on behalf of the luminor collaborators · v. riambau, md. phd, on behalf of the luminor...
TRANSCRIPT
![Page 1: on behalf of the LUMINOR collaborators · V. Riambau, MD. PhD, on behalf of the LUMINOR collaborators Prof. and Chief of Vascular Surgery Division, ... 6- H. Asturias Dr. Manuel Alonso](https://reader034.vdocuments.us/reader034/viewer/2022051321/5ac59a387f8b9a333d8df537/html5/thumbnails/1.jpg)
V. Riambau, MD. PhD,
on behalf of the LUMINOR collaborators
Prof. and Chief of Vascular Surgery Division,
Cardiovascular Institute, Hospital Clínic of Barcelona
University of Barcelona
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Consultant/Advisor/Research •Aptus Endosystems
•Bolton Medical
•Cordis
•Medtronic
•iVascular
•Bayer
•MSD
•Ferrer
•GE
•ASTA ZENEKA
•W.L. Gore
•Jotec
Proctor•Bolton Medical
•Cook
•Medtronic
•W.L. Gore
•Aptus
•Cordis
•Jotec
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•Background
•Material and Methods
•Results
• Summary
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•Background
•Material and Methods
•Results
• Summary
![Page 5: on behalf of the LUMINOR collaborators · V. Riambau, MD. PhD, on behalf of the LUMINOR collaborators Prof. and Chief of Vascular Surgery Division, ... 6- H. Asturias Dr. Manuel Alonso](https://reader034.vdocuments.us/reader034/viewer/2022051321/5ac59a387f8b9a333d8df537/html5/thumbnails/5.jpg)
1• Long tip with high
crossing capability
2
• Good shape
• Short Shoulders
3• Quick deflation time
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1
• PTX microcrystalline structure
• Dosage: 3 μg/mm2
2
• Excipient: Water Reduced Ester
• Drug/excipient ratio: 80/20
3
• Transfertech® Coating technology. Multilayer, Uniform nanodrops by ultrasonic spray
SEM: magnify: x250
SEM: magnify: x 1000
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•Background
•Material and Methods
•Results
• Summary
![Page 8: on behalf of the LUMINOR collaborators · V. Riambau, MD. PhD, on behalf of the LUMINOR collaborators Prof. and Chief of Vascular Surgery Division, ... 6- H. Asturias Dr. Manuel Alonso](https://reader034.vdocuments.us/reader034/viewer/2022051321/5ac59a387f8b9a333d8df537/html5/thumbnails/8.jpg)
Luminor Registry is an observational, prospective, multicenter study with single-arm treatment forstenotic or occlusive lesions or in-stent stenosis of the femoro-popliteal (FP) and below the knee (BTK)vessels. Clinical trials.gov identifier: NCT02458911
PRIMARY ENDPOINTSTo analyse the performance of Luminor 14 and 35 in terms of primary patency, defined as freedomfrom >50% restenosis as indicated by duplex ultrasound peak systolic velocity ratio (PSVR) <3 in thetarget vessel with no re-intervention, and freedom of serious adverse events defined as death,amputation and TLR during a minimum of 12-month follow-up period.
SECONDARY ENDPOINTSInclude quality of life assessment and other clinical or hemodynamic complications.
L U M I N O R r e g i s t r y
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L U M I N O R r e g i s t r y
• A total of 207 validated Rutherford 2-5 cases have been recruited during a
15-month period following an intention to treat basis.
• All the procedures have followed the instructions for use.
• Primary stenting or atherectomy were excluded.
• Adjuvant drug treatment was applied for all patients [Clopidogrel 75
mgr/day + ASA 100 mgr/day (one month) and ASA 100 mgr/day (indefinite)].
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L U M I N O R r e g i s t r y : C L I s u b g r o u p
Demographics N %
Patients with CLI 148
Male 101 68.2
Age (years) 73.2±11.4
Diabetes 106 71.6
Smoking and ex-smoking 80 54.0
Arterial Hypertension 129 87.2
Hyperlipidemia 85 57.4
Chronic Renal Failure (stage ≥3) 44 29.7
Rutherford Class
4 24 16.2
5 124 83.8
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Lesion characteristics
Lesions (n) 180
Lesion length (mm) 77.4±50.3
Chronic Total Occlusions–CTO (%) 53.9
Stenosis (%) 46.1
BTK (%) 48.9
Severe calcification (%) 56.7
L U M I N O R r e g i s t r y : C L I s u b g r o u p
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•Background
•Material and Methods
•Results
• Summary
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L U M I N O R r e g i s t r y : C L I s u b g r o u p
30-Days follow-up
All-cause mortality 3.4%
Major amputations 2.0%
TLR 1.7%
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L U M I N O R r e g i s t r y : C L I s u b g r o u p
87.7%
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L U M I N O R r e g i s t r y : C L I s u b g r o u p
85.1%
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L U M I N O R r e g i s t r y : C L I s u b g r o u p
84.7%
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L U M I N O R r e g i s t r y : C L I s u b g r o u p
92.1%
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L U M I N O R r e g i s t r y : BT K s u b g r o u p
85.9%
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L U M I N O R r e g i s t r y : BT K s u b g r o u p
88.2%
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L U M I N O R r e g i s t r y : BT K s u b g r o u p
79.0%
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L U M I N O R r e g i s t r y : BT K s u b g r o u p
89.6%
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•Background
•Material and Methods
•Results
• Summary
![Page 23: on behalf of the LUMINOR collaborators · V. Riambau, MD. PhD, on behalf of the LUMINOR collaborators Prof. and Chief of Vascular Surgery Division, ... 6- H. Asturias Dr. Manuel Alonso](https://reader034.vdocuments.us/reader034/viewer/2022051321/5ac59a387f8b9a333d8df537/html5/thumbnails/23.jpg)
• REAL WORLD experience with LUMIMOR DCB is highlypositive in terms of safety and effectiveness even in patientswith a very poor clinical and anatomical conditions
L U M I N O R
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L U M I N O R r e g i s t r y
Hospital PI Collaborator 1 Collaborator 2
1- H. Getafe Dr Francisco Acín Dra. Cristina Cañibano Domínguez Dr. Ignacio Michel Guisasola
2- H. La Paz Dr. Luis Riera del Moral
3- H. Clínic Dr. Vicente Riambau Dr. Xavier Yugueros Dr. Gaspar Mestres
4- H. Parc Taulí Dr. Antonio Giménez Gaibar Dra. Sara Rioja Artal Dra. Elena González Cañas.
5- H. Ourense Dr. Nilo Mosquera Arochena Dr Ignacio García Fernández Dra Rebeca Vazquez Dopazo
6- H. Asturias Dr. Manuel Alonso Dra. Carol Padron Encalada
7- H. Burgos Dr. Francisco Medina Dr. Ignacio Agúndez Gómez Dra. Monica Herrero Bernabé
8- H. Basurto Dra Reyes Vega Dr. Ricardo Asensio Garcia Dra. Esther Bravo Ruiz
9- H. Donostia Dr. Mariano Juan de Blas Bravo Dra. Ainhoa Garcia Dr. Jose María Egaña
10- H. Cruces Dr. Juan Luis Fonseca Legrand Dra. Ana Apodaka Dra. Ederi Mikelarena Monteiro
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V. Riambau, MD. PhD,
on behalf of the LUMINOR collaborators
Prof. and Chief of Vascular Surgery Division,
Cardiovascular Institute, Hospital Clínic of Barcelona
University of Barcelona