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J. De Schepper - One of the best experts on this subject based on the ideXlab platform.

  • clinical and angiographic outcomes following first in man implantation of a novel thin strut low profile fixed wire stent the svelte coronary stent Integrated Delivery System first in man trial
    Eurointervention, 2013
    Co-Authors: Roberto Diletti, Hector M Garciagarcia, Richard Spencer, Pierfrancesco Agostoni, Vasim Farooq, Christos V Bourantas, Takashi Muramatsu, Robert Jan Van Geuns, Nicolas M Van Mieghem, J. De Schepper
    Abstract:

    AIMS: The Svelte Stent Integrated Delivery System (IDS) is a novel fixed-wire thin-strut cobalt-chromium stent characterised by a very low entry profile. The aim of the present study is to evaluate the safety and the feasibility of the Svelte stent IDS implantation in humans. METHODS AND RESULTS: The present investigation is a prospective, multicentre non-randomised single-arm study. The primary endpoint was freedom from major adverse cardiac events (MACE) at 30 days post-procedure. Invasive follow-up was scheduled at six months post implantation. A total of 47 patients were enrolled and serial OCT imaging was performed in a subgroup of 18 patients. At the index procedure the lesion success rate was 97.9% (46 patients), the mean acute gain was 1.56 ± 0.43 mm with a mean minimum lumen diameter of 2.48 ± 0.43 mm. Post-implantation OCT imaging revealed a minimal mean prolapse area (0.10 ± 0.06 mm²), mean incomplete stent apposition area (0.12 ± 0.13 mm²) and mean intraluminal mass area (0.05 ± 0.03 mm²). Edge dissections were reported in eight cases (mean dissection width 0.17 ± 0.07 mm proximally and 0.25 ± 0.24 mm distally). At 30-day clinical follow-up, one case of myocardial infarction was reported. At six months, the angiographic mean in-stent late loss was 0.95 ± 0.76 mm. By OCT, a high percentage of struts was covered (97.6 ± 15.00 %) with a mean neointimal thickness of 0.31 ± 0.14 mm, all edge dissections were clinically silent and healed. Target lesion revascularisation (TLR) occurred in 11 patients (23.4%) and clinically driven TLR in three of these patients (6.4%). No cases of death or stent thrombosis were reported during the study. CONCLUSIONS: Implantation of the Svelte stent IDS was observed to be safe, feasible and associated with a low acute vascular injury and a high percentage of strut coverage at 6-month follow-up.

  • clinical and angiographic outcomes following first in man implantation of a novel thin strut low profile fixed wire stent the svelte coronary stent Integrated Delivery System first in man trial
    Eurointervention, 2013
    Co-Authors: Roberto Diletti, Robert Jan Van Geuns, Nicolas M Van Mieghem, Hector M Garciagarcia, Richard Spencer, Pierfrancesco Agostoni, Vasim Farooq, Christos V Bourantas, Takashi Muramatsu, J. De Schepper
    Abstract:

    textabstractAims: The Svelte Stent Integrated Delivery System (IDS) is a novel fixed-wire thin-strut cobalt-chromium stent characterised by a very low entry profile. The aim of the present study is to evaluate the safety and the feasibility of the Svelte stent IDS implantation in humans. Methods and results: The present investigation is a prospective, multicentre non-randomised single-arm study. The primary endpoint was freedom from major adverse cardiac events (MACE) at 30 days post-procedure. Invasive follow-up was scheduled at six months post implantation. A total of 47 patients were enrolled and serial OCT imaging was performed in a subgroup of 18 patients. At the index procedure the lesion success rate was 97.9% (46 patients), the mean acute gain was 1.56±0.43 mm with a mean minimum lumen diameter of 2.48±0.43 mm. Post-implantation OCT imaging revealed a minimal mean prolapse area (0.10±0.06 mm2), mean incomplete stent apposition area (0.12±0.13 mm2) and mean intraluminal mass area (0.05±0.03 mm2). Edge dissections were reported in eight cases (mean dissection width 0.17±0.07 mm proximally and 0.25±0.24 mm distally). At 30-day clinical follow-up, one case of myocardial infarction was reported. At six months, the angiographic mean in-stent late loss was 0.95±0.76 mm. By OCT, a high percentage of struts was covered (97.6 ±15.00%) with a mean neointimal thickness of 0.31±0.14 mm, all edge dissections were clinically silent and healed. Target lesion revascularisation (TLR) occurred in 11 patients (23.4%) and clinically driven TLR in three of these patients (6.4%). No cases of death or stent thrombosis were reported during the study. Conclusions: Implantation of the Svelte stent IDS was observed to be safe, feasible and associated with a low acute vascular injury and a high percentage of strut coverage at 6-month follow-up.

