Abstract:
OBJECTIVE:This report presents the 30-day results of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial and evaluates the safety and efficacy of ENROUTE Transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif), a novel transcarotid neuroprotection system that provides direct surgical common carotid access and cerebral embolic protection via high-rate flow reversal during carotid artery stenting (CAS). METHODS:A prospective, single-arm, multicenter clinical trial was performed to evaluate the use of the ENROUTE Transcarotid NPS during CAS procedures performed in patients considered to be at high risk for complications from carotid endarterectomy. Symptomatic patients with ≥50% stenosis and asymptomatic patients with ≥70% stenosis were eligible to be treated with any U.S. Food and Drug Administration-approved carotid artery stent. The primary end point was the composite of all stroke, myocardial infarction (MI), and death at 30 days postprocedure as defined in the Food and Drug Administration-approved study protocol. Secondary end points included cranial nerve injury; 30-day stroke, death, stroke/death, and MI; acute device, technical, and procedural success; and access site complications. All major adverse events were adjudicated by an independent clinical events committee. RESULTS:Between November 2012 and July 2014, 208 patients were enrolled at 18 sites. Sixty-seven patients were enrolled as lead-in cases, and 141 were enrolled in the pivotal phase. In the pivotal cohort, 26% were symptomatic and 75% were asymptomatic. Acute device and technical success were 99% (140 of 141). By hierarchical analysis, the all-stroke rate in the pivotal group was 1.4% (2 of 141), stroke and death was 2.8% (4 of 141), and stroke, death and MI was 3.5% (5 of 141). One patient (0.7%) experienced postoperative hoarseness from potential Xth cranial nerve injury, which completely resolved at the 6-month follow-up visit. CONCLUSIONS:The results of the ROADSTER trial demonstrate that the use of the ENROUTE Transcarotid NPS is safe and effective at preventing stroke during CAS. The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of CAS.
journal_name
J Vasc Surgjournal_title
Journal of vascular surgeryauthors
Kwolek CJ,Jaff MR,Leal JI,Hopkins LN,Shah RM,Hanover TM,Macdonald S,Cambria RPdoi
10.1016/j.jvs.2015.04.460subject
Has Abstractpub_date
2015-11-01 00:00:00pages
1227-34issue
5eissn
0741-5214issn
1097-6809pii
S0741-5214(15)01147-7journal_volume
62pub_type
临床试验,杂志文章,多中心研究abstract:OBJECTIVE:Pre-emptive selective embolization of inferior mesenteric artery (IMA), lumbar arteries (LAs), and perigraft sac for prevention of type II endoleak (T2EL) has not been widely adopted. We perform pre-emptive nonselective perigraft aortic sac embolization with coils (PNPASEC) in patients at high risk for develo...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2018.10.054
更新日期:2019-06-01 00:00:00
abstract::This study evaluated the role of duplex scanning in the management of patients with normal or minimally diseases carotid arteries. Carotid duplex scans were interpreted according to previously established criteria and considered normal when pulsed Doppler spectral waveforms showed laminar flow or only minor flow distu...
journal_title:Journal of vascular surgery
pub_type: 临床试验,杂志文章
doi:
更新日期:1990-10-01 00:00:00
abstract::Endovascular techniques with coil embolization have been used in certain visceral aneurysm cases, often resulting in sacrifice of the involved visceral vessel and end-organ thrombosis. We describe two cases in which stent grafts were used to treat these aneurysms, allowing preservation of visceral artery and end-organ...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1067/mva.2002.129645
更新日期:2002-12-01 00:00:00
abstract:OBJECTIVE:This review describes the clinical outcome of surgical intervention for atherosclerotic renovascular disease in 500 consecutive patients with hypertension. METHODS:From January 1987 to December 1999, 626 patients underwent operative renal artery (RA) repair at our center. A subgroup of 500 patients (254 wome...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1067/mva.2002.120376
更新日期:2002-02-01 00:00:00
abstract:OBJECTIVE:Multiple studies have established that patch angioplasty following carotid endarterectomy (CEA) reduces the risk of subsequent stroke and restenosis compared with primary closure. Previous reports have also demonstrated bovine pericardium to be associated with similar rates of postoperative complications and ...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2011.10.007
更新日期:2012-03-01 00:00:00
abstract::Type B aortic dissections continue to be one of the most challenging clinical scenarios confronting vascular surgeons. In the era of open surgery, the therapeutic options were limited to medical management of hypertension and large open thoracoabdominal operations. In the current endovascular era, the operative strate...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2013.06.023
