Background: The safety and efficacy of carotid artery stenting (CAS) can be affected by certain technical and anatomical factors. However, it is not known whether the use of a dual-layer micromesh stent (DLMS) with a low-crossing profile could reduce the risks associated with complex vascular anatomies during CAS.
Methods: This study involved 1965 asymptomatic or symptomatic carotid artery stenosis patients who received the Roadsaver DLMS during CAS, as part of a prospective, multicenter observational ROADSAVER study, conducted from January 2018 to February 2021.
Background: In contemporary clinical practice, carotid artery stenting (CAS) is increasingly becoming a multispecialty field, joining operators of various training backgrounds, which bring forth their unique expertise, patient management philosophies, and procedural preferences. The best practices and approaches, however, are still debated. Therefore, real-world insights on different operator preferences and related outcomes are of utmost value, yet still rather scarce in the available literature.
View Article and Find Full Text PDFWe investigated the safety and efficacy of debulking infrainguinal lesions in patients with peripheral artery disease (PAD) undergoing endovascular revascularization (EVR) as part of the RECording Courses of vascular Diseases (RECCORD) registry. Patient and lesion specific characteristics, including the lesion complexity score (LCS) were analyzed. The primary endpoint encompassed: (i) clinical improvement in Rutherford categories, (ii) index limb re-interventions, and (iii) major amputations during follow-up.
View Article and Find Full Text PDFThe quality of vascular care has significantly improved in part by the expansion of endovascular techniques for the treatment of symptomatic peripheral artery disease (PAD) in recent years. In Germany these are primarily provided by the three disciplines of vascular surgery, angiology, and interventional radiology (IR). However, the relative contribute of angiologists to the total number of cases performed is unknown.
View Article and Find Full Text PDFEndovascular arterial revascularisations for the treatment of symptomatic peripheral arterial disease are constantly increasing in importance and number due to the changing age structure and high numbers of comorbidities in the German population. Patients with peripheral artery disease are often at increased risk for peri- and post-procedural complications including severe cardiovascular events. Due to limited financial and human resources and considerable risks of hospitalization, endovascular interventions that were previously reserved for hospitalized patients are now progressively considered to be performed as day case procedures.
View Article and Find Full Text PDFTogether with colleagues from different disciplines, including cardiologists, interventional radiologists and vascular surgeons, committee members of the of the German Society of Angiology ( []), developed a novel algorithm for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs). Our aim is to improve patient and limb related outcomes, by increasing the success rate of endovascular procedures. This can be achieved by adherence to the proposed crossing algorithm, aiding the standardization of endovascular procedures.
View Article and Find Full Text PDFA crossing algorithm was developed for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs) to educate, guide, and appropriately influence clinical practice aiming at harmonization and standardization of endovascular procedures. The following steps are proposed: One, duplex sonography and if required computed tomography or magnetic resonance angiography for the selection of the optimal access site. Two, angiographic evaluation of the proximal/distal cap morphology, presence of collaterals at the origin of the proximal cap and at the distal vessel refilling site.
View Article and Find Full Text PDFMany patients with peripheral arterial disease (PAD) exhibit undiagnosed obstructive coronary artery disease. We aim to identify the patients with lifestyle limiting claudication due to PAD and without cardiac symptoms, requiring coronary revascularization based on high-sensitive troponin T (hsTnT) values. We assessed hsTnT in consecutive patients referred for elective endovascular treatment due to claudication [Rutherford categories (RC) 2 & 3] between January 2018 and December 2021.
View Article and Find Full Text PDFBackground: So far only 1-year data have been reported for direct comparisons of paclitaxel-coated balloons (PCBs) using different coating technologies.
Objectives: The aim of this study was to report the 24-month results on the efficacy and safety of low-dose vs high-dose PCBs with nominal paclitaxel densities of 2.0 and 3.
Catheter Cardiovasc Interv
November 2022
Objectives: The PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis.
Background: The risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting.
Methods: In total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe.
