI). However, the current guidelines specify that HBOT should not be offered instead of revascularization to prevent limb loss in CLTI patients. The aim of the HOTFOOT study is to examine the impact of HBOT on wound healing in CLTI patients after successful endovascular therapy (EVT).

Real-World Clinical Outcomes of IN.PACT Admiral Drug-Coated Balloon for Femoropopliteal Artery Disease - 12-Month Results From Japan Post-Market Surveillance Study.

Background: To confirm the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) based on the indication approved by the Pharmaceuticals and Medical Devices Agency Japan in real-world patients with femoropopliteal artery disease.

Methods and results: IN.

One-year results for Japanese patients in RANGER II SFA.

The RANGER II SFA objective was to evaluate the safety and effectiveness of the Ranger Drug-Coated Balloon (DCB) for treating superficial femoral artery and/or proximal popliteal artery lesions; the purpose of this cohort analysis is to assess the results among Japanese study participants. Patients eligible for RANGER II SFA had symptomatic lower limb ischemia (Rutherford classification 2-4) and were randomly assigned (3:1) to treatment with the Ranger DCB or standard percutaneous transluminal angioplasty (PTA). At 12 months, assessments included freedom from major adverse events (i.

Parallel Wiring Using a Single Intravascular Ultrasound Catheter with Double Rapid Exchange Lumens Technique for Chronic Total Occlusions in Peripheral Artery Disease.

Purpose: To describe a parallel wiring using a single intravascular ultrasound catheter with double rapid exchange lumens (PASSABLE) technique for peripheral CTOs.

Technique: The technique is demonstrated in a 73-year-old patient with CTOs of the superficial femoral and popliteal artery. Intravascular ultrasound (IVUS) examination revealed the first guidewire was advanced to the intramedial space of the popliteal artery.

Prediction of successful guidewire crossing of below-the-knee chronic total occlusions using a Japanese scoring system.

Objective: To develop a scoring system that can adequately predict a successful guidewire crossing (S-GC) of below-the-knee (BTK) chronic total occlusions (CTOs) in angiographic evaluation.

Methods: A retrospective, multicenter, nonrandomized study examined 448 consecutive BTK CTOs in 299 patients treated with endovascular therapy in seven Japanese medical centers from April 2012 to April 2020. The cohort was classified into two groups: an S-GC group and a failed guidewire crossing group.

Mortality risk after use of a paclitaxel-coated stent in femoropopliteal peripheral artery disease.

Although paclitaxel-based devices which demonstrated improved outcomes in the treatment of lower-extremity peripheral artery disease (PAD) have been used worldwide, Katsanos et al. reported a systematic review and summary-level meta-analysis of RCTs in which application of paclitaxel-based devices in the femoropopliteal artery was associated with an increased mortality risk. The purpose of this study was to describe the safety of endovascular therapy (EVT) using paclitaxel-coated stents for femoropopliteal disease by evaluating the mortality risk compared with patients treated with paclitaxel-free devices.

Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty.

Purpose: To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease.

Materials And Methods: The multicenter, prospective, IN.

Outcomes of Pedal Artery Angioplasty Are Independent of the Severity of Inframalleolar Disease: A Subanalysis of the Multicenter RENDEZVOUS Registry.

To examine the efficacy of pedal artery angioplasty (PAA) for chronic limb-threatening ischemia (CLTI) according to the severity of inframalleolar disease. In total, 257 consecutive CLTI patients (mean age 73.2 years; 175 men) with de novo infrapopliteal and inframalleolar artery disease were enrolled from the retrospective RENDEZVOUS registry.

Drug-coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan randomized trial.

Objectives: To assess the longer-term safety and efficacy of the IN.PACT Admiral (MDT-2113) drug-coated balloon (DCB) for the treatment of de novo and non-stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort.

Background: Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non-Caucasian populations.

Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the SM-01 Trial.

Purpose: To report the midterm outcomes of a trial comparing self-expanding nitinol stents to percutaneous transluminal angioplasty (PTA) with provisional stenting in the treatment of obstructive disease in the superficial femoral and popliteal arteries.

Materials And Methods: The SM-01 study ( ClinicalTrials.gov identifier NCT01183117), a single-blinded, multicenter, randomized controlled trial in Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis.

Thrombectomy Using Myocardial Biopsy Forceps in Acute Limb Ischemia Patients.

Purpose: To evaluate the efficacy and safety of thrombectomy using myocardial biopsy forceps for the treatment of acute limb ischemia (ALI).

Materials And Methods: A retrospective review of 11 ALI patients (12 affected limbs, 18 affected vessels) who underwent thrombectomy using biopsy forceps between November 2011 and April 2016 was performed. Of the 12 affected limbs, 2 limbs had stent thrombosis, 1 limb had thrombotic occlusion at a de novo stenosis site, and 9 limbs had embolic ALI.