Peripheral artery disease (PAD) caused by atherosclerotic stenosis or occlusion of the arteries of the lower extremities is a major global health concern. Despite advances in endovascular therapies, treating complex lesions such as heavily calcified segments and chronic total occlusions remains challenging, which limits procedural success and long-term patency. The novel 355-nm cold laser atherectomy (CLA) system offers a photochemical, low-thermal approach to plaque ablation, with potential advantages in safety and efficacy. The aim of this study was to evaluate the safety and efficacy of a 355-nm CLA system for treating lower limb atherosclerotic stenosis and occlusion in a prospective, multicenter, randomized controlled trial. This trial enrolled 110 patients with symptomatic lower extremity PAD (Rutherford classes 2-5) and ≥70% stenosis or occlusion. Patients were randomly assigned to the CLA and excimer laser atherectomy (ELA) groups. The primary endpoint was improvement in vessel diameter stenosis (DS%) prior to any adjunctive therapy. Secondary endpoints included primary patency, target lesion revascularization (TLR), Rutherford classification improvement, and ankle-brachial index values at 30 days and 6 months postoperatively, as well as a device-oriented composite endpoint. A total of 109 patients (CLA, n = 58; ELA, n = 51) were included in the analysis. Baseline demographics and comorbidities were well balanced between the groups. Postprocedural DS% improved significantly in both groups, with no significant intergroup differences (CLA, 59.92% ± 15.02%; ELA, 57.52% ± 17.22%; P = 0.438). The mean improvement in DS% (CLA, 34.28%; ELA, 34.35%) met the noninferiority threshold. At 30 days, the primary patency rates were 85.1% (CLA) and 87.8% (ELA), with TLR rates of 0.0% and 1.9%, respectively. At 6 months, patency decreased to 71.7% (CLA) and 61.5% (ELA), and TLR occurred in 6.5% and 10.2% of patients, respectively (P = 0.698). Ankle-brachial index values and Rutherford classification improved similarly in the 2 groups. Subgroup analyses revealed that for TASC (Trans-Atlantic Inter-Society Consensus) C/D and long lesions (≥10 cm), CLA had lower TLR rates at 6 months (P < 0.05), suggesting potential advantages for complex lesions. The 355-nm CLA system showed similar safety and efficacy to the excimer laser, with a trend toward reducing TLR in complex PAD lesions. These findings highlight its potential as a next-generation endovascular tool that could refine revascularization strategies and improve patient outcomes in clinical practice. (DCB for Dialysis Access Stent Graft Restenosis; NCT03360279).

Objectives A New Ultra-Low Pulse width 355 nm Solid-State Laser Shows Superior Performance to 308 nm Lasers in Preclinical Trials. Real-world statistics, however, are currently scarce. The purpose of this study is to assess the CLA-355 nm laser system’s clinical safety and feasibility in human trials. Methods This study is a prospective, non-randomized, first-in-human trial. The main inclusion criterion was patients with peripheral artery disease (PAD), and the main exclusion criterion was the presence of vascular grafts in the target vessel. Enrolled patients received treatment with the 355 nm Laser Plaque Ablation System (Shenzhen Vivolight, China) in combination with a drug-coated balloon (Endovastec, China) during hospitalization. Efficacy was assessed by the improvement in the percent diameter stenosis (DS) of the target vessel after laser ablation. The primary endpoint was the 6-month primary patency, while secondary endpoints included 6-month clinically driven target lesion revascularization (CD-TLR), amputation, and death. Safety endpoints included device-oriented clinical events (MoCEs) and major adverse cardiovascular events. Results Nine patients (10 limbs affected) were enrolled in this study; their average age was 69.55 ± 7.99 years, and 44.44% of the patients were male. The femoral artery contained 60% of the lesions, 70% of which were eccentric, and the average lesion length was 49.13 ± 53.87 mm. Chronic occlusive lesions accounted for 40% of lesions. One patient had vascular lesions that were extensively calcified, and the other patient had an aneurysm. Thrombosis and ulcerative lesions were absent from every lesion. Prior to the treatment, the minimal vessel diameter was 0.53 ± 0.68 mm, and the DS was 88.09 ± 15.26%. The reference vessel had a diameter of 4.22 ± 0.69 mm. The residual stenosis after laser atherectomy was 47.94 ± 16.78%, with a minimum lumen diameter of 2.26 ± 0.75 mm. Following the procedure, after subsequent DCB angioplasty, the DS was reduced to 26.07 ± 6.411% with a minimal vessel diameter of 3.00 ± 0.54 mm. During the perioperative phase, there were no MoCEs (distal embolization, perforation, acute occlusion, vasospasm, or intravascular thrombosis). 90% of patients remained patent after six months, and CD-TLR was 100% free. None of the patients experienced MACEs, amputations, or any other problems. Conclusions This is the first exploratory study on treating PAD in people using the CLA-355 nm laser plaque ablation device. According to preliminary findings, this device exhibits good safety and feasibility in plaque ablation.

