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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00177346 |
The primary objective of this study is to evaluate carotid artery stenting (CAS) with and without cerebral protection (CP) to determine if CP improves safety and effectiveness of CAS.
Condition | Intervention |
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Carotid Artery Stenosis |
Procedure: CAS with/without cerebral protection |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial of Carotid Artery Stenting With and Without Cerebral Protection |
Estimated Enrollment: | 100 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | January 2007 |
This study is a single center, prospective, randomized trial evaluating the safety and effectiveness of CAS with and without CP. The study population will be comprised of subjects with atherosclerotic, post endarterectomy restenotic or other obstructive lesions in native carotid arteries. Other carotid artery pathology not amenable to surgical repair (for example carotid artery dissection) will also be considered. Subjects at high risk for complications from standard CEA will be the target population for this study. High risk status will be confirmed by two physicians, one of whom is a vascular surgeon. Both symptomatic and asymptomatic subjects will be enrolled. This will ensure that the proportion of symptomatic subjects is the same in the two arms of the study. “Symptomatic” is defined in the exclusion criteria. The expected duration of this clinical trial is 3 years.
In this study there are there are two arms that a subject may be randomized to:
Group1: CAS with the use of the RX ACCUNET Group 2: CAS without the use of the RX ACCUNET
**This study has been designed to test whether the addition of CP enhances the safety and effectiveness of CAS.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
To participate in this study, the subject MUST have all of the following for inclusion in the study:
• The subject (male or non-pregnant female) must be > 18 years of age.
• The subject should have a stenosis in the common or internal carotid artery of at least 70% determined by one of the modalities listed below.
• The subject should be considered a relatively high risk for carotid endarterectomy. This determination has to be made and documented by two physicians, at least one of who must be a vascular surgeon acting as an investigator on this trial. High risk considerations should include at least one of the following:
Increased anesthetic risk as documented by an anesthesiologist.
Subjects can be either clinically symptomatic or asymptomatic (less than 80 years of age). Symptomatic subjects will have experienced an event within the previous 120 days in the ipsilateral carotid artery distribution. The event will be classified as either 1) one or more TIAs, characterized by distinct focal neurologic dysfunction or monocular blindness with clearing of signs and symptoms within 24 hours, or 2) one or more completed strokes (as defined by this protocol) with persistence of symptoms or signs for more than 24 hours (the most recent event is used as the qualifying event).
**Patients with major non-hemorrhagic strokes will be included if their clinical status has been stable for 5 days (based on an exam performed by a neurologist participating as a Co-Investigator in this trial).
Computed Tomographic Angiography (CTA) performed at UPMC Presbyterian or Shadyside hospitals.
However, if two of the non-invasive studies listed above report a stenosis of >70%, AND the pre-deployment angiogram reveals a 50 –70% stenosis, the patient will be randomized and entered into the trial as the angiogram can on occasion underestimate the stenosis.
Exclusion Criteria:
To participate in this study, the subject may NOT HAVE any of the following at enrollment to the study:
United States, Pennsylvania | |
University of Pittsburgh Medical Center Presbyterian &Shadyside Hospitals | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Michel S Makaroun, M.D. | University of Pittsburgh |
Study ID Numbers: | MakarounIDE, 0 |
Study First Received: | September 12, 2005 |
Last Updated: | March 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00177346 |
Health Authority: | United States: Food and Drug Administration |
Arterial Occlusive Diseases Carotid Stenosis Vascular Diseases Central Nervous System Diseases |
Constriction, Pathologic Brain Diseases Carotid Artery Diseases Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |