Background and Purpose Annual stroke rates might be as high as 10% to 24% in patients with symptomatic intracranial stenosis on best medical therapy. Angioplasty with stent for symptomatic intracranial stenosis trial ...Background and Purpose Annual stroke rates might be as high as 10% to 24% in patients with symptomatic intracranial stenosis on best medical therapy. Angioplasty with stent for symptomatic intracranial stenosis trial Ⅰ (ASSIST-Ⅰ) was a prospective and nonrandomized feasibility and safety study to evaluate the APOLLO Stent System for treatment of symptomatic intracranial artery stenosis, and prepare for ASSIST Ⅱ-a prospective, multicenter,and randomized controlled-study. The APOLLO stent delivery system (MicroPort Medical [Shanghai] Limited Co.), specifically designed for intracranial artery stenosis, consists of a stent and a balloon and a rapid-exchange delivery catheter. The stent is made of 316L stainless steel, with diameters of 2.0 to 4.0 mm and length of 8 mm or 13 mm. Only two links connect the rings of 1 mm in length, rendering the stent a good flexibility enough to navigate tortuous intracranial vessels. The nominated pressure of the stent is designed at 6 atm to reduce the risk of occlusion to side branches and perforators and rupture and dissection of target vessel. The crimping technique is applied in this system, insuring a compact ability of stent so wonderful that the struts of stent do not lift when the stent negotiates a turn, which lessen the likelihood of vessel wall injury and stent migrating. Materials and methods Thirty-four patients with 35 symptomatic intracranial stenoses of ≥50%, which resulted in transient ischemic attacks (TIAs [23 lesions /22 patients]) and minor stroke (7 lesions/7 patents), and both TIAs and stroke (5 lesions/ 5 patients), and with 1 asymptomatic severe stenosis, were enrolled in ASSIST-Ⅰ from December 10, 2003 to August 12, 2004. Their age was 54.3 years±SD of 9.49, three patients were male, and all had ≥1 risk factors of atherosclerosis. Patients received the evaluation of National Institutes of Health Stroke Scale (NIHSS), modified Rankin scale (mRS )and Barthel idex (BI) before and one-, three-, six-, and 12-month after the procedure. Results Stent success, defined as stent-assisted angioplasty successfully, resulting in ≤20% residual stenosis, was obtained in 35 lesions ( 97.2%, 35/36) and 33 patients ( 97.1%, 33/34). The stenosis rate of pre- and post -procedure was 80.5%± SD of 12.65 and 7.4%±SD 15.74, respectively. The Procedure-related complications were 8.3% for lesion (3/36) and 8.8% for patient (3/34), included 1 acute thrombosis, which obtained complete patency by means of intrathrombus thombolysis at once without sequelae, and 2 ischemic perforator strokes (1 irreversible stroke and 1 reversible). The disable stroke, defined as one that led to mRS score of ≥2, 30 days after the stroke, occurred in one patient ( 2.9%, 1/34; mRS of 2). Procedure success, defined as stent success without disable stroke or death at discharge by means of the endovascular therapy, was achieved in 33 lesions ( 91.7%, 33/36) and in 31 patients ( 91.2%, 31/34). Treatment success, defined as stent success without disable stroke and death at the 30th day, by means of the endovascular and medical therapy, was obtained in 34 lesions ( 94.4%, 34/36) and 32 patients ( 94.1%, 32/34). Clinical Follow-up, median 170 days (ranged from 30 days to 273 days; ≥1 month, n=34; ≥3 months, n=23; ≥6 months, n=13), was performed in 34 patients. There were no ischemic neurological events and death occurred. Cumulated disable stroke occurred in 1 patient ( 2.9%, 1/34). NIHSS was 1.09±SD of 1.694 and 0.47±SD of 1.051, before procedure and at the 30th day (n=34), respectively, and 0.57±SD of 0.992 at 3 months (n=23), 0.15±SD of 0.376 at 6 months (n=13), respectively; mRS was 0.65±SD of 0.812 and 0.47±SD of 0.563, before procedure and at 30 days, respectively, and 0.61±SD of 0.583 at 3 months, 0.38±SD of 0.506 at 6 months, respectively; and BI was 97.54±SD of 5.918 and 99.26±SD of 2.179, before procedure and at 30 days, respectively, and 99.35±SD of 2.288 at 3 months, 100.00±SD展开更多