Stefan Verheye - One of the best experts on this subject based on the ideXlab platform.

Pierfrancesco Agostoni - One of the best experts on this subject based on the ideXlab platform.

  • svelte Integrated Delivery System performance examined through diagnostic catheter Delivery the speed registry
    Catheterization and Cardiovascular Interventions, 2015
    Co-Authors: Ahmed Anower Khattab, Freek Nijhoff, Steffen Brucks, Fabian Nietlispach, Joachim Schofer, Julien Berland, Pierfrancesco Agostoni, Bernhard Meier, Pieter R. Stella
    Abstract:

    Aims The multi-center SPEED registry evaluated the procedural success and in-hospital clinical outcomes of direct stenting with the Svelte ‘all-in-one’ coronary stent Integrated Delivery System (IDS) through diagnostic catheters to identify the clinical indications for which this approach is appropriately suited. Methods & results Forty-eight (48) patients with 54 lesions of lengths ≤20 mm and RVD 2.5–3.5 mm were targeted for direct stenting through diagnostic catheters (4–6F) via radial or femoral approach. Procedural characteristics early in an investigator's experience (28 lesions) were compared with outcomes following experience (26 lesions). Procedure, device and strategy success were realized in 54 (100%), 50 (93%) and 46 (85%) lesions, respectively, with strategy success significantly related to RVD (P = 0.05), lesion location (P = 0.01), and diagnostic catheter size (P = 0.05). Significant improvement in crossing and intervention time and trends toward improvement in device and strategy success, reductions in procedure and radiation time and contrast use were observed. Conclusions Direct stenting through diagnostic catheters via radial or femoral approach using the Svelte IDS is feasible and associated with good in-hospital outcomes. This approach offers the attractive option of assessing lesions via diagnostic catheter and, depending upon vessel anatomy and lesion morphology, continuing with ad-hoc interventional treatment using the same diagnostic catheter. Improvements in strategy success and procedural efficiencies, based on operator experience, facilitate catheter downsizing and reduce intervention time, ancillary product use and overall procedure costs. © 2014 Wiley Periodicals, Inc.

  • clinical and angiographic outcomes following first in man implantation of a novel thin strut low profile fixed wire stent the svelte coronary stent Integrated Delivery System first in man trial
    Eurointervention, 2013
    Co-Authors: Roberto Diletti, Hector M Garciagarcia, Richard Spencer, Pierfrancesco Agostoni, Vasim Farooq, Christos V Bourantas, Takashi Muramatsu, Robert Jan Van Geuns, Nicolas M Van Mieghem, J. De Schepper
    Abstract:

    AIMS: The Svelte Stent Integrated Delivery System (IDS) is a novel fixed-wire thin-strut cobalt-chromium stent characterised by a very low entry profile. The aim of the present study is to evaluate the safety and the feasibility of the Svelte stent IDS implantation in humans. METHODS AND RESULTS: The present investigation is a prospective, multicentre non-randomised single-arm study. The primary endpoint was freedom from major adverse cardiac events (MACE) at 30 days post-procedure. Invasive follow-up was scheduled at six months post implantation. A total of 47 patients were enrolled and serial OCT imaging was performed in a subgroup of 18 patients. At the index procedure the lesion success rate was 97.9% (46 patients), the mean acute gain was 1.56 ± 0.43 mm with a mean minimum lumen diameter of 2.48 ± 0.43 mm. Post-implantation OCT imaging revealed a minimal mean prolapse area (0.10 ± 0.06 mm²), mean incomplete stent apposition area (0.12 ± 0.13 mm²) and mean intraluminal mass area (0.05 ± 0.03 mm²). Edge dissections were reported in eight cases (mean dissection width 0.17 ± 0.07 mm proximally and 0.25 ± 0.24 mm distally). At 30-day clinical follow-up, one case of myocardial infarction was reported. At six months, the angiographic mean in-stent late loss was 0.95 ± 0.76 mm. By OCT, a high percentage of struts was covered (97.6 ± 15.00 %) with a mean neointimal thickness of 0.31 ± 0.14 mm, all edge dissections were clinically silent and healed. Target lesion revascularisation (TLR) occurred in 11 patients (23.4%) and clinically driven TLR in three of these patients (6.4%). No cases of death or stent thrombosis were reported during the study. CONCLUSIONS: Implantation of the Svelte stent IDS was observed to be safe, feasible and associated with a low acute vascular injury and a high percentage of strut coverage at 6-month follow-up.

