PCI Unmet Clinical Needs

Slides:



Advertisements
Similar presentations
Clinical Trial Results. org ABSORB Presented at the American College of Cardiology Annual Scientific Session March, 2007 Presented by Dr. Patrick W. Serruys.
Advertisements

Stenting: tips and tricks
Copyleft Clinical Trial Results. You Must Redistribute Slides PEPCAD II ISR Study Paclitaxel-eluting devices: randomized comparison of the SeQuent™ please.
“Real World”: SVG, De Novo or Restenotic Coronary Artery Lesions Chronic Stable Angina, Silent Ischemia, Acute Coronary Syndromes Vessel Diameters:
M.Unverdorben; ACC March 2008 Martin Unverdorben Rotenburg/Fulda, Germany and Richmond, VA, USA Clinical Research Institute, Center for Cardiovascular.
Distal Protection: PRIDE, CAPTIVE Symbiot III, AiMI Dr James Cotton MD MRCP Heart and Lung Centre Wolverhampton.
Www. Clinical trial results.org The RAVEL Study A RAndomised (double blind) study with the Sirolimus coated BX™ VElocity balloon expandable stent (CYPHER™)
W e m a k e i d e a s c o m e a l i v e 001IHP For internal use only Not only a peripheral stent available in Renal sizes...
A PROSPECTIVE MULTICENTRE REGISTRY FOR THE ASSESSMENT OF SAFETY AND EFFICACY OF BIODEGRADABLE POLYMER COATED, PACLITAXEL ELUTING STENT LUC TM * *(BALTON,
AVE Micro Stent KFSH & RC Experience with 6 months Angiographic Follow Up Layth A. Mimish, M. Bakhshi, F. Al-Nozha, A. Kinsara, O. Amoudi, J. Buraiki,
29th ANNUAL SCIENTIFIC SESSIONS – SCA&I
APPOSITION II study results Robert-Jan van Geuns, MD On behalf of the APPOSITION II Investigators.
Dr. V.K.AJIT KUMAR PROFESSOR, DEPT. of CARDIOLOGY, SCTIMST, TRIVANDRUM STENT CHOICE IN AMI.
DIABETES trial P Jiménez-Quevedo, M Sabaté, DJ Angiolillo, JA Gómez-Hospital, R Hernández-Antolín, J Goicolea, F Alfonso, C Bañuelos, J Escaned, R Moreno,
M.Unverdorben; TCT Problem The treatment of stenoses of small coronary arteries (SVD) and of restenoses after stent deployment (ISR) still show.
Chaim Lotan MD, Yaron Almagor MD, Karel Kuiper MD, M.J. Suttorp MD, William Wijns MD The SICTO Study CYPHER TM Sirolimus-eluting stent in Chronic Total.
As presented by Patrick W. Serruys, MD, PhD, FACC Principal Investigator Thoraxcentre - Erasmus University Rotterdam, The Netherlands PISCES Paclitaxel.
SCAAR UCR SWEDEN 2007 Stefan James, Jörg Carlsson, Johan Lindbäck, Tage Nilsson, Ulf Stenestrand, Lars Wallentin and Bo Lagerqvist for the SCAAR study.
Proxis Proximal embolic protection in saphenous vein graft and infarct PCI Dan Blackman Leeds General Infirmary Advanced Angioplasty 2006.
Confidential: Internal Use only 1 Click to edit Master title style Click to edit Master text styles – Second level Third level – Fourth level » Fifth level.
Tetra Randomized European Direct Stenting Study (TRENDS)
TAXUS IV 2-Year Clinical Results The safety and effectiveness of the TAXUS TM Express 2TM Paclitaxel-Eluting Coronary Stent System have been established.
Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons Presented at The American Heart Association Scientific Session 2006 Presented by Dr.
SIROLIMUS-ELUTING STENTS EFFECTIVELY INHIBIT NEOINTIMAL PROLIFERATION AS COMPARED TO BARE METAL STENTS IN DISEASED SAPHENOUS VEIN GRAFTS: 6-month IVUS.
RESEARCH, REDUCE III, X-AMINE ST, COOL-MI Azfar Zaman Freeman Hospital, Newcastle.
FRONTIER Registry The Guidant MULTI-LINK FRONTIER ™ Coronary Stent System for the Treatment of Pts with Native De Novo or Restenotic Bifurcation Coronary.
LONG-TERM OUTCOMES OF PERCUTANEOUS CORONARY INTERVENTION FOR UNPROTECTED LEFT MAIN CORONARY ARTERY DISEASE: INITIAL CLINICAL EXPERIENCE. Graidis Ch. 1,
Slow-rate release polymer-based paclitaxel- eluting stent compared with bare stent in patients with single complex coronary lesions TAXUS V Presented at.
A Prospective, Randomized Trial Evaluating a Paclitaxel-Eluting Balloon in Patients TReated with Endothelial Progenitor Cell CapTuring Stents for De Novo.
Direct Stenting is Better (Debate Session) 동아의대 김 무 현.
New strategies and perfusion/aspiration devices for primary PCI Sandra Garcia Cruset, PhD. Cordynamic B.U. Marketing Manager.