Background and Purpose Annual stroke rates might be as high as 10% to 24% in patients with symptomatic intracranial stenosis in spite of best medical therapy. This was a single center, nonrandomized prospective study ...Background and Purpose Annual stroke rates might be as high as 10% to 24% in patients with symptomatic intracranial stenosis in spite of best medical therapy. This was a single center, nonrandomized prospective study to evaluate the safety, feasibility and clinical efficacy of stenting for patients with symptomatic intracranial stenosis. Methods One hundred and fifty-five consecutive patients with 170 symptomatic intracranial stenoses of ≥50%, resulted in transient ischemic attacks or minor stroke, were enrolled from September 5, 2001 to August 12, 2004. Their age was 50.9 years±SD of 12.98, 132 patients were male and 150 had ≥1 risk factors of atherosclerosis. The “offending” lesions were situated at middle cerebral (n=93), intracranial internal carotid (n=19), basilar (n=29), intracranial vertebral (n=28) and posterior inferior cerebellar (n=1). Patients received neurological evaluation with National Institutes of Health Stroke Scale (NIHSS) score before and immediately after procedure, and one-, three-, six-, and 12-month after the procedure. Disable stroke was defined as one that led to a modified Rankin scale (mRS) score of ≥2. 1. Results of the Periprocedural Period: Total of 177 balloon-expandable stents was used. Stent Success, defined as stent-assisted angioplasty successfully, resulting in ≤20% residual stenosis, was obtained in 157 lesions ( 92.4%, 157/170) and 142 patients ( 91.2%, 142/155). The stenosis rate of pre- and post -procedure for all patients was 78.2%±SD of 13.93 and 10.8%±SD 20.77, respectively The Procedure-related Complications were 11.8% for lesion (20/170) and 12.9% for patients (20/155), including 6 acute / subacute occlusions and 1 asymptomatic dissection, which all obtained complete patency by means of endovascular therapy at once without sequelae; 6 intracranial hemorrhage, 3 of them recovered (NIHSS at 30-day ≤pre-procedure’s) and one remained hemiparesis with 2 points on NIHSS score at the discharging time, and two died; 1 TIA , disappeared after 3 days; 1 reversible and 4 irreversible ischemic penetrator strokes, and1 irreversible embolic stroke . The rate of complications in stent success group (G1) was 13.4% (19/142) compared with 7.7% (1/13) in stent failure group (G2). The rates of disable stroke (n=5) and death (n=2) within 30 days were 4.5% (7/155) for total patients, 4.9% in G1 (7/142), and 0 in G 2(0/13), respectively. Endovascular Procedure Success was achieved in 144 lesions ( 84.7%, 144/170) and in 129 patients ( 83.2%, 129/155). Procedure success was defined as stent success without disable stroke or death at discharge by means of endovascular therapy, in spite of complications, such as acute / subacute occlusion or dissection. Treatment Success, defined as stent success without inability stroke and death at the 30 th day, by means of endovascular and medical therapy, was obtained in 150 lesions ( 88.2%, 150/170) and in 135 patients ( 87.1%, 135/155). 2. Results of Clinical and Angiographic Follow-up: Clinical Follow-up, median 344 days (ranged from 30 days to 1057 days, 378 days ± SD of 270.2), was performed in 150 patients (140 in G1 and 10 in G2). Ischemic neurological events in the distribution of the target lesion occurred in 5 patients ( 3.3%, 5/150), including 2 strokes and 1 death ( 2.0%, 3/150), and 2 TIAs ( 1.3%, 2/150) during the follow-up. Death and stroke ( 20.0%, 2/10), and TIAs ( 10.0%, 1 /10) in G2 were higher than that in G1 ( 0.7%, 1/140 and 0.7%, 1/140, respectively) after one month. Cumulated neurological events occurred in 15.5% (24/155) of total patients, included TIAs in 3( 1.9%, 3/155), and symptomatic and asymptomatic stroke in 21( 13.5%, 21/155), which resulted in 3 deaths ( 1.9%, 3/155). Cumulated disable stroke and death occurred in 9 patients ( 5.8%, 9/155). Cumulated neurological events, stroke, and disable stroke and death were 14.1% (20/142), 12.7%(18/142) and 4.9%, (7/142), respectively, in G1, compared with 30.8%( 4/13), 23.1%(3/13) and 15.展开更多
