First‐in‐Man Study of a Novel Peripheral Plaque Atherectomy Device
Introduction Lower extremity atherosclerosis disease (LEAD) is a common peripheral arterial disease with an increasing global incidence, particularly notable in aging societies and countries with a high prevalence of metabolic diseases such as diabetes and hypertension. Epidemiological data indicate that LEAD affects approximately 12%–20% of the elderly population, with the proportion of severe cases also on the rise . The primary causes of LEAD are related to lipid deposition in the arterial wall, chronic inflammatory responses, and endothelial dysfunction, with smoking, high cholesterol, diabetes, and hypertension identified as major risk factors . Typical symptoms of LEAD include intermittent claudication, where patients experience lower extremity pain after walking a certain distance. In severe cases, resting pain, tissue necrosis, or ulcers may occur, potentially leading to amputation. Prognostically, LEAD patients face not only the risk of limb function loss but also a high risk of cardiovascular events, especially coronary heart disease and stroke. Therefore, LEAD has become a major factor contributing to the decline in quality of life and increased mortality globally. Its socioeconomic impact is also significant, as the cost of treating atherosclerosis‐related diseases is substantial, and the long‐term rehabilitation and care needs of patients impose a heavy burden on healthcare systems . The treatment of LEAD includes pharmacotherapy, surgical treatment, and endovascular treatment. Pharmacotherapy mainly involves antiplatelet agents, statins, and vasodilators, which are used to alleviate symptoms and prevent disease progression . Surgical treatment is suitable for severe lesions and commonly includes bypass grafting and endarterectomy . In recent years, endovascular treatment has become the mainstream approach for treating LEAD due to its minimal invasiveness and quick recovery. Endovascular debulking techniques have played an important role in treatment. These methods include laser ablation, atherectomy, and mechanical ablation . Laser ablation uses high‐energy lasers to vaporize plaques, which is suitable for soft plaques but has limited effect on calcified plaques. Atherectomy uses specialized instruments to excise atherosclerotic plaques, making it particularly suitable for calcified lesions; it has the advantage of high precision but is expensive and technically demanding . Mechanical ablation removes plaques through rotation or vibration, suitable for harder lesions, but carries the risk of debris dislodgement, which may cause distal embolism. Currently, the SilverHawk, HawkOne, and TurboHawk atherectomy systems used in clinical practice have achieved certain successes in the endovascular treatment of lower extremity atherosclerosis . However, there are some drawbacks: these systems require a high level of technical skill, necessitating experienced physicians to operate them, and they demand precise control of the device's angle and force to avoid damaging the vessel wall . During the atherectomy procedure, plaque debris may dislodge and enter the distal vasculature, posing a risk of distal embolization. For severely calcified lesions, the cutting capacity of systems like SilverHawk is limited, making it one of the main methods for removing calcified plaques, but it increases the risk of restenosis or requires combination with other treatments . In this study, a new peripheral plaque atherectomy system with a novel design concept was used. It features a distal collecting nose cone to collect cut thrombus and plaque, and four contoured cutting blades designed to handle all types of lesions, including severely calcified lesions. The aim of this study is to evaluate the safety and preliminary efficacy of this peripheral plaque atherectomy system in treating lower extremity arterial calcified lesions. Through a first‐in‐man clinical trial, we hope to demonstrate the system's potential in improving debulking outcomes, reducing intraoperative complications, and enhancing long‐term vessel patency, thereby providing a new option for endovascular treatment of lower extremity atherosclerosis. 

