A Single Center of Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease

Completed · Phase 4

Conditions studied: Heart Disease, Brain Vascular Accident, Carotid Artery Disease, Carotid Stenosis

In brief

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.

Key facts

Study ID

NCT00178672

Run by

The University of Texas Health Science Center, Houston

People needed

69

Starts

2002-11-01

Expected to finish

2007-08-01

Last updated by the study team

2020-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient must be > 18 years of age.
• The patient must be clinically symptomatic, i.e., within the previous 120 days have experienced in the ipsilateral carotid artery distribution, 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). Except as excluded below, the patient must have documented stenosis > 60%, of the common or internal carotid artery. For an asymptomatic patient to be considered, the patient must have a > 70% diameter stenosis of the internal or common carotid artery without neurological symptoms.
• An angiogram is required to qualify the patient, it should be as recent as feasible and will not be acceptable if done > 120 days from study entry.
• An ultrasound will be used as a screening procedure for potential eligible patients and will be performed less than 30 days prior to study entry.
• Stenosis >50%: PSV>130 cm/sec; EDV <135 cm/sec
• Stenosis >80%: PSV>220 cm/sec; EDV ³135 cm/sec
• PSV ICA/PSV CCA ratio ³ 4.011
• The stenosis must be of presumed atherosclerotic origin or secondary to restenosis after previous endarterectomy.
• The target lesion may be in the native common or internal carotid artery
• Temporary cardiac pacing of the patient must be possible, if necessary, along with any necessary hemodynamic support such as vasopressor agents or hemodynamic monitoring.
• Patients taking warfarin may be included if their dosage is reduced before the procedure to result in an INR of 1.5 or less and a Prothrombin Time of 15 seconds. Warfarin may be restarted after the procedure.
• Female patients of childbearing potential must have a documented negative pregnancy test during the index hospitalization because exposure to the radiation and the drugs (antiplatelet agents, anticoagulant agents) given during the cath lab procedure would be potentially harmful to an unborn fetus.
• The patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board or Medical Ethics Committee.

You may not qualify if…

• Candidates will be excluded from the study if ANY of the following conditions apply:
• The patient has had an intracranial hemorrhage, hemorrhagic stroke, major stroke, or any stroke with mass effect demonstrated on CT scan or MRI within four weeks of the index procedure.
• The patient has an intracranial mass lesion
• The patient has an ipsilateral intracranial or extracranial arterial stenosis greater in severity than the treatment lesion.
• The patient has known allergies to heparin, to both ticlopidine and clopidogrel or to metals used in stents.
• The patient has a history of prior life-threatening reaction to the radiocontrast agent.
• The patient has peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding use of catheter-based techniques required for successful results.
• Femoral access is not possible.
• The patient, if female, has a positive pregnancy test
• The patient has any intracranial aneurysm (> 6 mm).
• The patient has an arterio-venous malformation in the territory of the target carotid artery.
• The patient has unstable angina or evolving MI. .
• The patient has a history of bleeding diathesis or coagulopathy.

Where it is running

• Memorial Hermann Hospital/ Unversity of Texas -HSC Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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