文摘Background and Purpose Annual stroke rates might be as high as 10% to 24% in patients with symptomatic intracranial stenosis on best medical therapy. Angioplasty with stent for symptomatic intracranial stenosis trial Ⅰ (ASSIST-Ⅰ) was a prospective and nonrandomized feasibility and safety study to evaluate the APOLLO Stent System for treatment of symptomatic intracranial artery stenosis, and prepare for ASSIST Ⅱ-a prospective, multicenter,and randomized controlled-study. The APOLLO stent delivery system (MicroPort Medical [Shanghai] Limited Co.), specifically designed for intracranial artery stenosis, consists of a stent and a balloon and a rapid-exchange delivery catheter. The stent is made of 316L stainless steel, with diameters of 2.0 to 4.0 mm and length of 8 mm or 13 mm. Only two links connect the rings of 1 mm in length, rendering the stent a good flexibility enough to navigate tortuous intracranial vessels. The nominated pressure of the stent is designed at 6 atm to reduce the risk of occlusion to side branches and perforators and rupture and dissection of target vessel. The crimping technique is applied in this system, insuring a compact ability of stent so wonderful that the struts of stent do not lift when the stent negotiates a turn, which lessen the likelihood of vessel wall injury and stent migrating. Materials and methods Thirty-four patients with 35 symptomatic intracranial stenoses of ≥50%, which resulted in transient ischemic attacks (TIAs [23 lesions /22 patients]) and minor stroke (7 lesions/7 patents), and both TIAs and stroke (5 lesions/ 5 patients), and with 1 asymptomatic severe stenosis, were enrolled in ASSIST-Ⅰ from December 10, 2003 to August 12, 2004. Their age was 54.3 years±SD of 9.49, three patients were male, and all had ≥1 risk factors of atherosclerosis. Patients received the evaluation of National Institutes of Health Stroke Scale (NIHSS), modified Rankin scale (mRS )and Barthel idex (BI) before and one-, three-, six-, and 12-month after the procedure. Results Stent success, defined as stent-assisted angioplasty successfully, resulting in ≤20% residual stenosis, was obtained in 35 lesions ( 97.2%, 35/36) and 33 patients ( 97.1%, 33/34). The stenosis rate of pre- and post -procedure was 80.5%± SD of 12.65 and 7.4%±SD 15.74, respectively. The Procedure-related complications were 8.3% for lesion (3/36) and 8.8% for patient (3/34), included 1 acute thrombosis, which obtained complete patency by means of intrathrombus thombolysis at once without sequelae, and 2 ischemic perforator strokes (1 irreversible stroke and 1 reversible). The disable stroke, defined as one that led to mRS score of ≥2, 30 days after the stroke, occurred in one patient ( 2.9%, 1/34; mRS of 2). Procedure success, defined as stent success without disable stroke or death at discharge by means of the endovascular therapy, was achieved in 33 lesions ( 91.7%, 33/36) and in 31 patients ( 91.2%, 31/34). Treatment success, defined as stent success without disable stroke and death at the 30th day, by means of the endovascular and medical therapy, was obtained in 34 lesions ( 94.4%, 34/36) and 32 patients ( 94.1%, 32/34). Clinical Follow-up, median 170 days (ranged from 30 days to 273 days; ≥1 month, n=34; ≥3 months, n=23; ≥6 months, n=13), was performed in 34 patients. There were no ischemic neurological events and death occurred. Cumulated disable stroke occurred in 1 patient ( 2.9%, 1/34). NIHSS was 1.09±SD of 1.694 and 0.47±SD of 1.051, before procedure and at the 30th day (n=34), respectively, and 0.57±SD of 0.992 at 3 months (n=23), 0.15±SD of 0.376 at 6 months (n=13), respectively; mRS was 0.65±SD of 0.812 and 0.47±SD of 0.563, before procedure and at 30 days, respectively, and 0.61±SD of 0.583 at 3 months, 0.38±SD of 0.506 at 6 months, respectively; and BI was 97.54±SD of 5.918 and 99.26±SD of 2.179, before procedure and at 30 days, respectively, and 99.35±SD of 2.288 at 3 months, 100.00±SD