Materials and Methods 2.1 Methods Based on the safety and efficacy of the system and technique, this prospective, non‐randomized, single‐center first‐in‐man (FIM) study was designed to further evaluate the feasibility of the device in human patients. The trial was designed in accordance with the Declaration of Helsinki and was approved by the ethics committee of the Ethics Committee of Xuanwu Hospital (No. [2022]054). 2.2 Inclusion and Exclusion Criteria The inclusion criteria are divided into general inclusion criteria and intraoperative angiography criteria. General inclusion criteria are: (1) Age between 18 and 85 years (inclusive), with no gender restrictions; (2) Patients with symptomatic LEAD, with Rutherford classification between Grades 2 and 5; (3) Willing to participate in this trial, sign the informed consent form, and comply with follow‐up requirements. Intraoperative angiography inclusion criteria are: (1) The reference vessel diameter proximal to the target lesion ≥1.8 mm and (2) Target vessel stenosis ≥70%. The protocol has been approved by the Ethics Committee of Xuanwu Hospital, Capital Medical University, and all patients meeting the criteria provided written informed consent to participate in the trial. The main exclusion criteria are: (1) Presence of a vascular graft in the target vessel; (2) History of target vessel aneurysm, intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction, or stroke within the past two months; (3) Flow‐limiting dissection in or near the proximal or distal part of the target lesion; (4) Uncorrectable coagulation abnormalities (platelet count ≤75×10^9/L or INR ≥2.0), bleeding diathesis, or a history of heparin‐induced thrombocytopenia (HIT); (5) Known allergy to contrast agents or perioperative medications; (6) Participation in other drug or medical device clinical trials; and (7) Pregnant or breastfeeding women. 2.3 Study Device This study utilizes a newly developed peripheral plaque atherectomy system, which works on a principle like a “planer” by advancing a catheter through the target lesion to shave off calcified plaques. The device has undergone relevant animal experiments to confirm its safety and effectiveness, with the experiment number: GXSY2022‐0028. The device mainly consists of an atherectomy catheter and a control handle. The atherectomy catheter includes a cutting handle, delivery catheter, cutting blade, distal collection pouch, tip, and flushing component (Figure ). It features three key elements: A fixed curved shape provides the cutting force for the blade; the control handle provides power to the blade, and the collection pouch provides space for collecting cut calcified plaques. 2.4 Procedure The operators in this FIM trial must have extensive experience in interventional therapy. Specifically, they are required to have at least 5 years of experience in interventional vascular treatment and have performed at least 100 complex peripheral arterial interventions (including atherectomy, balloon angioplasty, and stent placement) to ensure the safety and efficacy of the procedures. To ensure the correct use of the device, we conducted a series of rigorous training sessions for the operators, which were divided into theoretical learning and practical simulation. First, all operators must attend a theoretical training organized by the device development team to understand the device's working principles, indications, contraindications, potential complications, and management methods. Second, operators must complete at least three simulation training sessions to become familiar with the device operation process and prepare for potential emergencies. Only after passing an assessment can they participate in clinical procedures. Patients received dual antiplatelet therapy (aspirin 100 mg/day and clopidogrel 75 mg/day) for at least 3 days preoperatively. Preoperative CT angiography was performed to assess vascular lesions, and the approach was chosen via ipsilateral common femoral artery antegrade puncture or contralateral common femoral artery retrograde puncture. Using the “over‐the‐wire” or “cross‐over” technique, a catheter reached the affected limb, and common femoral artery angiography was performed to determine the lesion's extent. A Treasure 12 guidewire (Asahi, Japan) or V18 guidewire (Boston Scientific, USA) was used in combination with a TrailBlazer support catheter (EV3, USA) to cross stenotic or occluded lesions. Angiography confirmed the true lumen beyond the lesion via the support catheter, and patient eligibility was reassessed. The peripheral plaque atherectomy system was then used if inclusion and exclusion criteria were met. After connecting the device appropriately, the power was turned on, and the catheter head was advanced slowly along the guidewire at a speed of 0.5 cm/s for intravascular lesion debulking. After one operation, the catheter was withdrawn and flushed with heparinized saline. If the debulking result was not satisfactory, the procedure could be repeated once. If angiography confirmed no residual stenosis >30% and no flow‐limiting dissection, a 4.0–5.0 mm drug‐coated balloon (Terumo, China) was introduced for dilation of the lesion area for 3 min. If residual stenosis >30% or flow‐limiting dissection remained, bailout stenting was performed. The operation time varies slightly depending on the patient's specific condition. Preliminary statistics indicate that the average procedure time is approximately 70–140 min, with an average fluoroscopy time of 20–40 min. The average total volume of contrast agent used per procedure is 80–100 mL. These variables specifically depend on the complexity of the arterial lesions, as well as the location and number of plaques. For severe calcified lesions, both the operation and fluoroscopy times may be extended, and the amount of contrast agent used may increase. During the procedure, the team strives to minimize the operation time to reduce the burden on the patient's renal function and the exposure to radiation. 2.5 Endpoints The primary efficacy endpoint is the improvement in the degree of stenosis (DS%) of the target vessel after atherectomy. The primary endpoint event is the 6‐month primary patency rate. Secondary endpoints include clinically driven target lesion revascularization, amputation, and death at 6 months. Safety endpoints include device‐related composite endpoints and major adverse cardiovascular events. Device‐related composite endpoints are defined as intravascular thrombosis, vasospasm, acute occlusion, perforation, and distal embolization. Major adverse cardiovascular events are defined as perioperative acute myocardial infarction and ischemic stroke. Device success is defined as achieving DS <30% at the target site after using the atherectomy system. Procedural success requires DS <30% without the occurrence of device‐related complications (DoCE) during hospitalization. All patients underwent vascular ultrasound follow‐up at 6 months in the outpatient clinic. 2.6 Statistical Analysis Discrete variables are expressed as counts and percentages. Continuous variables are reported as mean ± standard deviation (SD). Student's t ‐test was used to compare pre‐ and post‐treatment data. A p value of <0.05 was considered statistically significant. This study is a FIM and single‐arm study; the sample size was not defined based on endpoint hypotheses but to provide some information on device safety. Primary endpoints and all image‐based findings were analyzed based on the actual treated population. Statistical analysis was performed using SPSS version 23.0 (IBM Corporation, Armonk, NY, USA). 