Clinical Experience with the Bio Active Stent (BAS) in FINLAND 9 e CFCI Hotel Meridien Etoile Paris, France 10 Octobre 2007 Pasi Karjalainen, MD, PhD.
Endeavor 4: A Randomized Comparison of a Zotarolimus- Eluting Stent and a Paclitaxel- Eluting Stent in Patients with Coronary Artery Disease Martin B.
Www. Clinical trial results.org Cypher sirolimus-eluting stent Primary Endpoint:  In-stent and late lumen loss at 9 months (determined by QCA) Secondary.
Effect of Intravascular Ultrasound- Guided vs. Angiography-Guided Everolimus-Eluting Stent Implantation: the IVUS-XPL Randomized Clinical Trial Myeong-Ki.
The MASTER Trial A Prospective, Randomized, Multicenter Evaluation of a PET Micronet Mesh Covered Stent (MGuard) in STEMI Sigmund Silber, MD, PhD FESC,
Drug Eluting Balloon in Acute Myocardial Infarction: (PI) On behalf of the DEB-AMI study group (PI) P.R. Stella, MD, PhD 6 month.
The SAFER Trial Evaluation of the Clinical Safety and Efficacy of the PercuSurge GuardWire in Saphenous Vein Graft Intervention As presented at TCT 2000.
Columbia University Medical Center Cardiovascular Research Foundation New York City, NY Akiko Maehara, MD Use of IVUS Reduces Stent Thrombosis and Myocardial.
Cardioprotective Effects of Postconditioning in Patients Treated with Primary PCI Evaluated with Magnetic Resonance Jacob T Lønborg Niels Vejlstrup, Erik.
A Prospective, Randomized Trial of a Paclitaxel coated Balloon vs. uncoated Balloon Angioplasty in Patients with Drug- Eluting Stent Restenosis PEPCAD-DES.
Learning Objectives Drawbacks of traditional POBA
End points in PTCA trials. A successful angioplasty is defined as the reduction of a minimum stenosis diameter to
The OPTIMAX first-in-man study Mid-term clinical outcome of Titanium-Nitride-Oxide-coated Cobalt Chromium stents in patients with de novo coronary artery.
Ospedale San Raffaele, Milan, Italy
My initial ABSORB experience Assoc. Prof. I. Petrov
RevElution Clinical Trial
LONG-DES II Trial Randomized Comparison of the Efficacy of Sirolimus-Eluting Stent Versus Paclitaxel-Eluting Stent in the Treatment of Long Native Coronary.
TAXUS IV Trial Slow-rate release polymer-based paclitaxel-eluting stent compared with bare stent in patients with single de novo coronary lesions Presented.
BVS Expand: First Results of Wide Clinical Applications
EXCELLA Studies - Novolimus Elution from PLLA Polymer Coated Stents DESyne® and DESyne BD: Design Specifications and Clinical Updates Stefan Verheye,
The XIENCE V EXCEED Study
The Biofreedom Surface Etching Polymer-Free DES System
Stenting of Coronary Arteries in Non Stress/Benestent Disease
Long-term follow-up of the DIABETES I (DIABETes and sirolimus Eluting Stent) trial: P Jiménez-Quevedo, M Sabaté, DJ Angiolillo, JA Gómez-Hospital, R Hernández-Antolín,
American College of Cardiology Presented by Dr. Stephan Windecker
REALITY: 8 month results
Giuseppe Biondi Zoccai, MD
SIRIUS: A U.S. Multicenter, Randomized, Double-Blind Study of the SIRolImUS-Eluting Stent in De Novo Native Coronary Lesions Presented at TCT 2002.
Incidence and management of restenosis after treatment of unprotected left main disease with drug-eluting stents: 70 restenotic cases from a cohort of.
NEW GENERATION STENT COBALT-CHROMIUM SIROLIMUS ELUTING STENT.
12-month clinical and 13-month angiographic outcomes from a randomized trial evaluating the Absorb Bioresorbable Vascular Scaffold vs. metallic drug-eluting.
Martin B. Leon, David R. Holmes, Dean J. Kereiakes, Jeffrey J
Impact of Diabetes Mellitus on Long-term Outcomes in the
Maintenance of Long-Term Clinical Benefit with
ISAR-LEFT MAIN: A Randomized Clinical Trial on Drug-Eluting Stents for Unprotected Left Main Lesions J. Mehilli, MD Deutsches Herzzentrum Technische.
ISAR-LEFT MAIN: A Randomized Clinical Trial on Drug-Eluting Stents for Unprotected Left Main Lesions J. Mehilli, MD Deutsches Herzzentrum Technische.
Sirolimus Stent vs. Bare Stent in Acute Myocardial Infarction Trial
The American College of Cardiology Presented by Dr. A. Abazid
TYPHOON Trial Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON) Trial Presented at.
Presentation transcript:

PCI Unmet Clinical Needs For SVG Distal embolisation No reflow High rate of restenosis For AMI / other thrombus loaded lesions Patients with DES Late ST due to incomplete endothelialization Bleeding complications due to long term Plavix use

The Evolution of Stents Bare Metal Drug Eluting 1st Generation 2nd MGuard 3rd While addressing the restenosis problem, today's stent technology overlooks the adverse effects of acute embolization

About MGuard’s Technology Micron Circular Knitting Technology Net Material: Poly Ethylene Terephthalate (PET) Fiber diameter: 20 μm Aperture size at expanded state: ~180μm X 200μm System profile - 1.3mm Net secured to the distal and proximal end of the stent

About MGuard’s Technology The stent is wrapped with the ultra-thin polymer meshed net The net is designed for maximal flexibility without compromising the strength of the fiber The net expands seamlessly when the stent is deployed

About MGuard’s Clinical Benefits MGuard is designed to Trap thrombotic material to protect bloodstream from embolic debris Reduce vessel injury and restenosis rate Maintain standard procedure Injury lowered by MGuard

About MGuard’s Clinical Benefits MGuard Lifelong Embolic Protection MGuard blocks embolic showers and plaque detachment from the arterial wall, blocking debris at the source during and post procedure. MGuard addresses the risk of suboptimal perfusion and no-reflow in occluded lesions.

About MGuard’s Clinical Benefits Lower arterial wall trauma MGuard’s net diffuses the stent pressure, creating a snow shoe effect to lower vessel trauma and injury*. This leads to a reduction in restenosis compared to BMS**.

About MGuard’s Clinical Benefits Maintaining standard procedure MGuard’s standard crossing profile and dilatation pressures make deliverability and deployment equivalent to a conventional balloon inflated stent.

MGuard Trials Preclinical - Coronary Porcine Study MGuard FIM Trial The GUARD Trial - Brazil Multicenter Study The MAGICAL Study MGuard in Acute MI Trial iMOS – MGuard International Registry

Animal Trials Porcine studies by CBSET Inc. Cambridge, MA A comparison of MGuard with standard BMS Methods 9 Swine with a total of 21 stents: 5 MGuard, 6 BMS (control) 6 Month FU Trial Results No animal morbidity No device thrombosis Low inflammatory response (0.8 ± 0.3 on a scale of 0-3) Low Schwartz injury score (0.15 ± 0.1) Exceptionally good endothelization (4 ± 0)

Preclinical Safety Study Histology: 30 Days Post-Implantation 10X BMS MGuard

Injury Score

Inflammation Score

Neointimal Thickness

MGuard First in Man Study Primary endpoint: 30 days MACE Secondary endpoints: Device success Procedural success TIMI flow post procedure 6 Months MACE 6 Months Late Lumen Loss Participating centers: Eberhard Grube ; Helios Heart Center, Siegburg, Germany Karl Eugen Hauptmann ; Trier, Germany

FIM Clinical Results Protocol amended to obtain long term (> 1y) results – Results expected by April 2009

Case Report #1 - MGuard in SVG 78 year old female with history of hypercholesterolemia, hypertension, smoking and diabetes. Coronary artery bypass surgery in 1993 and presented with progressive angina (CCS-III). Coronary angiography revealed subtotal occluded (99%) vein graft to the Right Coronary Artery. 2 MGuard stents were implanted Procedural success with: No clinical adverse events No CPK rise No no-reflow post PCI

Case Report #1 - MGuard in SVG Pre-PCI POST MGuard

Case Report #2 - MGuard in SVG with IVUS 60 year old male Proximal SVG (1995) lesion 4mm lumen diameter 80% stenosis 4X15 MGuard stent 6 months No ISA; % St obstruction = 17% Baseline No ISA; St expansion= 98.9%

Case Report #3 - MGuard in Acute MI Totally Occluded LAD The Thrombus Visible

Case Report #3 - MGuard in Acute MI Final Result The procedure was completed with optimal results and an absence of any angiographic complications.

MGuard Technical Data Stent : Stent material: Stainless steel 316 Stent design: Low profile Strut thickness: 100μm, low profile stent design. Catheter: Rapid exchange delivery system 0.014” guide wire compatible Guiding catheter: 6F Nominal Pressure: 6 atm. Rated Burst Pressure: ≤ 3.0 mm: 16 atm. ≥ 3.5 mm: 14 atm. Radio-opaque markers: Proximal and Distal Balloon Characteristic: Semi - compliant Usable Catheter Length: 1420 mm ± 20 mm