文摘Background and Purpose Annual stroke rates might be as high as 10% to 24% in patients with symptomatic intracranial stenosis in spite of best medical therapy. This was a single center, nonrandomized prospective study to evaluate the safety, feasibility and clinical efficacy of stenting for patients with symptomatic intracranial stenosis. Methods One hundred and fifty-five consecutive patients with 170 symptomatic intracranial stenoses of ≥50%, resulted in transient ischemic attacks or minor stroke, were enrolled from September 5, 2001 to August 12, 2004. Their age was 50.9 years±SD of 12.98, 132 patients were male and 150 had ≥1 risk factors of atherosclerosis. The “offending” lesions were situated at middle cerebral (n=93), intracranial internal carotid (n=19), basilar (n=29), intracranial vertebral (n=28) and posterior inferior cerebellar (n=1). Patients received neurological evaluation with National Institutes of Health Stroke Scale (NIHSS) score before and immediately after procedure, and one-, three-, six-, and 12-month after the procedure. Disable stroke was defined as one that led to a modified Rankin scale (mRS) score of ≥2. 1. Results of the Periprocedural Period: Total of 177 balloon-expandable stents was used. Stent Success, defined as stent-assisted angioplasty successfully, resulting in ≤20% residual stenosis, was obtained in 157 lesions ( 92.4%, 157/170) and 142 patients ( 91.2%, 142/155). The stenosis rate of pre- and post -procedure for all patients was 78.2%±SD of 13.93 and 10.8%±SD 20.77, respectively The Procedure-related Complications were 11.8% for lesion (20/170) and 12.9% for patients (20/155), including 6 acute / subacute occlusions and 1 asymptomatic dissection, which all obtained complete patency by means of endovascular therapy at once without sequelae; 6 intracranial hemorrhage, 3 of them recovered (NIHSS at 30-day ≤pre-procedure’s) and one remained hemiparesis with 2 points on NIHSS score at the discharging time, and two died; 1 TIA , disappeared after 3 days; 1 reversible and 4 irreversible ischemic penetrator strokes, and1 irreversible embolic stroke . The rate of complications in stent success group (G1) was 13.4% (19/142) compared with 7.7% (1/13) in stent failure group (G2). The rates of disable stroke (n=5) and death (n=2) within 30 days were 4.5% (7/155) for total patients, 4.9% in G1 (7/142), and 0 in G 2(0/13), respectively. Endovascular Procedure Success was achieved in 144 lesions ( 84.7%, 144/170) and in 129 patients ( 83.2%, 129/155). Procedure success was defined as stent success without disable stroke or death at discharge by means of endovascular therapy, in spite of complications, such as acute / subacute occlusion or dissection. Treatment Success, defined as stent success without inability stroke and death at the 30 th day, by means of endovascular and medical therapy, was obtained in 150 lesions ( 88.2%, 150/170) and in 135 patients ( 87.1%, 135/155). 2. Results of Clinical and Angiographic Follow-up: Clinical Follow-up, median 344 days (ranged from 30 days to 1057 days, 378 days ± SD of 270.2), was performed in 150 patients (140 in G1 and 10 in G2). Ischemic neurological events in the distribution of the target lesion occurred in 5 patients ( 3.3%, 5/150), including 2 strokes and 1 death ( 2.0%, 3/150), and 2 TIAs ( 1.3%, 2/150) during the follow-up. Death and stroke ( 20.0%, 2/10), and TIAs ( 10.0%, 1 /10) in G2 were higher than that in G1 ( 0.7%, 1/140 and 0.7%, 1/140, respectively) after one month. Cumulated neurological events occurred in 15.5% (24/155) of total patients, included TIAs in 3( 1.9%, 3/155), and symptomatic and asymptomatic stroke in 21( 13.5%, 21/155), which resulted in 3 deaths ( 1.9%, 3/155). Cumulated disable stroke and death occurred in 9 patients ( 5.8%, 9/155). Cumulated neurological events, stroke, and disable stroke and death were 14.1% (20/142), 12.7%(18/142) and 4.9%, (7/142), respectively, in G1, compared with 30.8%( 4/13), 23.1%(3/13) and 15.