Methods Based on the safety and efficacy of the system and technique, this prospective, non‐randomized, single‐center first‐in‐man (FIM) study was designed to further evaluate the feasibility of the device in human patients. The trial was designed in accordance with the Declaration of Helsinki and was approved by the ethics committee of the Ethics Committee of Xuanwu Hospital (No. [2022]054). 

Inclusion and Exclusion Criteria The inclusion criteria are divided into general inclusion criteria and intraoperative angiography criteria. General inclusion criteria are: (1) Age between 18 and 85 years (inclusive), with no gender restrictions; (2) Patients with symptomatic LEAD, with Rutherford classification between Grades 2 and 5; (3) Willing to participate in this trial, sign the informed consent form, and comply with follow‐up requirements. Intraoperative angiography inclusion criteria are: (1) The reference vessel diameter proximal to the target lesion ≥1.8 mm and (2) Target vessel stenosis ≥70%. The protocol has been approved by the Ethics Committee of Xuanwu Hospital, Capital Medical University, and all patients meeting the criteria provided written informed consent to participate in the trial. The main exclusion criteria are: (1) Presence of a vascular graft in the target vessel; (2) History of target vessel aneurysm, intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction, or stroke within the past two months; (3) Flow‐limiting dissection in or near the proximal or distal part of the target lesion; (4) Uncorrectable coagulation abnormalities (platelet count ≤75×10^9/L or INR ≥2.0), bleeding diathesis, or a history of heparin‐induced thrombocytopenia (HIT); (5) Known allergy to contrast agents or perioperative medications; (6) Participation in other drug or medical device clinical trials; and (7) Pregnant or breastfeeding women. 

Study Device This study utilizes a newly developed peripheral plaque atherectomy system, which works on a principle like a “planer” by advancing a catheter through the target lesion to shave off calcified plaques. The device has undergone relevant animal experiments to confirm its safety and effectiveness, with the experiment number: GXSY2022‐0028. The device mainly consists of an atherectomy catheter and a control handle. The atherectomy catheter includes a cutting handle, delivery catheter, cutting blade, distal collection pouch, tip, and flushing component (Figure ). It features three key elements: A fixed curved shape provides the cutting force for the blade; the control handle provides power to the blade, and the collection pouch provides space for collecting cut calcified plaques. 

