Clinical Program CARDIONOVUM
| CLINICAL DATA PUBLISHED |
|---|
| CLINICAL EVIDENCE PUBLISHED APERTO® |
| CLINICAL EVIDENCE PUBLISHED LEGFLOW® |
| CLINICAL EVIDENCE PUBLISHED RESTORE® |
| CLINICAL EVIDENCE PUBLISHED XLIMUS® |
| CLINICAL DATA PRESENTED@Congresses |
|---|
| APERTO® |
| LEGFLOW® |
| RESTORE® |
| XLIMUS® |
| ONGOING CLINICAL TRIALS |
|---|
| APERTO® |
| LEGFLOW® |
| RESTORE® |
| XLIMUS® |
Yanqi Yin - Yaxue Shi, et al.,
The American Journal of Kidney Diseases
P19-27.E1, JULY 01, 2021
Efficacy and Safety of Paclitaxel-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Fistulas: A Multicenter Randomized Controlled Trial.
Learn more >>
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.
Learn more >>
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.
Learn more >>
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.
Learn more >>
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
Learn more >>
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.
Learn more >>
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
Learn more >>
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.
Learn more >>Alfonso Ielasi et al., Cardiovascular Revascularization Medicine. In press, Journal Pre-Proof
A Hybrid Approach Evaluating A Drug-Coated Balloon in Combination With A New Generation Drug-Eluting Stent in the Treatment of De Novo Diffuse Coronary Artery Disease: The HYPER Pilot Study
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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,
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,
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.
Learn more >>
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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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
Learn more >>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 1Y
Data presented by dr. Deloose at LINC 2020
View slides >>
REFLOW Study 2Y
Data presented by dr. Bosiers at LINC 2021
View slides >>
RAPID Study
Data presented by dr. van den Heuvel at LINC 2018
View slides >>
| 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 |
| 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 |
| 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 |
| 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 |
