Adapt™ Monorail™ Carotid Stent System: A Postmarket Clinical Follow-up Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 22
- Primary Endpoint
- 30-day rate of major adverse events
Study Overview
Brief Summary
The purpose of this study is to get outcomes data for the Adapt Monorail Carotid System used in conjunction with the FilterWire Embolic protection system for treatment of patients that suffer from carotid artery stenosis and that cannot have surgery due to high risk factors.
Detailed Description
According to the World Health Organization, 15 million people suffer stroke each year. Of these, 5 million die and another 5 million are permanently disabled. Predominant mechanism responsible for stroke is embolism from proximal rupture of atherosclerotic plaque and thrombus. 25-30% of stroke deaths related to the carotid stenosis. The primary therapy for carotid occlusive disease is the surgical removal of this atherosclerotic plaque from inside the artery. Another treatment option for subjects with significant surgical risk factors has been found: the carotid artery stenting is a non-surgical procedure which unblocks narrowing of the carotid artery lumen by inserting a small metal tube (stent) to keep the plaque against the wall of the artery to improve blood flow.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •High-risk for carotid endarterectomy due to anatomical or co-morbid conditions and either has neurological symptoms and ≥ 50% stenosis, via angiography or is asymptomatic and has ≥ 80% stenosis, via angiography
- •Target lesion located in the common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation
- •Arterial segment to be stented has a diameter between 4mm and 9mm
- •Age ≥ 18 years
- •Life expectancy > 12 months from the date of the index procedure
Exclusion Criteria
- •Contraindication to percutaneous transluminal angioplasty (PTA)
- •Severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system
- •Lesions in the ostium of the common carotid artery
- •Occlusion of the target vessel
- •Evidence of intraluminal thrombus
- •Known sensitivity to nickel-titanium
- •Known allergy to heparin, aspirin or other anticoagulant/ antiplatelet therapies, or is unable or unwilling to tolerate such therapies
- •Uncorrectable bleeding disorders, or will refuse blood transfusions
- •History of prior life-threatening contrast media reaction
- •Previous stent placement in the target vessel
- •Evolving stroke or intracranial hemorrhage
- •Previous intracranial hemorrhage or brain surgery within the past 12 months
- •Clinical condition that makes endovascular therapy impossible or hazardous
Arms & Interventions
Adapt Carotid Stent System
Intervention with Adapt Carotid Stent System with the FilterWire EZ System
Intervention: Carotid Artery Stenting (Device)
Outcomes
Primary Outcomes
30-day rate of major adverse events
Time Frame: 30-day postprocedure
30-day rate of major adverse events, defined as the cumulative incidence of any peri-procedural (less or equal to 30 days postprocedure) death, stroke, or Myocardial Infarction
Secondary Outcomes
- Device Malfunctions(from index procedure to 365 days post procedure)
- Late ipsilateral stroke(31 through 365 days post procedure)
- System Technical Success(the procedure time)
- Target Lesion Revascularization(from end of index procedure to 365 days postprocedure)
- In-stent Restenosis(from end of index procedure to 365 days post procedure)
- Major Adverse Events Rate by subgroups(from index procedure to 365 days post procedure)
- Serious device-related and procedure-device related Events(from index procedure to 365 days post procedure)