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Klaus Amendt - One of the best experts on this subject based on the ideXlab platform.

  • Lesion Revascularisation Subsequent to Femoropopliteal Spot Stenting Using the Multi-LOC Stent Delivery System.
    in Vivo, 2019
    Co-Authors: Martin Sigl, Klaus Amendt, Matthias Waliszewski, Nils Rathmann
    Abstract:

    BACKGROUND/AIM: Restenosis and Stent fractures are well-characterised treatment failures following femoropopliteal (FP) Stent-based interventions. We aimed to determine patterns of restenosis and fracture rates following focal Stenting of FP arteries. PATIENTS AND METHODS: This retrospective study investigated angiographic patterns of restenosis and the occurrence of Stent fractures following focal FP Stenting with the multiple Stent Delivery System VascuFlex® Multi-LOC. RESULTS: We identified 10 patients with 10 (of 129) FP lesions (mean length 11.7±4.6 cm) and a total of 51 (of 646) Multi-LOC Stents that underwent clinically driven target lesion revascularizations (TLR) after 11.5±9.2 months, due to symptomatic recurrence of stenosis. None of the Multi-LOC Stents had fractured. No isolated in-Stent restenosis (>50%) was observed. Median diameter lumen loss was significantly more pronounced at the inter-Stent segments (27.0%) compared to in-Stent segments (7.8%, p=0.023). CONCLUSION: No evidence of fracture or susceptibility to Stent-related restenosis using Multi-LOC Stents was observed. Focal FP Stenting may be more effective when combined with strategies known to reduce restenosis in non-Stented artery segments.

  • Focal Stenting of Complex Femoropopliteal Lesions with the Multi-LOC Multiple Stent Delivery System: 12-Month Results of the Multicenter LOCOMOTIVE Study
    CardioVascular and Interventional Radiology, 2019
    Co-Authors: Martin Sigl, Matthias Waliszewski, Ulrich Beschorner, Ralf Langhoff, Thomas Zeller, Jörg Tautenhahn, Klaus Amendt
    Abstract:

    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 90.7% patency rate at 6 months in claudicants and critical limb ischemia patients. The 12-month outcomes of LOCOMOTIVE registry are presented in this report. ClinicalTrials.gov Identifier: NCT02531230. Methods The LOCOMOTIVE study (Multi- LOC for fl O w li M iting O utcomes after POBA and/or DCB T reatment in the infrainguinal position with the objec IVE to implant multiple Stent segments) investigates the efficacy and safety of the MSDS approach in an all-comers population. Clinical follow-ups at 6 and 12 months are scheduled to assess TLR, ABI, and vessel patency based on sonographic imaging. Results At 12 months, the primary unassisted patency was 85.7% and all-cause TLR rate was 9.3% in the overall cohort. Between baseline and 12 months, the target leg ABI increased from 0.62 ± 0.24 to 0.91 ± 0.38 ( p  

  • Multiple Stent Delivery System "Multi-LOC": Focal self-expanding nitinol Stenting of complex femoropopliteal lesions-A monocenter feasibility pilot study.
    JRSM cardiovascular disease, 2019
    Co-Authors: Martin Sigl, Johannes Jung, Heinz Kölble, Klaus Amendt
    Abstract:

    Aims: The Multiple Stent Delivery System (VascuFlex® Multi-LOC) is a novel Stent Delivery System with six short Stents (13 mm long each) mounted on one wire-guided catheter, designed for the treatment of femoropopliteal arteries. The aim of the present study is to evaluate the safety and the feasibility of the VascuFlex® "Multi-LOC" Stent Delivery System, which enables spot Stenting without changing the Delivery System. Methods and results: After proof of concept in a porcine model and after European Conformity marking, first clinical experiences were gathered in 20 patients with severe intermittent claudication or critical limb ischemia. First-in-human data are presented. The study included 20 limbs that underwent femoropopliteal revascularization for claudication (n = 14) or critical limb ischemia (n = 6). "Multi-LOC" provisional spot Stenting resulted in acute technical success in all lesions with resolution of flow-limiting dissection and elastic recoil after balloon dilatation of the femoropopliteal artery. There were no device-related complications. Follow-up examinations after 30 to 40 days revealed no major adverse events, and six months' results were encouraging. Conclusions: First clinical use of the novel Multiple Stent Delivery System (Multi-LOC) after balloon dilatation of the femoropopliteal artery was safe and feasible in this early study.

