A Single Center of Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease
The primary objective of this study is to assess the safety and effectiveness of stenting in the treatment of obstructive carotid artery disease. Secondary objectives are the assessment and standardization of optimal operator techniques and successful deployment and retrieval of the AngioGuard XP Distal Protection Device. This is a single center, prospective, open-label feasibility study. The study population will consist of patients with atherosclerotic obstructive or post-endarterectomy restenotic lesions in native carotid arteries. The intention is to include patients with both types of lesions.
Brain Vascular Accident
Carotid Artery Disease
Device: Angioguard XP distal protection device
Procedure: Heart Catheterization -Angioplasty
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Single Center IDE Study on Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease|
- 30-day composite of major adverse clinical events including death, any stroke, and/or myocardial infarction [ Time Frame: 1-30 days ] [ Designated as safety issue: Yes ]
- successful stent deployment at the target lesion in a variety of carotid morphologies [ Time Frame: 30 minutes to 1 hour ] [ Designated as safety issue: No ]
- ,successful filter deployment and retrieval [ Time Frame: 30 minutes to 1 hour ] [ Designated as safety issue: Yes ]
- ,<30% residual stenosis determined by angiography immediately post-stent placement [ Time Frame: 30 minutes to 1 hour ] [ Designated as safety issue: Yes ]
- ,access site vascular complications, such as need for surgical repair or blood transfusion [ Time Frame: 30 minutes to 1 hour ] [ Designated as safety issue: Yes ]
- ,patency (< 50% restenosis) of the stent as determined by carotid ultrasound imaging at six (6) months . [ Time Frame: 6 months post procedure ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2002|
|Study Completion Date:||August 2007|
Device: Angioguard XP distal protection device
This study is a single center, prospective, open-label feasibility study evaluating the safety and effectiveness of Carotid Stenting. The study population will include patients with atherosclerotic obstructive lesions and/or post-endarterectomy restenotic obstructive lesions in native carotid arteries. The intention is to include patients with both types of lesions.
At the 30-day, 6-month and 1-year post-procedure clinical visits, the procedures will include a neurological examination and an evaluation of any adverse events. A carotid ultrasound will be performed at 6 months and 1 year after the procedure.
Guidelines for stopping the study will be event rates such as stroke and death that exceed twice the expected frequency of such events treated by surgical endarterectomy techniques. The control rates utilized will be drawn from the NASCET Trial.
Patients who meet all the inclusion criteria and none of the exclusion criteria (as specified in sections 4.1 and 4.2 respectively) will be offered the choice of participating in this study. . Within the inclusion/exclusion criteria are included patients who would otherwise be at high risk for surgical endarterectomy. This would include patients with restenosis after endarterectomy, radical neck dissection, contralateral carotid artery occlusion, and high take-off carotid bifurcation disease. Since 1989, 8000 carotid artery stent procedures have been performed worldwide with a success rate of 98.6%. This procedure combined with the distal protection device, is predicted to show an even greater success rate and a decrease in adverse events for these patients. For these reasons, any patient with significant carotid artery disease felt to be at high risk for surgical correction will be offered the chance to enroll in this registry.
The patients are referred by the stroke team and also by vascular surgery. The potential risks, including recent stroke, excessive cardiopulmonary risk, last remaining patent vessel, etc are all considered as well as the risks of traditional medical or surgical therapy. All treatment options along with possible risks and benefits will be extensively discussed. Cases are reviewed by a multidisciplinary team at a scheduled conference. It is determined at that time whether the patient may be a candidate for carotid stenting. If all criteria are met, then the procedure and study as well as other options will be explained to the patient. An extensive discussion will occur with the patient and family regarding all potential treatment options, risks, and benefits. If the patient wishes to proceed with carotid stenting and be included in the study, an office visit is made with the investigator if not previously done and a possible procedure date is set after the visit with the investigator. At the office visit, the study and informed consent will be explained. All questions will be answered and the patient, if he wishes, will agree to the study by signing the informed consent. The patient and family will be given phone numbers to call for any additional concerns or questions and are repeatedly encouraged to contact us for any arising concerns both before and after the procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178672
|United States, Texas|
|Memorial Hermann Hospital/ Unversity of Texas -HSC Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Richard W Smalling, MD,PhD||The University of Texas Health Science Center, Houston|