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Horst Sievert on behalf of the PERFORMANCE I Study GroupIlona Hofmann, Laura Vaskelyte, Sameer Gafoor, Stefan Bertog, Predrag Matić, Markus Reinartz,
Bojan Jovanovic, Kolja Sievert, Iris Grunwald, Nalan Schnelle
CardioVascular Center Frankfurt - CVC,
Frankfurt, Germany
Interim results from the PERFORMANCE I Study – CAS using a 3-in-1 carotid artery stent system with an integrated
embolic protection filter and post-dilation balloon
LINC 2019Leipzig, Germany, Jan 22-25, 2019
Physician name Company Relationship
Horst Sievert 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin TechnologieGmbH, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed B.V., Contego, CVRx, Dinova, Edwards, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Mokita, Occlutech, pfm Medical, Recor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, Venus, Vivasure Medical
Consulting fees,
Travel expenses,
Study honoraria to institution
Disclosures
Country Principal Investigator Hospital
Bulgaria Ivo Petrov Acibadem City Clinic, Sofia
Italy Alberto Cremonesi (PI) Maria Cecilia Hospital , Cotignola
Italy Eugenio Stabile University of Naples Frederico II, Naples
Germany Dierk Scheinert Universitätsklinikum Leipzig, Leipzig
Germany Ralf Langhoff Sankt Gertrauden Krankenhaus, Berlin
Germany Joachim Schofer Medizinische Versorgungszentrum, Hamburg
Germany Horst Sievert CardioVascular Center CVC, Frankfurt
Macedonia Sasko Kedev University Clinic of Cardiology, Skopje
Slovenia Zoran Milosevic MC Medicor, Izola
PERFORMANCE I STUDY GROUP
The Problem:
• Significant portion of the risk of stroke during CAS occurs due to micro-embolic debris reaching the brain during post-dilation
• Increasing the degree of protection during this phase would be clinically beneficial
• A novel balloon catheter with an integrated filter could help capture micro-emboli and thereby reduce the risk of stroke
The first device that combines an embolic protection filter and balloon
40 micron pore size allows micro-embolic capture
Filter size can be adjusted to suit each patient’s unique anatomy
Integrated Filter:• 40 Micron pores• Baseline closed• Sheathless
Angioplasty Balloon
Catheter
The Solution: Paladin Integrated Embolic Protection (IEP)TM
Using PALADIN, clinical outcome was superior compared to almost all other carotid stenting studies
• Paladin Study:
106 patients
No procedural Stroke
1 unrelated stroke
Low stroke rate
References available for individual study resultsProspective multi-center studies with >100 patients
6.7
8.3
7.2
5.4 5.2
3.9
6.1
10
6.8
2.9 2.8
1.5
2.7
5.2
3.5 3.3
0.90
2
4
6
8
10
12
30-Day MAE defined as death, stroke or MI
2 in 1: PTA balloon
+ embolic protection
3 in 1: Stent + PTA balloon
+ embolic protection
CE M<ark: ✔
US 510(k): ✔
CE Mark: 1Q 2019
US PMA: 2021
Paladin Neuroguard
• 84 Patients undergoing CAS
- ASX – >80% stenosis
- SX - >50% stenosis
• 64 patients enrolled, interim data available for 60 patients at
30 days and 25 patients at 6 months
• Pre-dilation as per operator
• Distal filter mandatory
• Femoral/radial/ulnar access
PERFORMANCE I STUDY INTERIM RESULTS 60 PATIENTS
Baseline Demographics n = 60
Age at time of enrollment, mean SD
(range)
69.1 9.01
(45 – 85)
Male, % (n) 73.3 (44)
BMI, mean (SD) 27.41 4.68
Diabetes mellitus, % (n) 36.7 (22)
COPD, % (n) 18.3 (11)
Renal impairment, % (n) 8.3 (5)
Hyperlipidemia % (n) 80.0 (48)
Hypertension, % (n) 93.3 (56)
Smoking history 63.3 (38)
Previous, % (n) 42.1 (16)
Current, % (n) 57.9 (22)
Prior PVD, % (n) 28.3 (17)
Carotid endarterectomy 1.7 (1)
Percutaneous carotid intervention, contralateral 11.7 (7)
Coronary artery disease 53.3 (32)
Myocardial Infarction 15.0 (9)
Known left ventricular dysfunction (EF < 49%) 1.7 (1)
Hx of TIA or Stroke 18.3 (11)
PERFORMANCE I STUDY
Procedural Details n = 60 %
Procedural Success 100
Primary EPD type, %
Distal embolic protection 98.3
Proximal embolic protection 1.67 (1)
Primary EPD used, %
Emboshield® NAV 6 38.3 (23)
FilterWire EZ ™ 20.0 (12)
Mo.Ma Ultra® 1.67 (1)
SpiderFX® 40.0 (24)
Pre-dilation before Neuroguard placement, % 31.7
Neuroguard Filter successfully deployed, % 100
Neuroguard Stent successfully deployed at target lesion, % 100
Post-dilation with integrated Neuroguard angioplasty balloon, % 100
Dissection % 0
Second stent used in procedure, % 1.67 (n=1)
PERFORMANCE I STUDY
Procedural Success % (n)
Successful Neuroguard carotid stent implantation 100 (60)
50% residual angiographic stenosis as determined by the
angiographic core lab
100 (60)
No device malfunctions 100 (60)
Composite endpoint – Procedure Success 100 (60)
PERFORMANCE I STUDY
PERFORMANCE I STUDY – 30 Day Outcomes, n=60
Primary Endpoint Total
Death 0
Stroke 0
Major 0
Minor 0
Myocardial Infarction* 1 (1.67%)
Total Death/Stroke/MI at 30 days 1 (1.67%)
Total Death/Stroke at 30 days 0
*One patient has a NSTEMI day 17 after CAS, discharged home without complications
PERFORMANCE I STUDY – 6 Month Outcomes, n=25
Primary Endpoint Total
Neurological Death 0
Ipsilateral Stroke 0
Major 0
Minor 0
Total Neurological Death/Ipsilateral Stroke at 6 Months 0
Conclusions• The Neuroguard combines balloon, filter and stent
on one platform
• This reduces the number of procedural steps
• Interim results of 60 patients at 30 days and 25 patients at 6 months show excellent outcomes
Horst Sievert on behalf of the PERFORMANCE I Study GroupIlona Hofmann, Laura Vaskelyte, Sameer Gafoor, Stefan Bertog, Predrag Matić, Markus Reinartz,
Bojan Jovanovic, Kolja Sievert, Iris Grunwald, Nalan Schnelle
CardioVascular Center Frankfurt - CVC,
Frankfurt, Germany
Interim results from the PERFORMANCE I Study – CAS using a 3-in-1 carotid artery stent system with an integrated
embolic protection filter and post-dilation balloon
LINC 2019Leipzig, Germany, Jan 22-25, 2019