Procedure The operators in this FIM trial must have extensive experience in interventional therapy. Specifically, they are required to have at least 5 years of experience in interventional vascular treatment and have performed at least 100 complex peripheral arterial interventions (including atherectomy, balloon angioplasty, and stent placement) to ensure the safety and efficacy of the procedures. To ensure the correct use of the device, we conducted a series of rigorous training sessions for the operators, which were divided into theoretical learning and practical simulation. First, all operators must attend a theoretical training organized by the device development team to understand the device's working principles, indications, contraindications, potential complications, and management methods. Second, operators must complete at least three simulation training sessions to become familiar with the device operation process and prepare for potential emergencies. Only after passing an assessment can they participate in clinical procedures. Patients received dual antiplatelet therapy (aspirin 100 mg/day and clopidogrel 75 mg/day) for at least 3 days preoperatively. Preoperative CT angiography was performed to assess vascular lesions, and the approach was chosen via ipsilateral common femoral artery antegrade puncture or contralateral common femoral artery retrograde puncture. Using the “over‐the‐wire” or “cross‐over” technique, a catheter reached the affected limb, and common femoral artery angiography was performed to determine the lesion's extent. A Treasure 12 guidewire (Asahi, Japan) or V18 guidewire (Boston Scientific, USA) was used in combination with a TrailBlazer support catheter (EV3, USA) to cross stenotic or occluded lesions. Angiography confirmed the true lumen beyond the lesion via the support catheter, and patient eligibility was reassessed. The peripheral plaque atherectomy system was then used if inclusion and exclusion criteria were met. After connecting the device appropriately, the power was turned on, and the catheter head was advanced slowly along the guidewire at a speed of 0.5 cm/s for intravascular lesion debulking. After one operation, the catheter was withdrawn and flushed with heparinized saline. If the debulking result was not satisfactory, the procedure could be repeated once. If angiography confirmed no residual stenosis >30% and no flow‐limiting dissection, a 4.0–5.0 mm drug‐coated balloon (Terumo, China) was introduced for dilation of the lesion area for 3 min. If residual stenosis >30% or flow‐limiting dissection remained, bailout stenting was performed. The operation time varies slightly depending on the patient's specific condition. Preliminary statistics indicate that the average procedure time is approximately 70–140 min, with an average fluoroscopy time of 20–40 min. The average total volume of contrast agent used per procedure is 80–100 mL. These variables specifically depend on the complexity of the arterial lesions, as well as the location and number of plaques. For severe calcified lesions, both the operation and fluoroscopy times may be extended, and the amount of contrast agent used may increase. During the procedure, the team strives to minimize the operation time to reduce the burden on the patient's renal function and the exposure to radiation. 

Endpoints The primary efficacy endpoint is the improvement in the degree of stenosis (DS%) of the target vessel after atherectomy. The primary endpoint event is the 6‐month primary patency rate. Secondary endpoints include clinically driven target lesion revascularization, amputation, and death at 6 months. Safety endpoints include device‐related composite endpoints and major adverse cardiovascular events. Device‐related composite endpoints are defined as intravascular thrombosis, vasospasm, acute occlusion, perforation, and distal embolization. Major adverse cardiovascular events are defined as perioperative acute myocardial infarction and ischemic stroke. Device success is defined as achieving DS <30% at the target site after using the atherectomy system. Procedural success requires DS <30% without the occurrence of device‐related complications (DoCE) during hospitalization. All patients underwent vascular ultrasound follow‐up at 6 months in the outpatient clinic. 

Statistical Analysis Discrete variables are expressed as counts and percentages. Continuous variables are reported as mean ± standard deviation (SD). Student's t ‐test was used to compare pre‐ and post‐treatment data. A p value of <0.05 was considered statistically significant. This study is a FIM and single‐arm study; the sample size was not defined based on endpoint hypotheses but to provide some information on device safety. Primary endpoints and all image‐based findings were analyzed based on the actual treated population. Statistical analysis was performed using SPSS version 23.0 (IBM Corporation, Armonk, NY, USA). 

Results 3.1 Baseline Clinical Characteristics From March to April 2024, 10 subjects were recruited at our center. All patients met the inclusion criteria and did not meet the exclusion criteria. All patients received treatment for lower extremity vascular lesions with the novel atherectomy system. Demographic data are presented in Table . All patients were male, with a mean age of 61.40 ± 9.17 years. Most patients had comorbidities, including diabetes (80%), hypertension (70%), and hyperlipidemia (80%). Rutherford classification was above Grade 3 in 90% of the patients, and the preoperative ABI (Ankle‐Brachial Index) of the affected side was 0.50 ± 0.14. 3.2 Angiographic and Procedural Characteristics Baseline angiographic characteristics are shown in Table . A total of 10 limbs were included in the trial. Sixty percent of the lesions were in the femoral artery, with an average lesion length of 75.40 ± 50.02 mm. Forty percent of the lesions were chronic total occlusions, and one patient had severely calcified vascular lesions. None of the lesions were associated with thrombosis or ulcerative lesions. One patient developed a flow‐limiting dissection postoperatively, which resolved after stenting. No thrombus or plaque debris was found in the collection pouch at the device tip. Figure shows the angiographic images of femoral and popliteal artery lesions treated with the novel atherectomy system, with restored lower extremity perfusion visible postoperatively. 3.3 Device‐Oriented Composite Endpoints (DoCE) and 6‐Month Follow‐Up Results No device‐related adverse events, such as intravascular thrombosis, vasospasm, acute occlusion, perforation, or distal embolization, occurred during the perioperative period. The device success rate was 100%. All patients were followed for more than 6 months. The primary patency rate at 6 months was 100%, and the clinically driven target lesion revascularization (CD‐TLR) rate was 0%. The mean ABI of the affected limb postoperatively was 0.92 ± 0.12, which showed a statistically significant improvement compared to the preoperative ABI (Figure ). No amputations or major adverse cardiovascular events were observed in these patients, and the overall mortality rate was 0 (0/10) (Table ). 

