CARDIONOVUM

The clinical program
of Cardionovum.

Cardionovum follows an ongoing scientific clinical and post marketing study program on all medical devices.

CARDIONOVUM has more than 1.600 patients
involved in more than 15 trials globally:

CARDIONOVUM clinical program complete overview

Product Name Format PI Hospital Subject No. of patients Type Status Publication
Legflow RAPID RCT de Vries St. Antonius Nieuwgein DCB vs POBA for pre-dilatation of SFA intermediate and long lesions, followed by stenting 176 Multi center Enrollment complete Planned, 1st presentation at VEITH 2015 Planned, presentation at LINC 2016
Magnificent RCT Goverde ZNA Stuivenberg, Antwerp DCB vs POBA-PTA with absence of binary restenosis 138 Multi center Enrollment started  
Ducasse CHU, Bordeaux
REFLOW Registry Bosiers AZ Sinz Blasius, Dendermonde Legflow femopopliteal long lesions vs POBA >15cm Tasc C&D 120 Multi center Enrollment started  
  Registry Sirvent Gonzalez Hospital Germans Tries i Pujol Efficacy of Legflow in infrapoliteal patients with CLI 25 Single center Started Planned
LEG-DEB Retrospective study Stabile TUH Naples Retrospective study on 400 pts with Legflow 400 Single center 200 pts available Planned
  Retrospective study Goverde ZNA Stuivenberg, Antwerp Retrospective FU on 50 pts at 6 and 12 Month 50 Single center Complete Presented at PCR 2015
Aperto APERTO RCT Pattynama Groene Hart Hospital, Gouda Aperto vs POBA in AVF 150 Multi center Started Planned
  RCT Lindsey Belfast City Hospital Aperto / Elutax vs Poba in AVF 135 Multi center Started  
Loan Royal Victoria Belfast  
  Registry Verstandig Share Zedej MC, Jeruzalem DCB in AVF 50 Single center Started  
TOTAL           1244      
Product Name Format PI Hospital Subject No. of patients Type Status Publication
Restore   RCT Di Sciascio Campus Biomedico Rom Comparison of Restore vs Panthera vs In.Pact Falcon 82 Single center Complete Presented at PCR 2015, published in ‘The American Journal of Cardiology’, December 1, 2015.
XLIMUS   Trial Briguori Clinica Mediteranea, Naples XLIMUS DES in highly complex lesions 200 Single center Started Planned
TOTAL           282      

Cardionovum clinical data presented

1. RESTORE – Prof Di Sciascio, Campo Biomedico Univ. Roma, Italy
Presented at EuroPCR Paris 2015

2. RAPID – Dr De Vries, St. Antonius, Nieuwegein
Presented at VEITH 2015, planned for LINC 2016

3. LEGFLOW retrospective – Dr Goverde, ZNA Stuivenberg, Antwerp, Belgium
Presented at EuroPCR Paris 2015

1. RESTORE clinical study:
Efficacy and Safety of Paclitaxel-Coated Balloon for the Treatment
of In-Stent Restenosis in High-Risk Patients.

Marco Miglionico et.al. – American Journal of Cardiology, December 1, 2015

RESTORE study design

Independent prospective oservational single center
ISR treatment after DES and BMS, 82 patients
In.Pact Falcon, Pantera Lux, Restore

Inclusion Criteria:
> 18 yrs
Stable & unstalbe angina
Or abnormal functional study
Single or multiple restenosis on BMS or DES

Exclusion Criteria:
STEMI patients
Known hypersensitivity or contraindication for prolonged DAPT
High bleeding risk, neoplasm, chronic inflammatory disease, need for non cardiac surgery
No angioagraphic exclusion criteria

Primary endpoints:
Late Lumen Loss at 6 months

Secondary endpoints:
MACE including death, MI andf TLR.

RESTORE results

Patients treated: 48 ISR in BMS,
34 ISR in DES

No statistical significance between DES and BMS group in LLL
LLL in ISR - BMS: 0.25 + 0.35mm
LLL in ISR - DES: 0.22 + 0.30mm;
p= 0.714

No inhospital MACE

restore clinical study graph

Total restenosis incidence
and restenosis incidence per subgroups.

CD- TLR:
In.Pact Falcon: 13.0%
Pantera Lux: 14.3%
Restore: 5.0%

2. LEGFLOW RAPID trial:
Randomized trial of Legflow® Paclitaxel eluting balloon (LPEB) with stentplacement vs standard PTA for the treatment of intermediate (>5cm and <15 cm) and long (>15cm) lesions of the superficial femoral artery (SFA). The RAPID trial.

Jean Paul de Vries et.al. – preliminary results presented at VEITH 2015 and LINC 2016

LEGFLOW study design

Randomized controlled patient-blind multicenter trial
DCB + stent vs PTA + stent
LegFlow + Supera

Inclusion Criteria:
Rutherford 2-6
Symptomatic de novo lesions of the SFA
Lesion length 5-35cm; >15cm
At least one patent below the knee artery with uninterrupted
flow to the pedal arch

Exclusion Criteria:
Contraindications for Anticoagulation (Aspirin, Clopidrogel)
Severe renal failure (e-GFR <30 ml/min/1.73m2)
Acute, acute on chronic limb ischemia

Primary endpoints:
Absence of binary Restenosis at 2 years

Secondary endpoints:
Device, technical and procedural success
Rutherford improvement, Haemodynamic outcome
Re-occlusion Rate
TER, Mortality, Amputation rate

Baseline characteristics

Rutherford 2 – 6 (whereas 85% are claudicants)

Patient characteristics represent real world patients given longest lesion up to 35cm and high occlusion rate.

restore clinical study graph
legflow graph

Summary

• Cardionovum offers a wide clinical program in RCT (randomized clinical trials)
as well as real world patient scenarios

• Cardionovum extends its clinical program continously

• New clinical indications as well as new markets will be covered by dedicated clinical datas