Objectives: The aim of this study was to evaluate the one-year results of the Eluvia drug-eluting vascular stent (Boston Scientific, Marlborough, MA, USA) for the treatment of femoropopliteal occlusive disease (FPOD). Methods: From January 2021 to November 2023, this multicenter study prospectively enrolled patients with peripheral artery disease involving the femoropopliteal artery. The primary outcome measures were the rate of freedom from clinically driven target limb revascularization (f-CD-TLR), rate of freedom from major adverse events (f-MAE), rate of freedom from symptom recurrence (f-SR) and rate of freedom from all-cause death (f-ACD). The secondary outcome measures were the Rutherford grade and Vascular Quality of Life (VascuQoL) scale scores. Results: In total, 159 patients were enrolled in this study. The mean follow-up time was 370 days, and the follow-up rate was 83.0%. The patients’ mean age was 72 years, and 82.4% were male. A total of 159 patients received 199 stent deployments. The mean lesion length was 194.4 ± 118.9 mm, and 76.7% had total occlusions. The technical success rate for endovascular treatment was 100%, and five complications occurred during the perioperative period. At one, three, six, and 12 months, the f-CD-TLR rate was 99.3%, 97.9%, 96.4%, and 92.8%, respectively; the f-MAE rate was 98.0%, 96.7%, 93.1%, and 91.3%, respectively; the f-SR rate was 94.6%, 85.5%, 80.3%, and 73.4%, respectively; and the f-ACD rate was 98.0%, 98.0%, 95.9% and 94.1%, respectively. There was a substantial increase in the Rutherford grade and average VascuQoL scores at the one-, three-, six-, and 12-month follow-ups ( p < .001). Conclusions: The Eluvia stent had a favorable effect on FPOD throughout 12 months of follow-up. Further studies with larger sample sizes and longer-term follow-up are required to confirm the real-world performance of the Eluvia stent.

