Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178672
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2005-09-13
Brief Title:
A Single Center of Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
A Single Center IDE Study on Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 andor 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 41 and 42 respectively will be offered the choice of participating in this study Within the inclusionexclusion 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 986 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
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 41 and 42 respectively will be offered the choice of participating in this study Within the inclusionexclusion 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 986 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None