regeneration trial. clinical evaluation of the new … · regeneration trial. clinical evaluation...
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REGENERATION trial. Clinical evaluation of the
new Relay PRO and
RELAY NBS PRO stent-grafts in TEVAR
Fabio Verzini, MD, PhD, FEBVS for The Re-Generation trial Participants
Prospective, multicentre, European investigational study to evaluate acute results (operative to 30-day) of the new Relay PRO Thoracic Endografts
Re-Generation Trial: definition
30 subjects
8 sites 3 to 5 subjects / site (estimated)
2 countries
1-month follow up
10 patients minimum will be treated with Relay PRO or Relay NBS PRO
Participating Sites
SPAIN: V. Riambau (P.I.) ! Hospital Clinic Barcelona I. García ! Hospital M. Valdecilla (Santander) S. Llagostera / C. Esteban ! Hosp. G. Trias (Badalona) J. Maeso ! Hospital Vall Hebrón (Barcelona)
ITALY: R. Giudice ! Ospedale San Giovanni Roma G. Fadda ! Ospedale S. Francesco, Nuoro P. Trabattoni ! Centro Cardiologico Monzino (Milano) M. Lenti / F. Verzini ! Az. Ospedaliera & University of Perugia
Primary Endpoints • Freedom from Aortic-related mortality • Delivery and deployment success evaluation:
o Delivery system evaluation o Overall rate of vascular access complications (≤30 days) o Rate of access failures o Rate of deployment system difficulties
Secondary Endpoint • Freedom from major device-related adverse events [endoleak
(Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aorta rupture, deployment failure, and conversion to surgical repair at 30 days
Inclusion / Esclusion Criteria ! According to the IFU of current RELAY plus and RELAY NBS plus
Stent Graft improvements
Delivery device improvements
Reduction of 3 to 4 F for each diameter
17
18
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20
21
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25
26
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22 24 26 28 30 32 34 36 38 40 42 44 46
Fren
ch s
ize
(OD
)
New Profile distribution
Material improvements contributing to profile reduction
Engineered Graft Material
Graft fabric will change to an engineered textile to reduce profile
Delivering 47% profile reduction
Optimized Radiopaque
Markers position
Improved Primary Sheath
design
Reviewed Secondary Sheath
material
Thin wall coiled primary introducer sheath
Delivering 11% profile reduction
Reduction of secondary sheath diameter:
" Relay Pro: 9.0mm
and wall thickness: " Relay Pro: 0.0025”
Delivering 28% profile reduction
Profile reduction
PATIENT POPULATION N %
Gender distribution
Male 18 78
Female 5 22
TOTAL
23 100.0
Age at operation (years) Mean (range) 7.8 (39 - 86)
Clinical results
THORACIC AORTA LESIONS TREATED
N % Atherosclerotic aneurysm 19 84 Chronic 17 Ruptured 1 TAA + PAU 1
N % Dissection 4 10.5 TAD + PAU
2
Not reported
1 5.5
Lesion diameter (mean) 56.0 mm
Clinical results
OPERATIVE DATA N %
Number of stents used
1 device 17 73.9
2 devices 5 21.7
3 devices 1 4.4
Total stents used 30
Relay PRO vs. Relay NBS PRO
12/18 40/60
Mean units/patient 1.3 OPERATIVE DATA
N %
Intended Landing zone Z0 1 4.3 Z1 2 8.8 Z2 5 21.7 Z3 5 21.7 Z4 10 43.5
Aortic arch 56.5%
OPERATIVE DATA
Mean access diameter (mm)
8.8
Induced hypotension
16 (69%)
Technical success
22 (95.6%)
Complications 3* (13.0%)
* 1 Endoleak Type I a + Device did not deploy at the target zone (hypotension not used) 1 Stroke (unlikely device-related. Previous debranching of SAT) 1 Stent-graft migration during deployment (windsock effect)
Clinical results
OUTCOMES AT DISCHARGE
Hospital stay (days) Mean (range) 4.0 (1 - 13) ICU stay (hours) Mean (range) 18.8 (0-104)
N % Mortality Early (≤30 days) or operative deaths 0 0
Clinical results
FU DATA (n = 16)
Normal findings
15
Abnormal findings
1 Small Type Ia endoleak
Conversion to Open Surgery
0
SAEs
1 SAE (Stroke)
Clinical results
Case 1
Preoperative Post operative
Case 2
Preoperative Post operative
Conclusions
# Relay PRO and Relay NBS PRO represent the newest improvements in Relay family products
# Refinements have been designed both in the delivery device and in the stent-graft
# Clinical evaluation is close to be completed by REGENERATION European trial
# Product is expected to be available before the end this year
# Clinical results demonstrate the high performance of the product in regards navigability, accuracy, conformability and safety
# REGENERATION trial confirms that the new Relay PRO and Relay NBS PRO are leading edge all-round devices in TEVAR
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Thank you
REGENERATION trial. Clinical evaluation of the
new Relay PRO and
RELAY NBS PRO stent-grafts in TEVAR
Fabio Verzini, MD, PhD, FEBVS for The Re-Generation trial Participants