Baseline Clinical Characteristics From March to April 2024, 10 subjects were recruited at our center. All patients met the inclusion criteria and did not meet the exclusion criteria. All patients received treatment for lower extremity vascular lesions with the novel atherectomy system. Demographic data are presented in Table . All patients were male, with a mean age of 61.40 ± 9.17 years. Most patients had comorbidities, including diabetes (80%), hypertension (70%), and hyperlipidemia (80%). Rutherford classification was above Grade 3 in 90% of the patients, and the preoperative ABI (Ankle‐Brachial Index) of the affected side was 0.50 ± 0.14. 

Angiographic and Procedural Characteristics Baseline angiographic characteristics are shown in Table . A total of 10 limbs were included in the trial. Sixty percent of the lesions were in the femoral artery, with an average lesion length of 75.40 ± 50.02 mm. Forty percent of the lesions were chronic total occlusions, and one patient had severely calcified vascular lesions. None of the lesions were associated with thrombosis or ulcerative lesions. One patient developed a flow‐limiting dissection postoperatively, which resolved after stenting. No thrombus or plaque debris was found in the collection pouch at the device tip. Figure shows the angiographic images of femoral and popliteal artery lesions treated with the novel atherectomy system, with restored lower extremity perfusion visible postoperatively. 

Device‐Oriented Composite Endpoints (DoCE) and 6‐Month Follow‐Up Results No device‐related adverse events, such as intravascular thrombosis, vasospasm, acute occlusion, perforation, or distal embolization, occurred during the perioperative period. The device success rate was 100%. All patients were followed for more than 6 months. The primary patency rate at 6 months was 100%, and the clinically driven target lesion revascularization (CD‐TLR) rate was 0%. The mean ABI of the affected limb postoperatively was 0.92 ± 0.12, which showed a statistically significant improvement compared to the preoperative ABI (Figure ). No amputations or major adverse cardiovascular events were observed in these patients, and the overall mortality rate was 0 (0/10) (Table ). 

