Background and Objectives: Arterial dissection during endovascular therapy rarely occurs but can be lethal. A fabric-based covered graft stents yield poor clinical outcomes. A novel balloon-expandable stent with biodegradable film graft for overcoming these issues was evaluated in a rabbit iliac artery model.Method: Eighteen rabbits with iliac artery dissections were induced by balloon over-inflation on angiography (Ellis type 2 or 3) and treated using the test device (3.0×24 mm). Subsequently, survived twelve animals underwent histologic examinations and micro-computed tomography (CT) at 0, 2, 4, and 8 weeks and 3, 6, 9, and 12 months and angiography at one-year. Results: There were no adverse cardiovascular events during the one-year. Early-stage histologic examination revealed complete sealing of disrupted vessels by the device, exhibiting mural hematoma, peri-stent red thrombi, and dense infiltration of inflammatory cells. Mid- and long-term histologic examination showed patent stents with neointimal hyperplasia over the stents (% area stenosis: 11.8 at 2 weeks, 26.1 at 1 month, 29.7 at 3months, 49.2 at 9 months, and 51.0 at 1 year), along with mild peri-strut inflammatory response (Grade: 1–2 at mid-term and 0–1 at long-term). The graft film became scarcely visible after six months. Both CT and angiography revealed no instances of thrombotic occlusion or in-stent restenosis (% diameter stenosis: 5.7 at 2 weeks, 12.3 at 1 month, 14.2 at 3 months, 25.1 at 9 months, and 26.6 at 1 year). Conclusions The novel balloon-expandable stent with a biodegradable film graft demonstrates feasibility in managing severe artery dissection and preventing lethal vascular events in animal model.

Background and Objectives: The popliteal artery is generally regarded as a “no-stent zone.”Limited data are available on the outcomes of drug-coated balloons (DCBs) for popliteal artery disease. This study aimed to evaluate the 12-month clinical outcomes among patients who received DCB treatment for atherosclerotic popliteal artery disease. Methods: This prospective, multicenter registry study enrolled 100 patients from 7 Korean endovascular centers who underwent endovascular therapy using IN.PACT DCB (Medtronic) for symptomatic atherosclerotic popliteal artery disease. The primary endpoint was 12-month clinical primary patency and the secondary endpoint was clinically driven target lesion revascularization (TLR)–free rate. Results: The mean age of the study cohort was 65.7±10.8 years, and 77% of enrolled patients were men. The mean lesion length was 93.7±53.7 mm, and total occlusions were present in 45% of patients. Technical success was achieved in all patients. Combined atherectomy was performed in 17% and provisional stenting was required in 11%. Out of the enrolled patients, 91 patients completed the 12-month follow-up. Clinical primary patency and TLR-free survival rates at 12 months were 76.0% and 87.2%, respectively. A multivariate Cox regression analysis identified female and longer lesion length as the significant independent predictors of loss of patency. Conclusions DCB treatment yielded favorable 12-month clinical primary patency and TLRfree survival outcomes in patients with popliteal artery disease.

Background and Objectives: Arterial dissection during endovascular therapy rarely occurs but can be lethal. A fabric-based covered graft stents yield poor clinical outcomes. A novel balloon-expandable stent with biodegradable film graft for overcoming these issues was evaluated in a rabbit iliac artery model.Method: Eighteen rabbits with iliac artery dissections were induced by balloon over-inflation on angiography (Ellis type 2 or 3) and treated using the test device (3.0×24 mm). Subsequently, survived twelve animals underwent histologic examinations and micro-computed tomography (CT) at 0, 2, 4, and 8 weeks and 3, 6, 9, and 12 months and angiography at one-year. Results: There were no adverse cardiovascular events during the one-year. Early-stage histologic examination revealed complete sealing of disrupted vessels by the device, exhibiting mural hematoma, peri-stent red thrombi, and dense infiltration of inflammatory cells. Mid- and long-term histologic examination showed patent stents with neointimal hyperplasia over the stents (% area stenosis: 11.8 at 2 weeks, 26.1 at 1 month, 29.7 at 3months, 49.2 at 9 months, and 51.0 at 1 year), along with mild peri-strut inflammatory response (Grade: 1–2 at mid-term and 0–1 at long-term). The graft film became scarcely visible after six months. Both CT and angiography revealed no instances of thrombotic occlusion or in-stent restenosis (% diameter stenosis: 5.7 at 2 weeks, 12.3 at 1 month, 14.2 at 3 months, 25.1 at 9 months, and 26.6 at 1 year). Conclusions The novel balloon-expandable stent with a biodegradable film graft demonstrates feasibility in managing severe artery dissection and preventing lethal vascular events in animal model.

