Cre8 TM BTK polymer-free DES technology: the Activ8 clinical trial

Transcription

1 Cre8 TM BTK polymer-free DES technology: the Activ8 clinical trial Enrico Maria Marone Vascular Surgery - - San Raffaele ScientificInstitute, Milan - Italy

2 Disclosure Speaker name: Enrico Maria Marone MD I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) x I do not have any potential conflict of interest

3 Drug eluting stents DESN = 74 BMSN = 66 P Primary patency rate 85% 54% <.0001 Freedom from TLR 91% 66% =.001 Bosiers M. et al., J Vasc Surg 2012

4 Cre8 TM BTK: distinctive features Abluminal Reservoir Technology Sirolimus + organic acid BIS: Bio Inducer Surface

5 Abluminal Reservoir Technology Proprietary polymer-free drug release system (Abluminal Reservoir Technology) constituted by reservoirs on the stent's outer surface. ARTERIAL WALL Controlled and directed Drug elution BLOOD FLOW Lack of any polymer and any drug * Cre8 TM BTK drug release kinetic: Peak tissue concentration during the first days 50% drug elution in approximately 18 days 65%-70% drug elution within 30 days Complete drug elution within 90 days * Cre8 implants in rabbit model

6 San Raffaele Milano study - First time use of Cre8 TM technology in BTK lesions - Dec Sept pts. (8 men) Mean age: yy Critical limb ischemia Stenting of at least one infrapopliteal lesions

7 Indications Flow-limiting dissection Heavily calcified lesions with residual stenosis Focal restenosis post PTA with recoiling

8 Residual stenosis post PTA TPT stenosis

9 Residual stenosis post PTA TPT and PT stenting Cre8 TM 3 x 31 mm

10 Residual stenosis post PTA CULOTTE TECHNIQUE Maverick Quantum 2 x 20 mm + 3 x 30 mm

11 Clinical Results N 1 monthfollow up 12 monthsfollow up Patients 10 10/10 (100%) 9/10 (90%) Stents TVR - 0/10 (0%) 3/9 (33%) TLR - 0/10 (0%) 2/9 (22%) Primary patency - 10/10 (100%) 7/9 (77%) Mean follow up: 18 5 months

12 ACTIV8 - Clinical Study A multicenter non randomized study to evaluate performances in patients with critical limb ischemia Patients over 18 years with critical limb ischemia due to de-novo or restenotic lesion(s), in infrapopliteal arteries, associated with ischemic symptoms to be treated with a single/multiple stenting procedure Prospective, Single arm, Post-market 6 centers in Europe (n= 80 pts) Prof. R. Chiesa, Dr. E. M. Marone (Principal Investigators, OSR-Milan) ecrfs;; Core Lab;; CEC Duplex Ultrasound Clinical FU 1 M 6 M 1 Y Angiography (or duplex ultrasoundifangiographyisinappropriate) Primary Endpoint Safety: Efficacy: Major Adverse Events (MAE = death + target limb major/minor unplanned amputation + clinically driven TLR+ stent thrombosis at 12months) Primary patency at 12 months (absence of clinically driven TLR and binary restenosis assessed by angiography or detectable flow measured by Duplex - if angiography is inappropriate).

13 ACTIV8 - Study Flowchart CLINICAL SCREENING: Clinical inclusion & exclusion criteria One or more exclusion criteria fulfilled: PATIENT EXCLUDED All clinicalinclusioncriteria fulfilled ANGIOGRAPHIC SCREENING: Angiographic inclusion & exclusion criteria One or more exclusion criteria fulfilled: PATIENT EXCLUDED All angiographic inclusion criteria fulfilled ENDOVASCULAR TREATMENT CLINICAL FOLLOW-UP 1, 6 months: duplex ultrasound assessment 12 months: angiography assessment or duplex ultrasound if angiography is inappropriate

14 Conclusions The polymer-free Abluminal Reservoir Technology allows for: Targeted and prolonged drug elution to the vessel wall No use of any element possibly cause of an inflammatory stimulus (i.e. polymer) The use of Cre8 TM BTK is feasible and safe in preliminary study The ACTIV8 BTK study has been specifically designed to evaluate Cre8 TM BTK safety and efficacy

15 San Raffaele Scientific Institute Milan, December 11th-13th