  • clinical and angiographic outcomes following first in man implantation of a novel thin strut low profile fixed wire stent the svelte coronary stent Integrated Delivery System first in man trial
    Eurointervention, 2013
    Co-Authors: Roberto Diletti, Robert Jan Van Geuns, Nicolas M Van Mieghem, Hector M Garciagarcia, Richard Spencer, Pierfrancesco Agostoni, Vasim Farooq, Christos V Bourantas, Takashi Muramatsu, J. De Schepper
    Abstract:

    textabstractAims: The Svelte Stent Integrated Delivery System (IDS) is a novel fixed-wire thin-strut cobalt-chromium stent characterised by a very low entry profile. The aim of the present study is to evaluate the safety and the feasibility of the Svelte stent IDS implantation in humans. Methods and results: The present investigation is a prospective, multicentre non-randomised single-arm study. The primary endpoint was freedom from major adverse cardiac events (MACE) at 30 days post-procedure. Invasive follow-up was scheduled at six months post implantation. A total of 47 patients were enrolled and serial OCT imaging was performed in a subgroup of 18 patients. At the index procedure the lesion success rate was 97.9% (46 patients), the mean acute gain was 1.56±0.43 mm with a mean minimum lumen diameter of 2.48±0.43 mm. Post-implantation OCT imaging revealed a minimal mean prolapse area (0.10±0.06 mm2), mean incomplete stent apposition area (0.12±0.13 mm2) and mean intraluminal mass area (0.05±0.03 mm2). Edge dissections were reported in eight cases (mean dissection width 0.17±0.07 mm proximally and 0.25±0.24 mm distally). At 30-day clinical follow-up, one case of myocardial infarction was reported. At six months, the angiographic mean in-stent late loss was 0.95±0.76 mm. By OCT, a high percentage of struts was covered (97.6 ±15.00%) with a mean neointimal thickness of 0.31±0.14 mm, all edge dissections were clinically silent and healed. Target lesion revascularisation (TLR) occurred in 11 patients (23.4%) and clinically driven TLR in three of these patients (6.4%). No cases of death or stent thrombosis were reported during the study. Conclusions: Implantation of the Svelte stent IDS was observed to be safe, feasible and associated with a low acute vascular injury and a high percentage of strut coverage at 6-month follow-up.

Roberto Diletti - One of the best experts on this subject based on the ideXlab platform.

  • clinical and angiographic outcomes following first in man implantation of a novel thin strut low profile fixed wire stent the svelte coronary stent Integrated Delivery System first in man trial
    Eurointervention, 2013
    Co-Authors: Roberto Diletti, Hector M Garciagarcia, Richard Spencer, Pierfrancesco Agostoni, Vasim Farooq, Christos V Bourantas, Takashi Muramatsu, Robert Jan Van Geuns, Nicolas M Van Mieghem, J. De Schepper
    Abstract:

