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:

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 2019
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 Status NCT ID Primary Endpoint
APERTO TRIAL RCT Pattynama Groene Hart Hospital, Gouda Aperto vs POBA in AVF 150 Closed for low enrolment NCT02558153 Period until clinical failure of the hemodialysis access after treatment at 6 months. Period of adequate functioning of the hemodialysis access after treatment, defined according to the NKFDOQI protocol criteria.
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 Completed 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
APERTO Registry Observational Tozzi Varese, Italy To demonstrate safety and efficacy of APERTO in a real world scenario 200 Ongoing, 120 patients analysed N/A Freedom from restenosis at 1 year follow up

LEGFLOW®

Name Format PI Hospital Subject No. Pts Status NCT ID Primary Endpoint
RAPID RCT de Vries St. Antonius Nieuwgein DCB vs POBA for pre-dilatation of SFA intermediate and long lesions, followed by stenting 176 Enrollment completed 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.
Magnificent RCT Goverde ZNA Stuivenberg, Antwerp DCB vs POBA-PTA with absence of binary restenosis 138 Enrollment ongoing 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
REFLOW Registry Bosiers AZ Sinz Blasius, Dendermonde Legflow femopopliteal long lesions vs POBA >15cm Tasc C&D 120 Enrollment completed 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
LEG-DEB Registry Stabile TUH Naples, Plovdiv, Antwerp, Sofia Prospective observational study on 400 pts with Legflow 139 Completed 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
A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW RCT Guo Wei Chinese PLA General Hospital DCB vs POBA 172 Enrollment ongoing NCT02965677 Clinically driven target lesion revascularization (CD-TLR) at 12 month post procedure
A Study of Below The Knee Arteries' Stenosis or Occlusion Treated With LEGFLOW OTW RCT Chen Zhong Beijing Anzhen Hospital Capital Medical University DCB vs POBA 172 Enrollment ongoing NCT02962232 Target lesion restenosis determined by CTA at 6 month post procedure

RESTORE®

Name Format PI Hospital Subject No. Pts Status NCT ID Primary Endpoint
RESTORE vs RESOLUTE RCT Runlin Gao, Master Fuwai Hospital, CAMS&PUMC Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease 260 Completed NCT02946307 In-segment diameter stenosis(%) at 9 months
RESTORE vs SEQUENT PLEASE RCT Yundai Chen Chinese PLA General Hospital Compare the Efficacy and Safety of RESTORE DEB and SeQuent Please in Chinese Patient With Coronary In-stent Restenosis 240 Completed NCT02944890 In-segment late lumen loss of the target lesion at 9 months
HYPER Pilot Observational Alfonso Ielasi Istituto Clinico S.Ambrogio To evaluate safety and efficacy at 12 months in pts treated with DES + DCB in long diffuse disease 100 Ongoing NCT03939468 DOCE at 12 months

XLIMUS®

Name Format PI Hospital Subject No. Pts Status NCT ID Primary Endpoint
XLIMIT RCT Luca Testa Policlinico San Donato - Milano Assess angiographic and clinical performance of Xlimus (DES) compared to Synergy Bioabsorbable Polymer Everolimus Eluting Stent in patients treated with percutaneous coronary angioplast 180 Enrollment ongoing NCT03745053 Neointimal volume at 6 months