更新日期:2013-09-01 00:00:00
abstract:OBJECTIVE AND METHOD:In this retrospective review, we report the surgical results of infected aortic aneurysms treated at a single center over 5 years. RESULTS:From October 1996 to October 2001, 19 patients with infected aortic aneurysm were treated with surgery, nine with suprarenal infections (four proximal descendi...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1067/mva.2002.126557
更新日期:2002-10-01 00:00:00
abstract:OBJECTIVE:The objective of this study was to determine whether calf muscle hemoglobin oxygen saturation (Sto2) obtained during a standardized treadmill test is associated with ambulatory function and health-related quality of life (HRQoL) in patients with symptomatic peripheral artery disease (PAD). We hypothesized tha...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2019.09.057
更新日期:2020-08-01 00:00:00
abstract:BACKGROUND:Ilio-caval stenting now represents the first line treatment for disabling obstructive ilio-caval lesions. Most patients are young women of child-bearing age. We herein report our experience of pregnancy in women who have a history of ilio-caval stenting. MATERIALS AND METHODS:From November 1995 to April 200...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2009.01.034
更新日期:2009-08-01 00:00:00
abstract:BACKGROUND:Lipid-modifying drug therapy (LMDT) is recommended in all patients having coronary or noncoronary atherosclerotic disease. However, the effect of LMDT after abdominal aortic aneurysm (AAA) repair, especially in the absence of other atherosclerotic manifestations, is unclear. We examined the distribution of p...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2013.01.036
更新日期:2013-08-01 00:00:00
abstract:OBJECTIVES:The purpose of this study was to review our experience with delayed open conversion (>30 days) following endovascular aortoiliac aneurysm repair (EVAR) and to introduce the concept and advantages of endograft retention in this setting. METHODS:From January 1992 to January 2003, a total of 386 EVARs using a ...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2003.09.012
更新日期:2003-12-01 00:00:00
abstract:OBJECTIVE:Intimal hyperplasia is a major obstacle to patency in grafted veins. Although migration and proliferation of vascular smooth muscle cells (SMCs) pivotally affect the vascular remodeling process, no therapy has been established to prevent intimal hyperplasia of vein grafts. We previously reported that the acti...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2013.06.080
更新日期:2014-08-01 00:00:00
abstract::We report the case of a 78-year-old man with coronary artery disease, chronic obstructive pulmonary disease, and chronic renal insufficiency with an enlarging 6.7-cm infrarenal abdominal aortic aneurysm. He also had a 4-cm right common iliac artery aneurysm, and right external iliac artery occlusion. The patient had a...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2013.05.105
更新日期:2014-06-01 00:00:00
abstract::Distal internal carotid artery exposure can be technically demanding even for experienced vascular surgeons. Although a variety of techniques have been described to facilitate such exposure, temporary mandibular subluxation has emerged as the simplest and least debilitating approach. Current techniques for maintaining...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:
更新日期:1990-09-01 00:00:00
abstract:OBJECTIVE:Surgical treatment of arterial lesions associated with Behçet disease (BD) is often complicated by graft occlusion and recurrence of aneurysms. The purpose of this study was to clarify the long-term outcome of surgical intervention for arterial involvement in BD. METHODS:Ten patients with BD (9 men, 1 woman)...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2005.03.019
更新日期:2005-07-01 00:00:00
abstract:OBJECTIVE:The addition of skin perfusion pressure (SPP) might enhance the predictive value of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system. The purpose of the present study was to evaluate the SPP for each WIfI classification stage among patients with foot wounds by ...
journal_title:Journal of vascular surgery
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jvs.2019.01.045
更新日期:2019-10-01 00:00:00
abstract:BACKGROUND:Outcomes of revascularization for critical limb ischemia (CLI) have historically been patency, limb salvage, and survival. Functional status and quality of life have not been well described. This study used functional and quality of life assessments to measure patient-centered outcomes after revascularizatio...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2014.01.067
更新日期:2014-07-01 00:00:00
abstract::Chronic wounds such as venous stasis ulcers have become a socioeconomic problem. Even with successful initial management, the recurrence rate approaches 70%. With the advent of new wound healing agents, nonoperative attempts to heal these wounds appear indicated. This study reports a prospective randomized evaluator-b...