  • Focal Stenting of Complex Femoropopliteal Lesions with the Multi-LOC Multiple Stent Delivery System: 12-Month Results of the Multicenter LOCOMOTIVE Study.
    CardioVascular and Interventional Radiology, 2018
    Co-Authors: Martin Sigl, Matthias Waliszewski, Ulrich Beschorner, Ralf Langhoff, Thomas Zeller, Jörg Tautenhahn, Klaus Amendt
    Abstract:

    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 90.7% patency rate at 6 months in claudicants and critical limb ischemia patients. The 12-month outcomes of LOCOMOTIVE registry are presented in this report. ClinicalTrials.gov Identifier: NCT02531230. METHODS: The LOCOMOTIVE study (Multi-LOC for flOw liMiting Outcomes after POBA and/or DCB Treatment in the infrainguinal position with the objecIVE to implant multiple Stent segments) investigates the efficacy and safety of the MSDS approach in an all-comers population. Clinical follow-ups at 6 and 12 months are scheduled to assess TLR, ABI, and vessel patency based on sonographic imaging. RESULTS: At 12 months, the primary unassisted patency was 85.7% and all-cause TLR rate was 9.3% in the overall cohort. Between baseline and 12 months, the target leg ABI increased from 0.62 ± 0.24 to 0.91 ± 0.38 (p 

  • first clinical experience with the multi loc multiple Stent Delivery System for focal Stenting in long femoro popliteal lesions
    Vasa-european Journal of Vascular Medicine, 2017
    Co-Authors: Klaus Amendt, Martin Sigl, Matthias Waliszewski, Ulrich Beschorner, Ralf Langhoff, Jorg Thalwitzer, Ulf Redlich, Britta Vogel, D Hartel, Thomas Zeller
    Abstract:

    Abstract. Background: The purpose of this observational study is to report the six-month clinical outcomes with a new multiple Stent Delivery System in patients with femoro-popliteal lesions. Patients and methods: The LOCOMOTIVE study is an observational multicentre study with a primary endpoint target lesion revascularization (TLR) rate at six months. Femoro-popliteal lesions were prepared with uncoated and/or paclitaxel-coated peripheral balloon catheters. When flow limiting dissections, elastic recoil or recoil due to calcification required Stenting, up to six short Stents per Delivery device, each 13 mm in length, were implanted. Sonographic follow-ups and clinical assessments were scheduled at six months. Results: For this first analysis, a total of 75 patients 72.9 ± 9.2 years of age were enrolled. The majority of the 176 individually treated lesions were in the superficial femoral artery (76.2 %, 134/176) whereas the rate of TASC C/D amounted to 51.1 % (90/176). The total lesion length was 14...

Martin Sigl - One of the best experts on this subject based on the ideXlab platform.

  • Lesion Revascularisation Subsequent to Femoropopliteal Spot Stenting Using the Multi-LOC Stent Delivery System.
    in Vivo, 2019
    Co-Authors: Martin Sigl, Klaus Amendt, Matthias Waliszewski, Nils Rathmann
    Abstract:

    BACKGROUND/AIM: Restenosis and Stent fractures are well-characterised treatment failures following femoropopliteal (FP) Stent-based interventions. We aimed to determine patterns of restenosis and fracture rates following focal Stenting of FP arteries. PATIENTS AND METHODS: This retrospective study investigated angiographic patterns of restenosis and the occurrence of Stent fractures following focal FP Stenting with the multiple Stent Delivery System VascuFlex® Multi-LOC. RESULTS: We identified 10 patients with 10 (of 129) FP lesions (mean length 11.7±4.6 cm) and a total of 51 (of 646) Multi-LOC Stents that underwent clinically driven target lesion revascularizations (TLR) after 11.5±9.2 months, due to symptomatic recurrence of stenosis. None of the Multi-LOC Stents had fractured. No isolated in-Stent restenosis (>50%) was observed. Median diameter lumen loss was significantly more pronounced at the inter-Stent segments (27.0%) compared to in-Stent segments (7.8%, p=0.023). CONCLUSION: No evidence of fracture or susceptibility to Stent-related restenosis using Multi-LOC Stents was observed. Focal FP Stenting may be more effective when combined with strategies known to reduce restenosis in non-Stented artery segments.

  • Focal Stenting of Complex Femoropopliteal Lesions with the Multi-LOC Multiple Stent Delivery System: 12-Month Results of the Multicenter LOCOMOTIVE Study
    CardioVascular and Interventional Radiology, 2019
    Co-Authors: Martin Sigl, Matthias Waliszewski, Ulrich Beschorner, Ralf Langhoff, Thomas Zeller, Jörg Tautenhahn, Klaus Amendt
    Abstract:

    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 90.7% patency rate at 6 months in claudicants and critical limb ischemia patients. The 12-month outcomes of LOCOMOTIVE registry are presented in this report. ClinicalTrials.gov Identifier: NCT02531230. Methods The LOCOMOTIVE study (Multi- LOC for fl O w li M iting O utcomes after POBA and/or DCB T reatment in the infrainguinal position with the objec IVE to implant multiple Stent segments) investigates the efficacy and safety of the MSDS approach in an all-comers population. Clinical follow-ups at 6 and 12 months are scheduled to assess TLR, ABI, and vessel patency based on sonographic imaging. Results At 12 months, the primary unassisted patency was 85.7% and all-cause TLR rate was 9.3% in the overall cohort. Between baseline and 12 months, the target leg ABI increased from 0.62 ± 0.24 to 0.91 ± 0.38 ( p  

  • Multiple Stent Delivery System "Multi-LOC": Focal self-expanding nitinol Stenting of complex femoropopliteal lesions-A monocenter feasibility pilot study.
    JRSM cardiovascular disease, 2019
    Co-Authors: Martin Sigl, Johannes Jung, Heinz Kölble, Klaus Amendt
    Abstract:

    Aims: The Multiple Stent Delivery System (VascuFlex® Multi-LOC) is a novel Stent Delivery System with six short Stents (13 mm long each) mounted on one wire-guided catheter, designed for the treatment of femoropopliteal arteries. The aim of the present study is to evaluate the safety and the feasibility of the VascuFlex® "Multi-LOC" Stent Delivery System, which enables spot Stenting without changing the Delivery System. Methods and results: After proof of concept in a porcine model and after European Conformity marking, first clinical experiences were gathered in 20 patients with severe intermittent claudication or critical limb ischemia. First-in-human data are presented. The study included 20 limbs that underwent femoropopliteal revascularization for claudication (n = 14) or critical limb ischemia (n = 6). "Multi-LOC" provisional spot Stenting resulted in acute technical success in all lesions with resolution of flow-limiting dissection and elastic recoil after balloon dilatation of the femoropopliteal artery. There were no device-related complications. Follow-up examinations after 30 to 40 days revealed no major adverse events, and six months' results were encouraging. Conclusions: First clinical use of the novel Multiple Stent Delivery System (Multi-LOC) after balloon dilatation of the femoropopliteal artery was safe and feasible in this early study.