Discussion The results of this prospective, single‐center, first‐in‐human study indicate that the novel peripheral plaque atherectomy system is safe and effective in managing symptomatic LEAD. The system operates similarly to a “planer,” successfully removing calcified plaques from stenotic arteries, thereby significantly improving lower extremity blood flow and enhancing clinical outcomes. One notable finding was the high technical success rate (100%) of the atherectomy system, with no device‐related adverse events such as intravascular thrombosis, vasospasm, acute occlusion, or distal embolization observed during the perioperative period. This result indicates the technical reliability of the device, which is capable of completely removing calcified lesions without compromising the integrity of the surrounding vascular structures. A study by Abdel‐Wahab et al.  showed a vascular complication rate of about 3% for high‐speed rotational atherectomy, while excimer laser debulking had a complication rate of around 8%–10%, and drug‐coated balloon (DCB) alone had a complication rate of approximately 15% . The current results indicate that this novel atherectomy system has a lower incidence of associated complications, which may be attributed to its unique structure. As shown in Figure , the device forms an angle ( α ) with the vessel wall, allowing thrombus and calcified plaques within the vessel wall to be easily removed through this angular design. Additionally, the device features a directional knob, enabling precise targeting of both eccentric and concentric plaques. Moreover, the 6‐month primary patency rate reached 100%, with no clinically driven target lesion revascularization (CD‐TLR), which is particularly encouraging considering the complexity of the treated lesions. Approximately 40% of cases were chronic total occlusions, which generally have a poor prognosis due to their challenging characteristics. A study by Keeling et al.  using the SilverHawk atherectomy catheter to treat femoropopliteal atherosclerotic lesions showed a primary patency rate of only 61.7% during an average follow‐up of 5.2 months, as indicated by Doppler ultrasound results. Another observational, non‐randomized, multicenter TALON registry enrolled 601 consecutive patients (353 men; mean age 70 ± 11, range 36–98) with 1258 symptomatic lower extremity atherosclerotic lesions (748 limbs) treated by plaque excision with the SilverHawk catheter, showing a 6‐month rate of survival free of TLR at 90% . SilverHawk is suitable for treating soft plaques and moderately calcified atherosclerotic lesions but has limited efficiency for highly calcified lesions. Moreover, since the operation relies mainly on manual control, surgical time and outcomes can vary depending on the operator's experience. Following SilverHawk, HawkOne, and TurboHawk were introduced with improvements to meet various needs. TurboHawk was launched after SilverHawk and HawkOne to further enhance the ability to manage complex lesions. The TurboHawk device includes multiple cutting modes that can be adjusted based on the type of lesion. It features an enhanced rotational cutter specifically designed for the removal of highly calcified plaques, making it a more powerful device suitable for treating complex and severely calcified atherosclerotic lesions . A retrospective clinical study evaluating the efficacy and safety of TurboHawk in treating lower extremity peripheral vascular disease showed a 6‐month primary patency rate of 93.2%, with no significant difference in patency improvement between claudicants and patients with critical limb ischemia. This study did not evaluate the degree of lesion calcification, and the average lesion length was only 6.6 ± 4.5 cm, which is shorter than the lesion length in the current study. This provides some evidence for the effectiveness of the novel atherectomy system used in this study for calcified lesions . Of course, various issues may arise during the procedure, and we further discuss several potential problems and corresponding solutions. First, the device may become stuck due to severe plaque hardening or calcification. In such cases, the operator can try adjusting the device's angle or reducing the atherectomy speed, and, if necessary, use balloon angioplasty to soften the plaque. For particularly narrow lesions that make it difficult for the guidewire to pass smoothly, a softer guiding wire can be used for pretreatment or balloon pre‐dilation can be applied to increase passage feasibility. Vascular wall injury is a potential risk in all interventional procedures, especially when using atherectomy devices. High‐resolution imaging is used to identify high‐risk areas, and operators are advised to reduce atherectomy speed when approaching these areas. Additionally, a thorough preoperative evaluation of the patient's vascular condition is recommended to select suitable patients and reduce the risk of vascular injury. In this FIM trial, please define the optimal lesion characteristics to ensure the safety and efficacy of the device. Moderate to severe calcified plaques: Since the new atherectomy device is designed to treat moderate to severe calcified arterial plaques, selecting such patients can better validate the efficacy of the device; Moderate lesion length: The ideal lesion length is around 10 cm, allowing for confirmation of the device's efficacy while reducing the complexity of the procedure; Vessels without severe bending or twisting: For vessels with severe bends or twists, the device's deliverability and efficacy may be compromised; therefore, patients with relatively straight vascular structures are preferred. Although the initial cost of the device is relatively high, it helps improve patient's quality of life and reduce the burden on the healthcare system by minimizing repeat treatments, shortening hospital stays, and reducing complication rates. 

Limitations In this first‐in‐man clinical trial of the novel peripheral plaque atherectomy system, although some promising preliminary results were obtained, there are several limitations. First, the study had a small sample size, including only 10 patients (all patients are male), which resulted in low statistical power and may have introduced random bias in the evaluation results. Second, the short follow‐up period made it difficult to fully assess medium‐ and long‐term efficacy and safety, particularly regarding long‐term vessel patency and control of late complications. Additionally, as a single‐center study, there may be center bias, limiting the external validity of the results. The performance may vary among different medical institutions, affecting generalizability. Furthermore, the study lacked a control group, making it difficult to determine differences between the novel atherectomy system and other standard treatment methods, such as balloon angioplasty and stenting. Future larger‐scale, multicenter, long‐term follow‐up randomized controlled studies are needed to further verify the safety and efficacy of this technology and clarify its applicability in the treatment of peripheral artery disease. 

Conclusion The novel atherectomy device demonstrated good safety and efficacy in treating lower extremity arterial disease, achieving a 100% primary patency rate within 6 months without serious adverse events. These results suggest that this system could provide a viable treatment option for calcified arterial lesions, but larger‐scale trials are required to further validate these preliminary findings. 

H.W., J.G., and L.G. initially conceptualized and designed the project. S.C., Z.T., and X.G. were major contributors to data collection and the writing of the manuscript. D.P., Y.G., and H.W. participated in data interpretation and contributed to the writing of the manuscript. All authors have read and approved the final manuscript. 

All patients signed an informed written consent for participation. The trial was approved by the Ethics Committee of Xuanwu Hospital, Capital Medical University ([2022]054). 

The authors declare no conflicts of interest. 

