BIODEGRADABLE PERIPHERAL IGAKI-TAMAI STENTS PERSEUS STUDIES

Transcription

1 BIODEGRADABLE PERIPHERAL IGAKI-TAMAI STENTS PERSEUS STUDIES G.Biamino University of Leipzig Heart Center Department of Clinical and Interventional Angiology Leipzig, Germany

2 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.

3 Rationale for Biodegradable Stents Concerns 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

4 THE NEW NIGHTMARE In SFA Stent fractures and In-stent restenoses

5 Rationale for Biodegradable Stents Restenosis commonly occurs within 4-9 months after endovascular interventions The clinical need for stent scaffolding is limited after this period Stents made of absorbable materials may be an ideal alternative Absorbable stents can also be useful for the local administration of pharmacological agents

6 IGAKI - TAMAI STENT Biodegradable Peripheral Stent

7 Stent Specification Material composition PLLA(poly-L-lactic acid) medical grade Stent design Strut thickness Available length Available diameter Expansion range Polymer cross-sectional area (expanded) Percentage shortening on expansion Polymer surface area (expanded) Longitudinal flexibility Stent of radio-opaque markers Ferromagnetism MRI Zig zag herical coil 0.24 mm(0.009inch) 36mm 5.0, 6.0, 7.0, 8.0 mm 7mm(stent type at 5mm and 6mm) 9mm(stent type at 7mm and 8mm) 0.68mm 2 < 1.6% (at 5mm), < 1.9%(at 6mm), < 3.2%(at 7mm), < 3.7%(at 8mm) 21.17% (at 5mm), 17.69%(at 6mm), 17.22% (at 7mm), 15.27%(at 8mm) Excellent Proximal and distal edges Non Compatible

8 Peripheral Stent Delivery System Balloon-expandable system covered with a protective sheath 8F 60cm Protective sheat: System length: Balloon length: Balloon size: Outer diameter; 8F 60 cm and 120 cm 4 cm (Stent lenth 36 mm) 6.0, 7.0, 8.0 mm

9 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 6-7 cm

10 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.

11 PERSEUS- Study Endpoints Primary technical success rate Major adverse events Vessel ruptur Acute and subacute stent thrombosis Stent migration AMI Death

12 PERSEUS- Study Endpoints Follow-up at 1,3,6,12,24 mo Primary,primary-assisted and secundary patency rate at 12 and 24 months Number of reinterventions

13 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

14 G.H.1

15 G.H.2

16 G.H.3

17 G.H.5

18 PERSEUS- Study Results Primary success rate 100 % No serious adverse event

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20 Pre Intra Post

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22 6 - Months Follow-up Results NO acute or subacutereocclusions 25 % symptomatic restenoses, all successfully retreated Asymptomatic restenoses (max %) in 18%.

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26 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

27 IGAKI-TAMAI TM STENT 78 mm Material composition : PLLA(poly-L-lactic acid) medical grade Stent design : Zig zag helical coil Strut thickness : inch (0.24 mm) Radio-opaque markers : 2 gold markers Currently available diameters : 5.0 mm Currently available length : 78 mm

28 Stent Delivery System Balloon-expandable system covered with a protective sheath 7 8FF cm 110cm Protective sheath : Outer diameter; 7 F System length : 110 cm Balloon length : 8 cm (Stent length 78 mm) Balloon size : 5.0 mm

29 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 15 cm

30 PERSEUS- Study Results Primary success rate 100 % No serious adverse event

31 DIFFUSE PAOD WITH BILATERAL FUNCTIONAL SFA OCCLUSION Ea.1

32 BEFORE AFTER PTA Rigth SFA Ea.2 Ea.3

33 STENTING DISTAL PROXIMAL E.3 E.4

34 AFTER LONG INFLATION AFTER STENTING Rigth SFA Ea.4 Ea.5

35 BEFORE AFTER PTA Left SFA E.1 E.2

36 FINAL RESULT E.5 E.6

37 3 Months Follow - up No major adverse events No acute or subacute occlusion No symptomatic re-stenoses!!!!!

38 6 - Months Results Two reocclusions successfully retreated 28 % symptomatic restenoses, all successfully retreated Asymptomatic angiographic restenosis ( 50-60%) in 6 cases

39 6 10 months Follow-up Primary assisted patency rate 93% Secondary patency rate 100%

40 End of the presentation

41 Perseus He killed the monster Medusa; and we are comparing Medusa with METAL STENTS!!!!

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