This study investigated the distribution of risk factors, lesion characteristics and endovascular revascularization (EVR) strategies in patients with peripheral arterial disease (PAD) with vs without diabetes mellitus (DM). Data were collected within the RECcording COurses of vasculaR Diseases (RECCORD) registry. Demographic data, lesion localization (iliac vs femoropopliteal vs below-the-knee (BTK)) and lesion complexity score (LCS) based on number of affected segments, and lesion length (< 10 vs 10-20 vs > 20 cm), EVR strategies and peri-procedural complications were analysed in 786 patients with and 1337 without diabetes mellitus.
View Article and Find Full Text PDFObjectives: The aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics.
Background: DES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating.
Purpose: Endovascular carotid artery stenosis treatment is associated with a higher peri- and early post-procedural stroke risk relative to surgery. Dual-layer micromesh carotid stents were specifically designed for improved plaque coverage to reduce the cerebral embolization risk and related ischemic events. ROADSAVER study aims to further confirm the safety and efficacy of the Roadsaver™ dual-layer micromesh stent for the treatment of elective patients with carotid artery stenosis.
View Article and Find Full Text PDFWe evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate.
View Article and Find Full Text PDFBackground: Patients with peripheral arterial occlusive disease (PAOD) are at ele - vated risk for cardiovascular events and vascular events affecting the limbs. The goals of antithrombotic treatment are to keep vessels open after revascularization, to prevent cardiovascular events, and to lessen the frequency of peripheral ischemia and of amputation.
Methods: This review is based on pertinent publications retrieved by a selective literature search, with particular attention to meta-analyses, randomized controlled trials, and the German and European angiological guidelines.
: This study aimed to evaluate a Multiple Stent Delivery System for provisional focal stenting of the femoropopliteal artery. : The LOCOMOTIVE EXTENDED study (Multi- for flw liiting utcomes after plain old balloon angioplasty and/or drug-coated balloon reatment in the infrainguinal position with the object to implant multiple stent segments) is a prospective, single-arm, multicentre observational study. The Multi-LOC Multiple Stent Delivery System (B.
View Article and Find Full Text PDFSystemic antineoplastic treatment agents represent one of the fastest developing medical fields. Oncological treatment is becoming increasingly individualized and new targets with corresponding agents, are constantly being developed. In tandem with this progress, new combinations and algorithms have evolved and patient's outcome have improved.
View Article and Find Full Text PDFThe RECcording COurses of vasculaR Diseases (RECCORD) registry established by the German Society of Angiology - Society for Vascular Medicine aimed to address the lack in contemporary real-world data regarding current practice of medical and interventional care in vascular patients. We herein report the demographic and procedural characteristics of the first 1000 patients undergoing endovascular revascularization (EVR) for symptomatic peripheral artery disease (PAD). RECCORD is an observational, prospective, multicenter, all-comers registry.
View Article and Find Full Text PDFAims: Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact™) vs.
View Article and Find Full Text PDFDtsch Med Wochenschr
October 2019
Dual antithrombotic therapy (DAT) with low-dose rivaroxaban in combination with acetylsalicylic acid (ASA) is available to patients with stable atherosclerotic disease as a new therapeutic option.The results of the COMPASS trial demonstrate a significant relative risk reduction of cardiovascular outcomes by 24 % with low-dose DAT in patients with stable peripheral arterial disease or coronary heart disease.Despite a guideline adherent secondary prevention therapy, the cardiovascular event rate with ASA alone during the mean study period of almost two years was 5.
View Article and Find Full Text PDFObjectives: This study evaluated the safety and performance of the Paladin System, a novel angioplasty balloon with an integrated embolic protection filter designed to increase embolic protection during post-dilation.
Background: The risk of major adverse events during carotid artery stenting (CAS) is equivalent to carotid endarterectomy. However, the risk of minor stroke remains higher with CAS.
Introduction: The purpose of this observational study is to report the 12-month clinical outcomes with the novel Multiple Stent Delivery System (MSDS) to treat complex femoropopliteal lesions. Previously, we reported the 6-month clinical outcomes of the all-comers LOCOMOTIVE study, which demonstrated the safety and efficacy of the MSDS with a favorable target lesion revascularization (TLR) rate of 5.3% and a 90.
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