Peripheral Arterial Disease
Conditions
Brief summary
The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.
Detailed description
It is a Prospective, multi-center, physician-sponsored clinical study. The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.
Interventions
DEVICERoadSaver stent
lesion treated with RoadSaver stent of Terumo
Sponsors
Flanders Medical Research Program
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. 1. Target lesion located in the distal common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation. 2. Arterial segment to be stented has a diameter between 4mm and 9mm 3. Age ≥ 18 years. 4. Life expectancy \> 12 months from the date of the index procedure. 5. Provides a signed, IRB (Institutional Review Board) / IEC (Institutional Ethical Committee) approved informed consent form prior to participation. 6. Willing and able to comply with follow-up requirements.
Exclusion criteria
1. Contra-indication to percutaneous transluminal angioplasty (PTA). 2. Sever vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system. 3. Lesions in the ostium of the common carotid artery. 4. Occlusion of the target vessel. 5. Evidence of intraluminal thrombus. 6. Known sensitivity to nickel-titanium. 7. Known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies, or is unable or unwilling to tolerate such therapies. 8. Uncorrectable bleeding disorders, or will refuse block transfusion. 9. History of prior life-threatening contrast media reaction. 10. Previous stent placement in the target vessel. 11. Evolving stroke or intracranial haemorrhage. 12. Previous intracranial haemorrhage or brain surgery within the past 12 months. 13. Clinical condition that makes endovascular therapy impossible or hazardous.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day rate of Major Adverse events (MAE) | 30 days | The primary endpoint of this study is the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any peri-procedural (≤ 30 days post-procedure) death, stroke or myocardial infarction (MI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Ipsilateral stroke | day 31 through 365 days | number of patients presenting late ipsilateral stroke within day 31 through 365 days |
| System Technical Success | procedure (day 0) | Defined as the ability to cross and stent the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging. |
| device malfunctions | procedure (day 0) | number of device malfunctions during procedure |
| in-stent restenosis (ISR) | at 1, 6 and 12 month follow-up | patients representing ISR at the different time frames |
| serious device-related and procedure-related Adverse Events (SAE's) | at 1, 6 and 12 month follow-up | number of SAE's at the different time frames |
| freedom from Target Lesion Revascularization (TLR) | at 1, 6 and 12-month follow-up | Defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal an distal to the treated lesion edge. |
| Major Adverse Events (MAE's) | at 1,6 and 12 month follow-up | number of MAE's at the different time frames |
Countries
Belgium
Outcome results
None listed