CARDIONOVUM

The clinical program
of Cardionovum.

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

Clinical Program CARDIONOVUM

clinical program chart

CLINICAL DATA PUBLISHED

APERTO®

CLINICAL EVIDENCE PUBLISHED:

Tozzi M. et al.,
The Journal of Vascular Access 2019; 1-7

Drug-coated balloon angioplasty in failing haemodialysis arteriovenous shunts: 12-month outcomes in 200 patients from the Aperto Italian registry.

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Ierardi AM et al.,
La radiologia medica 2017; 122: 69–76

Usefulness of paclitaxel-releasing highpressure balloon associated with cutting balloon angioplasty for treatment of outflow stenoses of failing hemodialysis arteriovenous shunts.

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LEGFLOW®

CLINICAL EVIDENCE PUBLISHED:

Bosiers M. et al.,
J Cardiovasc Surg (Torino). 2020 Apr 1.

One-year outcome of the paclitaxel-eluting Legflow balloon catheter in the treatment of long and complex femoropopliteal lesions.

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De Boer SW. Et al.,
J Cardiovasc Surg (Torino). 2019 Dec

Drug coated balloon supported Supera stent versus Supera stent in intermediate and long-segment lesions of the superficial femoral artery: 2-year results of the RAPID Trial

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Stabile E. et al.,
Journal of Endovascular Therapy 2019, Vol. 26(1) 26–30

One-Year Clinical Outcomes of the Legflow Drug-Coated Balloon for the Treatment of Femoropopliteal Occlusions Registry.

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Stabile E. et al.,
International Journal of Cardiology 223(2016) 654-655

Interim analysis at 6 months from the LEG-flow Drug Eluting Balloon for the treatment of femoropopliteal occlusions (LEG-DEB) registry

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De Boer S. et al.,
J Endovasc Ther. 2017 Aug 1

Short-term Results of the RAPID Randomized Trial of the Legflow Paclitaxel-Eluting Balloon With Supera Stenting vs Supera Stenting Alone for the Treatment of Intermediate and Long Superficial Femoral Artery Lesions.

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RESTORE®

CLINICAL EVIDENCE PUBLISHED:

Chen Y et al,
JACC Cardiovasc Interv. 2018 Dec 10; 11(23): 2368-2377

Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial,

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Tang Y et al,
JACC Cardiovasc Interv. 2018 Dec 10; 11(23): 2381-2392

Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial,

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Miglionico M. et al.,
Am J Cardiol. 2015 Dec 1;116(11):1690-4.

Efficacy and Safety of Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis in High-Risk Patients.

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Gao L et al.,
J Geriatr Cardiol 2018; 15: 117-122.

Comparison of the safety and efficacy of two types of drug-eluting balloons (RESTORE DEB and SeQuent® Please) in the treatment of coronary in-stent restenosis: study protocol for a randomized controlled trial (RESTORE ISR China)

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XLIMUS®

PUBLISHED CLINICAL EVIDENCE:

Briguori C et al.,
J Interv Cardiol 2016 Dec;29(6): 559-568

Performance of the XLIMUS Sirolimus-Eluting Coronary Stent in Very Complex Lesions

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Briguori C et al.,
Minerva Cardioangiol 2014; 62:1-8

Performance of the XLIMUS sirolimus-eluting coronary stent in very complex lesions

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CLINICAL DATA PRESENTED@Congresses

APERTO®

APERTO Registry

Data presented by prof.Tozzi at LINC 2018 View slides >>

APERTO TRIAL China

Data presented by dr.Qizhuang at LINC 2018 View slides >>

Data presented by dr.Qizhuang at CX 2019 View slides >>

LEGFLOW®

LEGDEB Registry

Data presented by dr. Stabile at LINC 2019
View slides >>

REFLOW Study

Data presented by dr. Deloose at LINC 2020
View slides >>

RAPID Study

Data presented by dr. van den Heuvel at LINC 2018
View slides >>

CLINICAL TRIALS ONGOING

APERTO®

Name Format PI Hospital Subject No. Pts Type NCT Numb Primary Endpoint Publication
APERTO OTW RCT Qizhuang 10 sites in China APERTO OTW vs Balloon Dilatation catheter (OHICHO II) for the treatment of Arteriovenous Fistulae Stenosis in patients undergoing hemodialysis. 160 Multi center NCT02962141 Primary patency rate of the target lesion at 6 months post procedure. Primary patency is defined as freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.0 and freedom from clinically-driven target lesion revascularization (CD-TLR). Restenosis is defined as PSVR> 2.0 determined by independent DUS laboratory. N/A
APERTO REGISTRY Observa-tional Tozzi Varese, Ancona, Torino To demonstrate safety and efficacy of APERTO in a real world scenario 200 Multi center N/A Freedom from restenosis at 1-2-3 year follow up 1) Ierardi AM, Franchin M, Fontana F, Piffaretti G, Duka E, Tonolini M, Miele V, Tozzi M, Carrafiello G. Usefulness of paclitaxel-releasing highpressure balloon associated with cutting balloon angioplasty for treatment of outflow stenoses of failing hemodialysis arteriovenous shunts. La radiologia medica 2017;122:69–76.

2) Drug-coated balloon angioplasty in failing haemodialysis AV shunts: 12-month outcomes in 200 patients from the Aperto Italian registry. J Vasc Access. 2019 Nov, 20(6):733-739

LEGFLOW®

Name Format PI Hospital Subject No. Pts Type NCT Numb Primary Endpoint Publication
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 ISRCTN47846578 Absence of binary restenosis rate. Defined as the percentage of limbs with absence of hemodynamically significant obstruction in the target-lesion after endovascular treatment. 1) Short-term Results of the RAPID Randomized Trial of the Legflow Paclitaxel-Eluting Balloon With Supera Stenting vs Supera Stenting Alone for the Treatment of Intermediate and Long Superficial Femoral Artery Lesions.J Endovasc Ther. 2017 Aug 1;

2) Drug coated balloon supported Supera stent versus Supera stent in intermediate and long-segment lesions of the superficial femoral artery: 2-year results of the RAPID trial. de Boer SW, de Vries JP, Werson DA, Fioole B, Vroegindeweij D, Vos JA, van den Heuvel D; RAPID trial investigators J Cardiovasc Surg (Torino). 2019 Oct 9. doi: 10.23736/S0021-9509.19.11109-3
Magnificent RCT Goverde ZNA Stuivenberg, Antwerp DCB vs POBA-PTA with absence of binary restenosis 138 Multi center NCT02710656 The primary study endpoint is the binary restenosis rate (efficacy). Binary restenosis is defined as a re-obstruction ≥50% of the target lesion (peak systolic velocity ratio > 2.4). Binary restenosis is determined by duplex ultrasonography at 6 and 12 months N/A
REFLOW Observa-tional Bosiers AZ Sinz Blasius, Dendermonde Legflow femopopliteal long lesions vs POBA >15cm Tasc C&D 120 Multi center NCT02580955 Primary patency at 12 months; defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months One-year outcome of the paclitaxel-eluting Legflow balloon catheter in the treatment of long and complex femoropopliteal lesions.Bosiers M, Deloose K, Torsello G, Scheinert D, Verbist J, van den Eynde W, Maene L, Beelen R, Keirse K, Hendriks J, Callaert J, Bosiers M, Wauters J, J Cardiovasc Surg (Torino). 2020 Apr 1.
LEGDEB/LEGDEB2 Observa-tional Stabile TUH Naples, Plovdiv, Antwerp, Sofia Prospective observational study on 400 pts with Legflow 400 Multi center N/A Absence of clinically driven target lesion revascularization (TLR) and binary restenosis (>50%) assessed by angiography or duplex ultrasonography (DUS) if angiography was unavailable 1) Interim analysis at 6 months from the LEG-flow Drug Eluting Balloon for the treatment of femoropopliteal occlusions (LEG-DEB) registry, International Journal of Cardiology 223(2016) 654-655.

2) One-Year Clinical Outcomes of the Legflow Drug-Coated Balloon for the Treatment of Femoropopliteal Occlusions Registry, Journal of Endovascular Therapy 2019
A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW RCT Guo Wei 13 hospitals in China A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW 172 Multi center NCT02965677 Clinically driven target lesion revascularization (CD-TLR) at 12 month post procedure N/A
A Study of Below The Knee Arteries' Stenosis or Occlusion Treated With LEGFLOW OTW RCT Chen Zhong 18 hospitals in China A Study of Below The Knee Arteries' Stenosis or Occlusion Treated With LEGFLOW OTW 172 Multi center NCT02962232 Target lesion restenosis determined by CTA at 6 month post procedure N/A

RESTORE®

Name Format PI Hospital Subject No. Pts Type NCT Numb Primary Endpoint Publication
HYPER Observa-tional Ielasi Istituto S.Ambrogio, ASST Cremona, Brescia S,Anna, Policlinico Casilino Pilot study of hybrid approach DES+DCB in diffuse disease 100 Multi center NCT03939468 DOCE Device Oriented Clinical Endpoint at 12 months N/A
RESTORE SVD RCT Runlin Gao, Master 12 hospitals in China Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease 260 Multi center NCT02946307 In-segment late lumen loss of the target lesion at 9 months Tang et al, Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease The RESTORE SVD China Randomized Trial, J Am Coll Cardiol Intv 2018;11:2381–92
RESTORE ISR RCT Yundai Chen 14 hospitals in China Compare the Efficacy and Safety of RESTORE DEB and SeQuent Please in Chinese Patient With Coronary In-stent Restenosis 240 Multi center NCT02944890 In-segment late lumen loss of the target lesion at 9 months Chen Y et al.Comparison of 2 drug coated balloons in In-stent restenosis-
The RESTORE ISR China Trial,
JACC Cardiovascular Intervention 2018

XLIMUS®

Name Format PI Hospital Subject No. Pts Type NCT Numb Primary Endpoint Publication
XLIMIT: XLIMus drug eluting stent: a randomIzed controlled Trial to assess endothelization RCT Testa Policlinico S.Donato MI, Madrid La Paz, Barcelona San Pau, Barcelona Bellvitge Comparison between XLIMUS DES vs Synergy DES in terms of endothelization measured at OCT 180 Multi center NCT03745053 Strut coverage and in-stent neointimal volume at 6-month follow-up, measured with OCT, following PCI with Xlimus DES or Synergy XLIMIT: XLIMus drug eluting stent: a randomIzed controlled Trial to assess endothelization
L Testa, T, G. Pero, M. Bollati, M. Casenghi, A. Popolo Rubbio, M. Cuman, José Raúl Moreno Gómez, A. Serra, Joan Antoni Gómez, F. Bedogni
International Journal of Cardiology Heart & Vasculature: 2019
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