  • Focal Stenting of Complex Femoropopliteal Lesions with the Multi-LOC Multiple Stent Delivery System: 12-Month Results of the Multicenter LOCOMOTIVE Study.
    CardioVascular and Interventional Radiology, 2018
    Co-Authors: Martin Sigl, Matthias Waliszewski, Ulrich Beschorner, Ralf Langhoff, Thomas Zeller, Jörg Tautenhahn, Klaus Amendt
    Abstract:

    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 90.7% patency rate at 6 months in claudicants and critical limb ischemia patients. The 12-month outcomes of LOCOMOTIVE registry are presented in this report. ClinicalTrials.gov Identifier: NCT02531230. METHODS: The LOCOMOTIVE study (Multi-LOC for flOw liMiting Outcomes after POBA and/or DCB Treatment in the infrainguinal position with the objecIVE to implant multiple Stent segments) investigates the efficacy and safety of the MSDS approach in an all-comers population. Clinical follow-ups at 6 and 12 months are scheduled to assess TLR, ABI, and vessel patency based on sonographic imaging. RESULTS: At 12 months, the primary unassisted patency was 85.7% and all-cause TLR rate was 9.3% in the overall cohort. Between baseline and 12 months, the target leg ABI increased from 0.62 ± 0.24 to 0.91 ± 0.38 (p 

  • first clinical experience with the multi loc multiple Stent Delivery System for focal Stenting in long femoro popliteal lesions
    Vasa-european Journal of Vascular Medicine, 2017
    Co-Authors: Klaus Amendt, Martin Sigl, Matthias Waliszewski, Ulrich Beschorner, Ralf Langhoff, Jorg Thalwitzer, Ulf Redlich, Britta Vogel, D Hartel, Thomas Zeller
    Abstract:

    Abstract. Background: The purpose of this observational study is to report the six-month clinical outcomes with a new multiple Stent Delivery System in patients with femoro-popliteal lesions. Patients and methods: The LOCOMOTIVE study is an observational multicentre study with a primary endpoint target lesion revascularization (TLR) rate at six months. Femoro-popliteal lesions were prepared with uncoated and/or paclitaxel-coated peripheral balloon catheters. When flow limiting dissections, elastic recoil or recoil due to calcification required Stenting, up to six short Stents per Delivery device, each 13 mm in length, were implanted. Sonographic follow-ups and clinical assessments were scheduled at six months. Results: For this first analysis, a total of 75 patients 72.9 ± 9.2 years of age were enrolled. The majority of the 176 individually treated lesions were in the superficial femoral artery (76.2 %, 134/176) whereas the rate of TASC C/D amounted to 51.1 % (90/176). The total lesion length was 14...

Guido Costamagna - One of the best experts on this subject based on the ideXlab platform.

  • A novel gallbladder umbrella Stent (the Shai™ Stent) for prevention of stone migration and impaction: results on feasibility and short-term safety in a porcine model
    Surgical Endoscopy, 2019
    Co-Authors: Ivo Boskoski, Fred M. Konikoff, Shmuel Ben Muvhar, Jonathan Tsehori, Andrea Tringali, Guido Costamagna
    Abstract:

    Background and aims Cholelithiasis is the most common biliary tract disorder. Surgery is the treatment of choice for symptomatic gallstones. Aims of this study were to investigate the feasibility and short-term safety of a new endoscopic procedure with a specially designed Nitinol gallbladder Stent for blockage of gallstone migration, the Shai™ Stent. The Shai Stent is designed to enable free bile flow, which will be supposed to prevent recurrent attacks. Methods The Shai™ Stent was inserted into the gallbladder during a standard ERCP procedure using a conventional metal Stent Delivery System. The aim of the present study was to investigate the feasibility and safety of insertion and deployment and removal of the Stent into the gallbladder of pigs. In addition, the short-term safety of the Stent was evaluated. Results Fifteen Stents were placed in the gallbladder of 15 pigs. Mean procedure time was 25 min (15–37). The maximum follow-up before sacrifice was 42 days. The Stent in 1 pig had migrated at the 42 days follow-up but there were no macroscopic changes in its gallbladder or other organs. The Stent remained in place in the remaining 12 pigs at autopsy, and the gallbladder and bile ducts were macroscopically normal. Stent removal was easily done in two pigs immediately after placement. Conclusions Correct placement and removal of the Shai™ Stent in the gallbladder is safe and feasible in pigs. Further clinical trials are warranted to confirm these results and to effectively evaluate the capability of this Stent as an innovative biotechnology to block gallstones from migration and impaction.

