Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00178672 |
Other study ID # |
HSC-MS 01-269 Single Center |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
November 2002 |
Est. completion date |
August 2007 |
Study information
Verified date |
November 2020 |
Source |
The University of Texas Health Science Center, Houston |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 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.