Objective: The objective of this study was to investigate the relationship between preoperative below-the-knee (BTK) runoff and major adverse limb event (MALE)-free survival, as well as clinically-driven target lesion revascularization (CD-TLR) and all-cause mortality, in patients with femoropopliteal occlusive disease (FPOD) treated with drug-coated balloons (DCB). Methods: A large-scale, multicenter, prospective study was initiated in January 2021. Endpoint outcomes were obtained prior to December 31, 2024. The exposure of interest was BTK runoff, with the primary endpoint being MALE-free survival, and secondary endpoints being CD-TLR and all-cause mortality. Multivariate Cox regression was employed to control for confounding variables, and stratified analyses were conducted. Results: A total of 1757 participants (36.1% male) with a mean (SD) age of 71.2 (9.5) years were enrolled in the study. The median follow-up duration was 1.5 years. In the fully adjusted model, 1 runoff, 2 runoff and 3 runoff were associated with significantly lower incidences of MALE or death compared with 0 runoff (1 runoff: hazard ratio [HR]=0.75, 95% confidence interval [CI]: 0.56, 1.00, p=0.054; 2 runoff: HR = 0.63, 95% CI: 0.46, 0.87, p=0.006; 3 runoff: HR=0.49, 95% CI: 0.34, 0.72, p<0.001). In addition, 3 runoff demonstrated a lower incidence of CD-TLR (HR=0.56, 95% CI: 0.35, 0.90, p=0.017) and all-cause mortality (HR=0.47, 95% CI: 0.25, 0.89, p=0.021) compared with 0 runoff. There was a significant trend toward reduction in the incidence of all 3 endpoints with increasing numbers of BTK runoff vessels (p for trend <0.05). The relationship between BTK runoff and the endpoints was consistent across all subgroups, with no significant interaction observed. Conclusions: In patients with FPOD treated with DCB, a higher number of BTK runoff vessels was significantly associated with fewer MALE or death, fewer CD-TLR, and fewer deaths. This association was independent of traditional cardiovascular risk factors and represents an important stratification factor for patient outcomes (The PROMISING Study, NCT04826705). Clinical Impact: This large, prospective multicenter study demonstrates that preoperative below-the-knee (BTK) runoff remains a strong and independent prognostic factor in patients undergoing femoropopliteal drug-coated balloon (DCB) therapy. Despite the antiproliferative benefits of DCBs, distal hemodynamics continue to influence procedural durability and long-term limb outcomes. Our findings show a graded reduction in MALE, CD-TLR, and mortality with increasing runoff vessels, independent of lesion complexity, stent implantation, and concomitant outflow intervention. These results reinforce the importance of systematic preprocedural runoff assessment and support incorporating BTK runoff into risk stratification, patient counseling, and surveillance planning in contemporary endovascular practice.

Endovascular embolization (EE) has become an effective method for the treatment of intractable epistaxis (IE). However, complications such as facial pain, headaches, aphasia, hemiplegia, and transient blindness can also occur during or after surgery. In this article, we report a rare case of IE with residual intravascular guidewire after EE. Open surgery was used to remove the guidewire. However, to avoid serious complications such as massive hemorrhage, only part of the guidewire was removed.

This first‐in‐man (FIM) study evaluated the feasibility and safety of a new peripheral plaque atherectomy system in patients with symptomatic lower extremity artery disease (LEAD). Ten patients with symptomatic LEAD (Rutherford class 2–5) were enrolled in a prospective, single‐center study from March to April 2024. Patients aged 18–85 years with target lesions showing ≥70% stenosis and reference vessel diameters ≥1.8 mm underwent treatment using a novel atherectomy device with a “shaving” mechanism to excise calcified plaques. Outcomes included post‐procedural stenosis improvement, 6‐month primary patency rate, and safety endpoints such as thrombosis, vasospasm, acute occlusion, and distal embolization. Statistical analysis used SPSS 23.0. Ten male patients (mean age: 61.4 ± 9.2 years) were treated. Most had diabetes (80%), hypertension (70%), and hyperlipidemia (80%). Pre‐procedural ankle‐brachial index (ABI) averaged 0.50 ± 0.14. Angiographic analysis showed 60% of lesions in the femoral artery and 40% as chronic total occlusions. No major adverse events occurred, with 100% technical success. Post‐procedural ABI improved to 0.92 ± 0.12 (p < 0.05). At 6 months, the primary patency rate was 100%, with no clinically‐driven revascularization or adverse cardiovascular events. Mortality was 0%. All patients reported significant improvement in symptoms and walking distance, as well as enhanced quality of life and reduced pain during physical activity. The novel atherectomy device showed promising safety and efficacy for treating calcified LEAD. Larger‐scale trials are needed to confirm these outcomes.