    AIMS: The Svelte Stent Integrated Delivery System (IDS) is a novel fixed-wire thin-strut cobalt-chromium stent characterised by a very low entry profile. The aim of the present study is to evaluate the safety and the feasibility of the Svelte stent IDS implantation in humans. METHODS AND RESULTS: The present investigation is a prospective, multicentre non-randomised single-arm study. The primary endpoint was freedom from major adverse cardiac events (MACE) at 30 days post-procedure. Invasive follow-up was scheduled at six months post implantation. A total of 47 patients were enrolled and serial OCT imaging was performed in a subgroup of 18 patients. At the index procedure the lesion success rate was 97.9% (46 patients), the mean acute gain was 1.56 ± 0.43 mm with a mean minimum lumen diameter of 2.48 ± 0.43 mm. Post-implantation OCT imaging revealed a minimal mean prolapse area (0.10 ± 0.06 mm²), mean incomplete stent apposition area (0.12 ± 0.13 mm²) and mean intraluminal mass area (0.05 ± 0.03 mm²). Edge dissections were reported in eight cases (mean dissection width 0.17 ± 0.07 mm proximally and 0.25 ± 0.24 mm distally). At 30-day clinical follow-up, one case of myocardial infarction was reported. At six months, the angiographic mean in-stent late loss was 0.95 ± 0.76 mm. By OCT, a high percentage of struts was covered (97.6 ± 15.00 %) with a mean neointimal thickness of 0.31 ± 0.14 mm, all edge dissections were clinically silent and healed. Target lesion revascularisation (TLR) occurred in 11 patients (23.4%) and clinically driven TLR in three of these patients (6.4%). No cases of death or stent thrombosis were reported during the study. CONCLUSIONS: Implantation of the Svelte stent IDS was observed to be safe, feasible and associated with a low acute vascular injury and a high percentage of strut coverage at 6-month follow-up.

  • clinical and angiographic outcomes following first in man implantation of a novel thin strut low profile fixed wire stent the svelte coronary stent Integrated Delivery System first in man trial
    Eurointervention, 2013
    Co-Authors: Roberto Diletti, Robert Jan Van Geuns, Nicolas M Van Mieghem, Hector M Garciagarcia, Richard Spencer, Pierfrancesco Agostoni, Vasim Farooq, Christos V Bourantas, Takashi Muramatsu, J. De Schepper
    Abstract:

    textabstractAims: The Svelte Stent Integrated Delivery System (IDS) is a novel fixed-wire thin-strut cobalt-chromium stent characterised by a very low entry profile. The aim of the present study is to evaluate the safety and the feasibility of the Svelte stent IDS implantation in humans. Methods and results: The present investigation is a prospective, multicentre non-randomised single-arm study. The primary endpoint was freedom from major adverse cardiac events (MACE) at 30 days post-procedure. Invasive follow-up was scheduled at six months post implantation. A total of 47 patients were enrolled and serial OCT imaging was performed in a subgroup of 18 patients. At the index procedure the lesion success rate was 97.9% (46 patients), the mean acute gain was 1.56±0.43 mm with a mean minimum lumen diameter of 2.48±0.43 mm. Post-implantation OCT imaging revealed a minimal mean prolapse area (0.10±0.06 mm2), mean incomplete stent apposition area (0.12±0.13 mm2) and mean intraluminal mass area (0.05±0.03 mm2). Edge dissections were reported in eight cases (mean dissection width 0.17±0.07 mm proximally and 0.25±0.24 mm distally). At 30-day clinical follow-up, one case of myocardial infarction was reported. At six months, the angiographic mean in-stent late loss was 0.95±0.76 mm. By OCT, a high percentage of struts was covered (97.6 ±15.00%) with a mean neointimal thickness of 0.31±0.14 mm, all edge dissections were clinically silent and healed. Target lesion revascularisation (TLR) occurred in 11 patients (23.4%) and clinically driven TLR in three of these patients (6.4%). No cases of death or stent thrombosis were reported during the study. Conclusions: Implantation of the Svelte stent IDS was observed to be safe, feasible and associated with a low acute vascular injury and a high percentage of strut coverage at 6-month follow-up.

Pieter R. Stella - One of the best experts on this subject based on the ideXlab platform.

