The Illumina FIH study with a next generation DES 12-months results
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1 The Illumina FIH study with a next generation DES 12-months results Dierk Scheinert, MD Head of Medical Department V - Angiology University of Leipzig Medical Center, Germany
2 Disclosure Dierk Scheinert, MD Advisory Board /Consultant: Abbott, Biotronik, Boston Scientific, Cook Medical, Cordis, CR Bard, Gardia Medical/Allium, Medtronic, TriReme Medical, Trivascular, Upstream Peripheral Technologies
3 NiTiDES features description
4 ILLUMINA study design Innovative sirolimus self expanding drug-eluting stent for the treatment of peripheral disease: evaluation of safety and efficacy Prospective, Single arm ; 10 centers in Europe (n= 100 pts) Prof. Dierk Scheinert (Coordinating Clinical Investigator, Leipzig-Germany) ecrfs; Core Lab; CEC Primary Endpoint: SAFETY: Composite of Major Adverse Events MAE (death, target limb amputation, target limb ischemia requiring surgical intervention or surgical repair of target vessel or clinically-driven target lesion revascularization and freedom from worsening of the Rutherford score by 2 classes, or to class 5 or 6) EFFICACY: Primary patency at 12 months. Primary patency is defined as absence of clinicallydriven target lesion revascularization or binary restenosis (PSVR >2.4 - duplex evaluation) Phone Call Duplex ultrasound Clinical FU 1 month 6 month 12 month 24 month Ongoing
5 ILLUMINA study centers and enrolled pts. Sites Universitätsklinikum Leipzig Scheinert 3 Universitäts-Herzzentrum Freiburg Bad Krozingen Zeller 13 Regiomed GefäBzentrum Sonneberg Thieme 13 St. Gertrauden Krankenhaus GmbH - Berlin Langhoff 17 Total Germany 46 San Raffaele Hospital - Milan Chiesa/Kahlberg 15 Maria Cecilia Hospital - Cotignola Cremonesi 2 Fondazione IRCCS Policlinico San Matteo - Pavia Marone 2 Total Italy 19 Clinique Pasteur - Toulouse Sauguet 24 Polyclinique Les Fleurs - Ollioules Commeau 3 Centre Prive Claude Galien - Quincy Garot 8 Total France 35 Patients GRAND TOTAL 100 N
6 ILLUMINA study baseline Baseline Characteristics Patients enrolled (n) 100 Mean age (y) 67 Male (n) 78 Smoker (n) 39 Diabetic (n) 35 Hypertension (n) 69 Hypercholesterolemia (n) 54
7 ILLUMINA study pre-procedure information Location Calcification Heavy 20% None 25% Middle SFA 49% Distal SFA 38% 55% Moderate 35% Little 20% Proximal SFA 8% Popliteal P1 5% Avg lenght [mm] 72.54±37.99 Lesion RVD [mm] 5.11±0.72
8 ILLUMINA study procedure results Procedure results Stent deployment success 100% Procedural success 100% Stent per patient (n) 1.09 ± 0.32 Total mean length of stent (mm) 86.7 ± 40.8
9 ILLUMINA study 12 months results: safety Major Adverse Event (MAE) - numbers Clinically driven Target Lesion Revascularization (TLR) 2 Death* 1 Target limb amputation 0 Target limb ischemia requiring surgical intervention or surgical repair of the target vessel Worsening of the Rutherford score by two classes, or class 5 and 6 MAE * Death due to Myocardial Infarction - non stent or procedural related
10 Failure Probability ILLUMINA study 12 months results K-M: safety Objective Performance Goal: 19.3% Safety endpoint Lower 95.00% CL Upper 95.00% CL Remaining at Risk 0-month 0.0% 0.0% 0.0% month 0.0% 0.0% 0.0% 99 6-month 1.1% 0.1% 7.2% month 3.2% 1.1% 9.7% 88
11 Primary Patency ILLUMINA study 12 months results K-M: efficacy Efficacy endpoint Lower 95.00% CL Upper 95.00% CL Remaining at Risk 0-month 100% 100% 100% month 100% 100% 100% 99 6-month 94.7% 87.7% 97.8% month 86.9% 78.0% 92.3% 78
12 Freedom from TLR ILLUMINA study 12 months results K-M: TLR Freedom from TLR Lower 95.00% CL Upper 95.00% CL Remaining at Risk 0-month 100% 100% 100% month 100% 100% 100% 99 6-month 100% 100% 100% month 97.8% 91.5% 99.4% 88
13 ILLUMINA study 12 months results: Rutherford improvement 100% 80% 60% 40% 20% 2.0% 2.0% 67.0% 29.0% 2.2% 6.7% 16.7% 74.4% % Baseline 12-month FU
14 ILLUMINA study conclusions The ILLUMINA MAE rate, 3%, was much lower than the target (objective performance goal) set up together with the Notified Body which was 19.3%. 2 TLR and a high rate of Primary Patency demonstrated excellent device efficacy. Illumina results stand NiTiDES at the top of effectiveness in today DES scenario.
15 The Illumina FIH study with a next generation DES 12-months results Dierk Scheinert, MD Head of Medical Department V - Angiology University of Leipzig Medical Center, Germany
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