  • A novel gallbladder umbrella Stent (the Shai™ Stent) for prevention of stone migration and impaction: results on feasibility and short-term safety in a porcine model
    Surgical Endoscopy and Other Interventional Techniques, 2019
    Co-Authors: Ivo Boskoski, Fred M. Konikoff, Shmuel Ben Muvhar, Jonathan Tsehori, Andrea Tringali, Guido Costamagna
    Abstract:

    Cholelithiasis is the most common biliary tract disorder. Surgery is the treatment of choice for symptomatic gallstones. Aims of this study were to investigate the feasibility and short-term safety of a new endoscopic procedure with a specially designed Nitinol gallbladder Stent for blockage of gallstone migration, the Shai™ Stent. The Shai Stent is designed to enable free bile flow, which will be supposed to prevent recurrent attacks. The Shai™ Stent was inserted into the gallbladder during a standard ERCP procedure using a conventional metal Stent Delivery System. The aim of the present study was to investigate the feasibility and safety of insertion and deployment and removal of the Stent into the gallbladder of pigs. In addition, the short-term safety of the Stent was evaluated. Fifteen Stents were placed in the gallbladder of 15 pigs. Mean procedure time was 25 min (15–37). The maximum follow-up before sacrifice was 42 days. The Stent in 1 pig had migrated at the 42 days follow-up but there were no macroscopic changes in its gallbladder or other organs. The Stent remained in place in the remaining 12 pigs at autopsy, and the gallbladder and bile ducts were macroscopically normal. Stent removal was easily done in two pigs immediately after placement. Correct placement and removal of the Shai™ Stent in the gallbladder is safe and feasible in pigs. Further clinical trials are warranted to confirm these results and to effectively evaluate the capability of this Stent as an innovative biotechnology to block gallstones from migration and impaction.

Ivo Boskoski - One of the best experts on this subject based on the ideXlab platform.

  • A novel gallbladder umbrella Stent (the Shai™ Stent) for prevention of stone migration and impaction: results on feasibility and short-term safety in a porcine model
    Surgical Endoscopy, 2019
    Co-Authors: Ivo Boskoski, Fred M. Konikoff, Shmuel Ben Muvhar, Jonathan Tsehori, Andrea Tringali, Guido Costamagna
    Abstract:

    Background and aims Cholelithiasis is the most common biliary tract disorder. Surgery is the treatment of choice for symptomatic gallstones. Aims of this study were to investigate the feasibility and short-term safety of a new endoscopic procedure with a specially designed Nitinol gallbladder Stent for blockage of gallstone migration, the Shai™ Stent. The Shai Stent is designed to enable free bile flow, which will be supposed to prevent recurrent attacks. Methods The Shai™ Stent was inserted into the gallbladder during a standard ERCP procedure using a conventional metal Stent Delivery System. The aim of the present study was to investigate the feasibility and safety of insertion and deployment and removal of the Stent into the gallbladder of pigs. In addition, the short-term safety of the Stent was evaluated. Results Fifteen Stents were placed in the gallbladder of 15 pigs. Mean procedure time was 25 min (15–37). The maximum follow-up before sacrifice was 42 days. The Stent in 1 pig had migrated at the 42 days follow-up but there were no macroscopic changes in its gallbladder or other organs. The Stent remained in place in the remaining 12 pigs at autopsy, and the gallbladder and bile ducts were macroscopically normal. Stent removal was easily done in two pigs immediately after placement. Conclusions Correct placement and removal of the Shai™ Stent in the gallbladder is safe and feasible in pigs. Further clinical trials are warranted to confirm these results and to effectively evaluate the capability of this Stent as an innovative biotechnology to block gallstones from migration and impaction.