  • direct implantation of rapamycin eluting stents with bioresorbable drug carrier technology utilising the svelte coronary stent on a wire the direct ii study
    Eurointervention, 2016
    Co-Authors: Stefan Verheye, Pieter R. Stella, Ahmed Anower Khattab, Jozef Bartunek, Didier Carrié, Ton Slagboom, Yoshinobu Onuma, Patrick W.j.c. Serruys
    Abstract:

    Aims: Our aim was to demonstrate the safety and efficacy of the Svelte sirolimus-eluting coronary stenton-a-wire Integrated Delivery System (IDS) with bioresorbable drug coating compared to the Resolute Integrity zotarolimus-eluting stent with durable polymer in patients with de novo coronary artery lesions. Methods and results: Direct stenting, particularly in conjunction with transradial intervention (TRI), has been associated with reduced bleeding complications, procedure time, radiation exposure and contrast administration compared to conventional stenting with wiring and predilatation. The low-profile Svelte IDS is designed to facilitate TRI and direct stenting, reducing the number of procedural steps, time and cost associated with coronary stenting. DIRECT II was a prospective, multicentre trial which enrolled 159 patients to establish non-inferiority of the Svelte IDS versus Resolute Integrity using a 2:1 randomisation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Target vessel failure (TVF), as well as secondary clinical endpoints, will be assessed annually up to five years. At six months, in-stent LLL was 0.09±0.31 mm in the Svelte IDS group compared to 0.13±0.27 mm in the Resolute Integrity group (p<0.001 for non-inferiority). TVF at one year was similar across the Svelte IDS and Resolute Integrity groups (6.5% vs. 9.8%, respectively). Conclusions: DIRECT II demonstrated the non-inferiority of the Svelte IDS to Resolute Integrity with respect to in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups. ClinicalTrials.gov Identifier: NCT01788150

  • svelte Integrated Delivery System performance examined through diagnostic catheter Delivery the speed registry
    Catheterization and Cardiovascular Interventions, 2015
    Co-Authors: Ahmed Anower Khattab, Freek Nijhoff, Steffen Brucks, Fabian Nietlispach, Joachim Schofer, Julien Berland, Pierfrancesco Agostoni, Bernhard Meier, Pieter R. Stella
    Abstract:

    Aims The multi-center SPEED registry evaluated the procedural success and in-hospital clinical outcomes of direct stenting with the Svelte ‘all-in-one’ coronary stent Integrated Delivery System (IDS) through diagnostic catheters to identify the clinical indications for which this approach is appropriately suited. Methods & results Forty-eight (48) patients with 54 lesions of lengths ≤20 mm and RVD 2.5–3.5 mm were targeted for direct stenting through diagnostic catheters (4–6F) via radial or femoral approach. Procedural characteristics early in an investigator's experience (28 lesions) were compared with outcomes following experience (26 lesions). Procedure, device and strategy success were realized in 54 (100%), 50 (93%) and 46 (85%) lesions, respectively, with strategy success significantly related to RVD (P = 0.05), lesion location (P = 0.01), and diagnostic catheter size (P = 0.05). Significant improvement in crossing and intervention time and trends toward improvement in device and strategy success, reductions in procedure and radiation time and contrast use were observed. Conclusions Direct stenting through diagnostic catheters via radial or femoral approach using the Svelte IDS is feasible and associated with good in-hospital outcomes. This approach offers the attractive option of assessing lesions via diagnostic catheter and, depending upon vessel anatomy and lesion morphology, continuing with ad-hoc interventional treatment using the same diagnostic catheter. Improvements in strategy success and procedural efficiencies, based on operator experience, facilitate catheter downsizing and reduce intervention time, ancillary product use and overall procedure costs. © 2014 Wiley Periodicals, Inc.

  • tct 196 preliminary results from the direct ii study a prospective randomized active control multi center non inferiority study comparing the safety and efficacy of the svelte drug eluting coronary stent ids to the medtronic vascular santa rosa ca re
    Journal of the American College of Cardiology, 2013
    Co-Authors: Stefan Verheye, Robert Jan Van Geuns, Pieter R. Stella, Julien Berland, Jozef Bartunek, Didier Carrié, Ton Slagboom, Victor Legrand, Mathias Vrolix
    Abstract:

    The Svelte (New Providence, NJ) drug-eluting stent (DES) combines sirolimus with a novel, amino acid-based (PEA) bioabsorbable drug carrier. The stent is mounted on an Integrated Delivery System (IDS) consisting of a low compliant balloon with balloon control bands (BCBs) enveloping the balloon