- Trial ID:
- Curtiss Stinis
- 1. Subject must be ≥ 18 years of age.
- 2. Subject does not have any condition that limits their anticipated survival to less than 3 years.
- 3. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure.
- 4. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR-
- 5. Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram.
- 6. Subject with all the following target vessel characteristics:
- 1. Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
- 2. Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery.
- 3. Absence of excessive vessel tortuosity that would impede delivery of devices.
- 7. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure.
- 1. Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA).
- 2. Subject with Hgb , 10.g/dl or platelet count < 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an INR > 1.5.
- 3. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions.
- 4. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such.
- 5. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- 6. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Why isn't this trial accepting new patients?
The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting
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How can I find trials that are accepting new participants?
For more information, see a list of trials that are recruiting, or call the clinical research office at 800-995-4200 for help.