  • A novel gallbladder umbrella Stent (the Shai™ Stent) for prevention of stone migration and impaction: results on feasibility and short-term safety in a porcine model
    Surgical Endoscopy and Other Interventional Techniques, 2019
    Co-Authors: Ivo Boskoski, Fred M. Konikoff, Shmuel Ben Muvhar, Jonathan Tsehori, Andrea Tringali, Guido Costamagna
    Abstract:

    Cholelithiasis is the most common biliary tract disorder. Surgery is the treatment of choice for symptomatic gallstones. Aims of this study were to investigate the feasibility and short-term safety of a new endoscopic procedure with a specially designed Nitinol gallbladder Stent for blockage of gallstone migration, the Shai™ Stent. The Shai Stent is designed to enable free bile flow, which will be supposed to prevent recurrent attacks. The Shai™ Stent was inserted into the gallbladder during a standard ERCP procedure using a conventional metal Stent Delivery System. The aim of the present study was to investigate the feasibility and safety of insertion and deployment and removal of the Stent into the gallbladder of pigs. In addition, the short-term safety of the Stent was evaluated. Fifteen Stents were placed in the gallbladder of 15 pigs. Mean procedure time was 25 min (15–37). The maximum follow-up before sacrifice was 42 days. The Stent in 1 pig had migrated at the 42 days follow-up but there were no macroscopic changes in its gallbladder or other organs. The Stent remained in place in the remaining 12 pigs at autopsy, and the gallbladder and bile ducts were macroscopically normal. Stent removal was easily done in two pigs immediately after placement. Correct placement and removal of the Shai™ Stent in the gallbladder is safe and feasible in pigs. Further clinical trials are warranted to confirm these results and to effectively evaluate the capability of this Stent as an innovative biotechnology to block gallstones from migration and impaction.

Mauro Moscucci - One of the best experts on this subject based on the ideXlab platform.

  • Facilitated advancement of the Palmaz-Schatz Stent Delivery System with the use of an adjacent 0.018′ stiff wire
    Catheterization and Cardiovascular Diagnosis, 1996
    Co-Authors: Jorge F. Saucedo, David W.m. Muller, Mauro Moscucci
    Abstract:

    A 58-yr-old man, status postcoronary artery bypass surgery (CABG) in 1990 with a left internal mammary artery (LIMA) graft and three saphenous vein grafts (SVG), was admitted with a 1-yr history of stable angina. A stress thallium test showed a large, reversible lateral defect. Selective coronary angiography showed that the proximal left anterior descending coronary artery (LAD) was totally occluded. The left circumflex (LCX) had a complex, eccentric 90% stenosis in the proximal third, and a complex, ulcerated, long 90% stenosis in midthird (Fig. IA). The right coronary artery (RCA) was diffusely diseased and had a 70% stenosis in its distal third before its bifurcation. The SVGs to the obtuse marginal (OM) and to the RCA were both occluded. An SVG to the native LAD was patent, but the LIMA to the LAD was occluded in its distal third. A PTCA of both

  • facilitated advancement of the palmaz schatz Stent Delivery System with the use of an adjacent 0 018 stiff wire
    Catheterization and Cardiovascular Diagnosis, 1996
    Co-Authors: Jorge F. Saucedo, David W.m. Muller, Mauro Moscucci
    Abstract:

    A 58-yr-old man, status postcoronary artery bypass surgery (CABG) in 1990 with a left internal mammary artery (LIMA) graft and three saphenous vein grafts (SVG), was admitted with a 1-yr history of stable angina. A stress thallium test showed a large, reversible lateral defect. Selective coronary angiography showed that the proximal left anterior descending coronary artery (LAD) was totally occluded. The left circumflex (LCX) had a complex, eccentric 90% stenosis in the proximal third, and a complex, ulcerated, long 90% stenosis in midthird (Fig. IA). The right coronary artery (RCA) was diffusely diseased and had a 70% stenosis in its distal third before its bifurcation. The SVGs to the obtuse marginal (OM) and to the RCA were both occluded. An SVG to the native LAD was patent, but the LIMA to the LAD was occluded in its distal third. A PTCA of both