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 !!!!
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