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Sponsored by: |
Cordis Corporation |
---|---|
Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00231231 |
The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease during peri-approval/initial commercialization in relation to the outcomes of the Sapphire Clinical Trial. The devices to be utilized are the Cordis PRECISE Nitinol Stent Systems and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).
Condition | Intervention | Phase |
---|---|---|
Carotid Artery Disease |
Device: -PRECISE Nitinol Stent System (5F, 5.5F and 6F) Device: ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patient has a 50% stenosis (as determined by ultrasound or angiogram) of the common or internal carotid artery and is clinically symptomatic; i.e., within the previous 180 days has experienced symptoms in the ipsilateral carotid artery distribution, defined as:
To be entered into the study, the patient must have one or more of the following conditions:
· congestive heart failure (class III/IV) and/or known severe left ventricular dysfunction LVEF < 30%
FEV1 or DLCO 50% of normal. · contralateral carotid occlusion · contralateral laryngeal palsy · post-radiation treatment · previous CEA recurrent stenosis · high cervical ICA lesions · CCA lesions below the clavicle · severe tandem lesions
4. The qualifying ultrasound or angiogram was performed less than 30 days prior to study entry.
· Stenosis >50%: PSV>130 cm/sec; EDV <135 cm/sec
· Stenosis >80%: PSV>220 cm/sec; EDV <135 cm/sec
· PSV ICA/PSV CCA ratio 4.0
5. The target vessel is in the native common or internal carotid artery. The arterial segment to be treated has a diameter between 4 mm and 9 mm as the largest diameter either proximal or distal to the lesion.
Exclusion Criteria:
Study ID Numbers: | P04-5204 |
Study First Received: | September 30, 2005 |
Last Updated: | July 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00231231 |
Health Authority: | United States: Food and Drug Administration |
Embolism Vascular Diseases Central Nervous System Diseases |
Brain Diseases Carotid Artery Diseases Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |