BIODEGRADABLE PERIPHERAL IGAKI-TAMAI STENTS â€‍ .BIODEGRADABLE PERIPHERAL IGAKI-TAMAI...

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Transcript of BIODEGRADABLE PERIPHERAL IGAKI-TAMAI STENTS â€‍ .BIODEGRADABLE PERIPHERAL IGAKI-TAMAI...

  • BIODEGRADABLE PERIPHERAL

    IGAKI-TAMAI STENTS

    PERSEUS STUDIES

    G.Biamino

    University of Leipzig Heart Center

    Department of Clinical and Interventional Angiology

    Leipzig, Germany

  • Rationale for Biodegradable Stents

    Although remarkable technological

    advances had led to the development of

    very effective Nitinol stents dedicated to

    the SFA, which offer the promise of

    addressing both the problems of acute

    reocclusion and late restenosis after

    PTA, many concerns remain.

  • Rationale for Biodegradable Stents

    Metallic stents induce

    - varying degree of thrombogenesis

    - significant initial hyperplasia, with

    restenosis rates 15 40%

    Long term effects of metallic stents in human

    arteries are still unknown

    Metallic stents remaining in place may be

    obstacles to additional treatments

    Concerns

  • Stent fractures

    and

    In-stent

    restenoses

    THE NEW

    NIGHTMARE

    In SFA

  • Rationale for Biodegradable Stents

    Restenosis commonly occurs within 4 - 9months after endovascular interventions

    The clinical need for stent scaffolding islimited after this period

    Stents made of absorbable materials may bean ideal alternative

    Absorbable stents can also be useful for thelocal administration of pharmacologicalagents

  • IGAKI - TAMAI STENT

    Biodegradable Peripheral Stent

  • CompatibleMRI

    NonFerromagnetism

    Proximal and distal edgesStent of radio-opaque markers

    ExcellentLongitudinal flexibility

    21.17% (at 5mm), 17.69%(at 6mm),

    17.22% (at 7mm), 15.27%(at 8mm)

    Polymer surface area (expanded)

    < 1.6% (at 5mm), < 1.9%(at 6mm),

    < 3.2%(at 7mm), < 3.7%(at 8mm)

    Percentage shortening on expansion

    0.68mm2Polymer cross-sectional area

    (expanded)

    7mm(stent type at 5mm and 6mm)

    9mm(stent type at 7mm and 8mm)

    Expansion range

    5.0, 6.0, 7.0, 8.0 mmAvailable diameter

    36mmAvailable length

    0.24 mm(0.009inch)Strut thickness

    Zig zag herical coilStent design

    PLLA(poly-L-lactic acid) medical gradeMaterial composition

    Stent Specification

  • Peripheral Stent Delivery System

    8F

    60cm60cm

    8F

    Balloon-expandable system covered with a protective sheath

    6.0, 7.0, 8.0 mmBalloon size:

    4 cm (Stent lenth 36 mm)Balloon length:

    60 cm and 120 cmSystem length:

    Outer diameter; 8FProtective sheat:

  • PERSEUS- Study design

    Prospective, non-randomized, two

    centers pilot study

    Ruth-Class 2-3 patients with de novo

    lesions of the SFA, Type A, B and C

    Max. 2 stents were permitted, limiting

    the length of the lesion to cm6 - 7

  • PERSEUS- Study Objectives

    The aim of the study was to

    demonstrate the feasibility and

    safety of a new biodegradable

    polymer poly-l-lactid (PLLA) stent in

    patients with suitable SFA lesions.

  • PERSEUS- Study Endpoints

    Primary technical success rate

    Major adverse events

    Vessel ruptur

    Acute and subacute stent

    thrombosis

    Stent migration

    AMI

    Death

  • PERSEUS- Study Endpoints

    Primary,primary-assisted and

    secundary patency rate at 12 and

    24 months

    Number of reinterventions

    Follow-up at 1,3,6,12,24 mo

  • PERSEUS- Study Population

    N = 103 patients scheduled for

    PTA St. IIb

    Lesions location SFA

    Lesion length 4.5 cm (+/-1.2 cm)

    Stenting on indication

  • G.H.1

  • G.H.2

  • G.H.3

  • G.H.5

  • PERSEUS- Study Results

    Primary success rate 100 %

    No serious adverse event

  • Pre Intra

    Post

  • 6 - Months Follow-up Results

    NO acute or subacutereocclusions

    25 % symptomatic restenoses , all

    successfully retreated

    Asymptomatic restenoses

    (max. 50 -60%) in 18%.

  • Conclusion

    The Biodegradable PLLA IGAKI-

    TAMAI-Stent is safe

    Stenting of the SFA is feasible

    Primary Assisted Patency Rate 100 %

    in this first pilot-study

    The encouraging results have to be

    validated in larger trials including more

    complex lesions

  • Material composition : PLLA(poly-L-lactic acid) medical gradeStent design : Zig zag helical coilStrut thickness : 0.009 inch (0.24 mm)Radio-opaque markers : 2 gold markersCurrently available diameters : 5.0 mmCurrently available length : 78 mm

    IGAKI-TAMAITM STENT

    78 mm

  • Stent Delivery System

    Protective sheath : Outer diameter; 7 FSystem length : 110 cmBalloon length : 8 cm (Stent length 78 mm)Balloon size : 5.0 mm

    8F

    60cm110cm

    7 F

    Balloon-expandable system covered with a protective sheath

    0.018

  • PERSEUS II- Study design

    Prospective, non-randomized, pilot

    study ( Leipzig and Mercogliano)

    65 patients with de novo lesions of

    the SFA, Type B and C

    Max. 2 stents were permitted, limiting

    the length of the lesion to cm15

  • PERSEUS- Study Results

    Primary success rate 100 %

    No serious adverse event

  • Ea.1

    DIFFUSE PAOD WITH BILATERAL

    FUNCTIONAL SFA OCCLUSION

  • BEFORE AFTER PTA

    Ea.3Ea.2

    Rigth

    SFA

  • STENTING

    DISTAL PROXIMAL

    E.4E.3

  • Ea.5Ea.4

    AFTER LONG

    INFLATION AFTER STENTING

    Rigth

    SFA

  • E.1

    Left

    SFA

    E.2

    BEFORE AFTER PTA

  • FINAL RESULT

    E.5 E.6

  • 3 Months Follow - up

    No major adverse events

    No acute or subacute occlusion

    No symptomatic re-stenoses !!!!!

  • 6 - Months Results

    Two reocclusionssuccessfully retreated

    28 % symptomatic restenoses,all successfully retreated

    Asymptomatic angiographicrestenosis ( 50-60%) in 6 cases

  • 6 10 months Follow-up

    Primary assisted patency rate

    Secondary patency rate

    93%

    100%

  • End of the presentation

  • Perseus

    He killed the monster Medusa;

    and we are comparing Medusa

    with

    METAL STENTS !!!!