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 grade

Stent 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 !!!!