journal_title:Journal of vascular surgery
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1067/mva.1992.37086
更新日期:1992-08-01 00:00:00
abstract::We performed a total laparoscopic reimplantation of the inferior mesenteric artery (IMA) during laparoscopic infrarenal aortic aneurysm repair. The postoperative course was uneventful, and angiograms showed a patent IMA after reimplantation. To our knowledge, total laparoscopic reimplantation of the IMA in human being...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2004.01.015
更新日期:2004-05-01 00:00:00
abstract::Two hundred seventy-one of 1509 patients who underwent thoracoabdominal aortic repairs had either celiac or superior mesenteric or renal artery occlusive disease. These latter patients were treated by endarterectomy or bypass between June 20, 1960 and Jan. 10, 1991. After 1987, the 30-day survival rate was 93% (79 of ...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:
更新日期:1992-09-01 00:00:00
abstract::We report seven cases of dissection of the abdominal aorta. Three patients had acute back pain, whereas four patients had more chronic courses. In six cases, as a result of the palpation of a pulsatile abdominal mass, clinical diagnosis was an atheromatous aneurysm. Angiography and CT scanning demonstrated a dissected...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:
更新日期:1990-03-01 00:00:00
abstract:PURPOSE:The purpose of this study was to determine factors that may influence patient selection for surgery in recurrent carotid stenosis (RCS) and to contrast the results of primary and secondary carotid endarterectomy (CENDX) with regard to operative morbidity and stroke prevention. METHODS:Forty-eight patients who ...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/s0741-5214(96)70095-2
更新日期:1996-08-01 00:00:00
abstract:PURPOSE:The purpose of this study was to present the use of superficial femoral vein (SFV) as an arterial bypass graft when ipsilateral saphenous vein is inadequate. METHODS:Data collected prospectively were reviewed on 24 patients (25 limbs) who had an arterial bypass with SFV performed by the authors between January...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/0741-5214(94)90232-1
更新日期:1994-12-01 00:00:00
abstract::Large veins (superior and inferior vena cava, portal vein) have been replaced successfully with lower extremity deep veins (superficial femoral-popliteal). Femoropopliteal bypass with superficial femoral-popliteal veins has been reported to give excellent long-term results. Nevertheless, this source of autogenous vein...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1067/mva.1991.31965
更新日期:1991-11-01 00:00:00
abstract:PURPOSE:To evaluate the prevalence, factors, and clinical impact of self-expanding stent fracture following iliac artery stenting. MATERIALS AND METHODS:A review of the endovascular registry database for our department showed 353 patients with occlusive diseases of the iliac artery who underwent stenting between 1997 ...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2008.10.019
更新日期:2009-03-01 00:00:00
abstract::Preferred treatment for thromboembolism when heparin fails or is contraindicated is infrarenal inferior vena cava (IVC) interruption. In the present study suprarenal Greenfield filters were placed in 11 patients in whom routine infrarenal IVC interruption would have been inadequate therapy. As identified by IVC venogr...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:
更新日期:1984-01-01 00:00:00
abstract:INTRODUCTION:Endovascular therapy (percutaneous transluminal angioplasty [PTA] with stenting) has been increasingly applied in patients with chronic mesenteric ischemia (CMI) to avoid morbidities associated with open repair (OR). The purpose of this study was to compare outcomes of PTA/Stent vs OR in patients with symp...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2007.01.067
更新日期:2007-06-01 00:00:00
abstract:BACKGROUND:Long-term results of the posterior approach (PA) for the treatment of popliteal artery aneurysms are lacking in the literature. We reviewed our experience during a 13-year period in patients with popliteal artery aneurysms, comparing those treated through a PA with those operated on through a standard medial...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1016/j.jvs.2015.06.227
更新日期:2015-12-01 00:00:00
abstract::Effort thrombosis of the subclavian vein (Paget-Schroetter syndrome) has long been considered a primary thrombotic process, but recent experience suggests that it may commonly result from repeated mechanical compression. Increased awareness of the pathophysiology of this syndrome can allow timely, improved diagnostic ...
journal_title:Journal of vascular surgery
pub_type: 杂志文章
doi:10.1067/mva.1992.41523
更新日期:1992-11-01 00:00:00
abstract:PURPOSE:Although the United Kingdom small aneurysm trial reported no survival benefit for early operation in patients with small (4. 0-5.5 cm) abdominal aortic aneurysms (AAAs), the trial lacked statistical power to detect small but potentially meaningful gains in life expectancy, particularly for specific subgroups. W...
journal_title:Journal of vascular surgery
pub_type: 临床试验,杂志文章
doi:10.1016/s0741-5214(00)90152-6
更新日期:2000-02-01 00:00:00