Background and Objectives: The popliteal artery is generally regarded as a “no-stent zone.”Limited data are available on the outcomes of drug-coated balloons (DCBs) for popliteal artery disease. This study aimed to evaluate the 12-month clinical outcomes among patients who received DCB treatment for atherosclerotic popliteal artery disease. Methods: This prospective, multicenter registry study enrolled 100 patients from 7 Korean endovascular centers who underwent endovascular therapy using IN.PACT DCB (Medtronic) for symptomatic atherosclerotic popliteal artery disease. The primary endpoint was 12-month clinical primary patency and the secondary endpoint was clinically driven target lesion revascularization (TLR)–free rate. Results: The mean age of the study cohort was 65.7±10.8 years, and 77% of enrolled patients were men. The mean lesion length was 93.7±53.7 mm, and total occlusions were present in 45% of patients. Technical success was achieved in all patients. Combined atherectomy was performed in 17% and provisional stenting was required in 11%. Out of the enrolled patients, 91 patients completed the 12-month follow-up. Clinical primary patency and TLR-free survival rates at 12 months were 76.0% and 87.2%, respectively. A multivariate Cox regression analysis identified female and longer lesion length as the significant independent predictors of loss of patency. Conclusions DCB treatment yielded favorable 12-month clinical primary patency and TLRfree survival outcomes in patients with popliteal artery disease.

Background: Patients with ischemic stroke may experience early neurological deterioration (END) during the acute phase. This study aimed to identify association between asymptomatic vascular stenosis and END in single subcortical infarction patients. Methods: The study included 562 patients admitted within 48 hours of symptom onset between January 2015 and August 2022. END was defined as a decrease of ≥1 point in the National Institutes of Health stroke scale (NIHSS) motor score or ≥2 points in the total NIHSS score within the first 48 hours after stroke onset. Clinical characteristics, including age, sex, smoking habits, underlying vascular risk factors, initial NIHSS score, trial of Org 10172 in acute stroke treatment classification, laboratory parameters, and presence of vascular stenosis or occlusion, were analyzed to identify predictors of END. Results: END occurred in 115 patients (20%) with single subcortical infarction. Age (odds ratio [OR], 1.0; p=0.011), female sex (OR, 1.7; p=0.042), location of cerebral infarction at corona radiata (OR, 3.0; p=0.023), systolic blood pressure (OR, 1.0; p=0.011) and presence of asymptomatic vascular stenosis (OR, 2.2; p=0.019) were independently associated with END in multivariable logistic regression. Conclusions This study suggests that age, sex, location of cerebral infarction, systolic blood pressure and the presence of asymptomatic vascular stenosis are independent predictors of END.

Background: Patients with ischemic stroke may experience early neurological deterioration (END) during the acute phase. This study aimed to identify association between asymptomatic vascular stenosis and END in single subcortical infarction patients. Methods: The study included 562 patients admitted within 48 hours of symptom onset between January 2015 and August 2022. END was defined as a decrease of ≥1 point in the National Institutes of Health stroke scale (NIHSS) motor score or ≥2 points in the total NIHSS score within the first 48 hours after stroke onset. Clinical characteristics, including age, sex, smoking habits, underlying vascular risk factors, initial NIHSS score, trial of Org 10172 in acute stroke treatment classification, laboratory parameters, and presence of vascular stenosis or occlusion, were analyzed to identify predictors of END. Results: END occurred in 115 patients (20%) with single subcortical infarction. Age (odds ratio [OR], 1.0; p=0.011), female sex (OR, 1.7; p=0.042), location of cerebral infarction at corona radiata (OR, 3.0; p=0.023), systolic blood pressure (OR, 1.0; p=0.011) and presence of asymptomatic vascular stenosis (OR, 2.2; p=0.019) were independently associated with END in multivariable logistic regression. Conclusions This study suggests that age, sex, location of cerebral infarction, systolic blood pressure and the presence of asymptomatic vascular stenosis are independent predictors of END.

Background and Objectives: Arterial dissection during endovascular therapy rarely occurs but can be lethal. A fabric-based covered graft stents yield poor clinical outcomes. A novel balloon-expandable stent with biodegradable film graft for overcoming these issues was evaluated in a rabbit iliac artery model.Method: Eighteen rabbits with iliac artery dissections were induced by balloon over-inflation on angiography (Ellis type 2 or 3) and treated using the test device (3.0×24 mm). Subsequently, survived twelve animals underwent histologic examinations and micro-computed tomography (CT) at 0, 2, 4, and 8 weeks and 3, 6, 9, and 12 months and angiography at one-year. Results: There were no adverse cardiovascular events during the one-year. Early-stage histologic examination revealed complete sealing of disrupted vessels by the device, exhibiting mural hematoma, peri-stent red thrombi, and dense infiltration of inflammatory cells. Mid- and long-term histologic examination showed patent stents with neointimal hyperplasia over the stents (% area stenosis: 11.8 at 2 weeks, 26.1 at 1 month, 29.7 at 3months, 49.2 at 9 months, and 51.0 at 1 year), along with mild peri-strut inflammatory response (Grade: 1–2 at mid-term and 0–1 at long-term). The graft film became scarcely visible after six months. Both CT and angiography revealed no instances of thrombotic occlusion or in-stent restenosis (% diameter stenosis: 5.7 at 2 weeks, 12.3 at 1 month, 14.2 at 3 months, 25.1 at 9 months, and 26.6 at 1 year). Conclusions The novel balloon-expandable stent with a biodegradable film graft demonstrates feasibility in managing severe artery dissection and preventing lethal vascular events in animal model.

