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A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Double Filtration During Carotid Artery Stenting Using a Novel Post-Dilation Balloon With Integrated Embolic
Ralf Langhoff1, Joachim Schofer2, Dierk Scheinert3
1Department of Angiology, Sankt Gertrauden Krankenhaus GmbH, Berlin, Germany.
Insights
The Paladin System, a novel angioplasty balloon with an integrated embolic protection filter, demonstrated safety and effectiveness in carotid artery stenting (CAS). It may reduce embolic particles, potentially lowering stroke risk during post-dilation procedures.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Biomedical Engineering
Background:
- Carotid Artery Stenting (CAS) carries risks of major adverse events comparable to carotid endarterectomy.
- Minor stroke risk remains higher with CAS, particularly during post-stent dilation.
- Novel embolic protection strategies are needed to mitigate CAS-related neurological complications.
Purpose of the Study:
- To evaluate the safety and performance of the Paladin System, a new angioplasty balloon with an integrated embolic protection filter.
- To assess the system's ability to provide enhanced embolic protection during post-dilation in CAS procedures.
- To determine the incidence of new ischemic lesions and capture embolic debris.
Main Methods:
- A multi-center study involving 106 patients undergoing CAS in Germany.
- Primary endpoint: 30-day incidence of all-cause death, myocardial infarction, and stroke.
- Secondary assessments included diffusion-weighted MRI for new ischemic lesions and filter analysis for embolic particles.
Main Results:
- 100% device and procedural success rates were achieved.
- The combined major adverse event rate at 30 days was 1.0% (one stroke, deemed unrelated).
- Diffusion-weighted MRI revealed new ischemic lesions in 36.7% of patients; filters captured debris, with 90% of particles <100 μm.
Conclusions:
- The Paladin System appears safe for post-stent dilation in CAS.
- The integrated embolic protection filter may reduce embolic particle load to the brain.
- This technology holds potential for reducing procedure-related stroke risk in CAS.
Objectives:
This study evaluated the safety and performance of the Paladin System, a novel angioplasty balloon with an integrated embolic protection filter designed to increase embolic protection during post-dilation.
Background:
The risk of major adverse events during carotid artery stenting (CAS) is equivalent to carotid endarterectomy. However, the risk of minor stroke remains higher with CAS. Much of this risk occurs during post-stent dilation.
Methods:
A total of 106 patients were enrolled in 5 centers in Germany. The study's primary endpoint was all-cause death, myocardial infarction, and stroke at 30 days post-procedure. Pre- and post-procedural diffusion-weighted magnetic resonance imaging evaluated new ischemic lesions in 30 subjects. Filter histomorphometric analysis was performed in 23 patients. Retrospective analyses compared outcome rates to historical controls.
Results:
Device and procedural success rates were 100%. The combined major adverse event rate (death, myocardial infarction, and stroke) at discharge and at 30 days was 0% and 1.0%, respectively. The single adverse event was a stroke, which occurred at day 12 and was believed unrelated to the device or procedure. New ischemic lesions were found in 11 (36.7%) patients in the diffusion-weighted magnetic resonance imaging subset. New ipsilateral lesions were seen in 9 (30.0%) patients. Mean lesion volume per patient was 0.010 cm3. Debris was present in all filters, and approximately 90% of captured particles were <100 μm.
Conclusions:
Use of the Paladin System for post-stent dilation during CAS appears safe, and it may effectively decrease the number of embolic particles reaching the brain, which may help reduce the risk of procedure-related stroke. (A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection; NCT02501148).
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