Background and Objectives: The popliteal artery is generally regarded as a “no-stent zone.”Limited data are available on the outcomes of drug-coated balloons (DCBs) for popliteal artery disease. This study aimed to evaluate the 12-month clinical outcomes among patients who received DCB treatment for atherosclerotic popliteal artery disease. Methods: This prospective, multicenter registry study enrolled 100 patients from 7 Korean endovascular centers who underwent endovascular therapy using IN.PACT DCB (Medtronic) for symptomatic atherosclerotic popliteal artery disease. The primary endpoint was 12-month clinical primary patency and the secondary endpoint was clinically driven target lesion revascularization (TLR)–free rate. Results: The mean age of the study cohort was 65.7±10.8 years, and 77% of enrolled patients were men. The mean lesion length was 93.7±53.7 mm, and total occlusions were present in 45% of patients. Technical success was achieved in all patients. Combined atherectomy was performed in 17% and provisional stenting was required in 11%. Out of the enrolled patients, 91 patients completed the 12-month follow-up. Clinical primary patency and TLR-free survival rates at 12 months were 76.0% and 87.2%, respectively. A multivariate Cox regression analysis identified female and longer lesion length as the significant independent predictors of loss of patency. Conclusions DCB treatment yielded favorable 12-month clinical primary patency and TLRfree survival outcomes in patients with popliteal artery disease.

Background: Patients with ischemic stroke may experience early neurological deterioration (END) during the acute phase. This study aimed to identify association between asymptomatic vascular stenosis and END in single subcortical infarction patients. Methods: The study included 562 patients admitted within 48 hours of symptom onset between January 2015 and August 2022. END was defined as a decrease of ≥1 point in the National Institutes of Health stroke scale (NIHSS) motor score or ≥2 points in the total NIHSS score within the first 48 hours after stroke onset. Clinical characteristics, including age, sex, smoking habits, underlying vascular risk factors, initial NIHSS score, trial of Org 10172 in acute stroke treatment classification, laboratory parameters, and presence of vascular stenosis or occlusion, were analyzed to identify predictors of END. Results: END occurred in 115 patients (20%) with single subcortical infarction. Age (odds ratio [OR], 1.0; p=0.011), female sex (OR, 1.7; p=0.042), location of cerebral infarction at corona radiata (OR, 3.0; p=0.023), systolic blood pressure (OR, 1.0; p=0.011) and presence of asymptomatic vascular stenosis (OR, 2.2; p=0.019) were independently associated with END in multivariable logistic regression. Conclusions This study suggests that age, sex, location of cerebral infarction, systolic blood pressure and the presence of asymptomatic vascular stenosis are independent predictors of END.

Background and Objectives: Arterial dissection during endovascular therapy rarely occurs but can be lethal. A fabric-based covered graft stents yield poor clinical outcomes. A novel balloon-expandable stent with biodegradable film graft for overcoming these issues was evaluated in a rabbit iliac artery model.Method: Eighteen rabbits with iliac artery dissections were induced by balloon over-inflation on angiography (Ellis type 2 or 3) and treated using the test device (3.0×24 mm). Subsequently, survived twelve animals underwent histologic examinations and micro-computed tomography (CT) at 0, 2, 4, and 8 weeks and 3, 6, 9, and 12 months and angiography at one-year. Results: There were no adverse cardiovascular events during the one-year. Early-stage histologic examination revealed complete sealing of disrupted vessels by the device, exhibiting mural hematoma, peri-stent red thrombi, and dense infiltration of inflammatory cells. Mid- and long-term histologic examination showed patent stents with neointimal hyperplasia over the stents (% area stenosis: 11.8 at 2 weeks, 26.1 at 1 month, 29.7 at 3months, 49.2 at 9 months, and 51.0 at 1 year), along with mild peri-strut inflammatory response (Grade: 1–2 at mid-term and 0–1 at long-term). The graft film became scarcely visible after six months. Both CT and angiography revealed no instances of thrombotic occlusion or in-stent restenosis (% diameter stenosis: 5.7 at 2 weeks, 12.3 at 1 month, 14.2 at 3 months, 25.1 at 9 months, and 26.6 at 1 year). Conclusions The novel balloon-expandable stent with a biodegradable film graft demonstrates feasibility in managing severe artery dissection and preventing lethal vascular events in animal model.