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

NCT00178672 | Completed Phase 4 DMC

• 1 other identifier: HSC-MS 01-269 Single Center
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease; Brain Vascular Accident; Carotid Artery Disease; Carotid Stenosis

Keywords

CVA; TIA; Carotid disease; Stroke; Neurology; Carotid Stenting

Outcome Measures

Primary Outcomes (1)

• 30-day composite of major adverse clinical events including death, any stroke, and/or myocardial infarction

  1-30 days

Secondary Outcomes (5)

• successful stent deployment at the target lesion in a variety of carotid morphologies

  30 minutes to 1 hour

• ,successful filter deployment and retrieval

  30 minutes to 1 hour

• ,<30% residual stenosis determined by angiography immediately post-stent placement

  30 minutes to 1 hour

• ,access site vascular complications, such as need for surgical repair or blood transfusion

  30 minutes to 1 hour

• ,patency (< 50% restenosis) of the stent as determined by carotid ultrasound imaging at six (6) months .

  6 months post procedure

Interventions

Angioguard XP distal protection device DEVICE

Standard of care stenting of carotid arteries protocol is used.

Heart Catheterization -Angioplasty PROCEDURE

Standard of care carotid stenting. A catheter is inserted in the femoral vein into the carotid artery where a balloon is inflated and shortly thereafter a stent is placed in the target lesion area.

stenting DEVICE

stenting of carotid arteries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Memorial Hermann Hospital/ Unversity of Texas -HSC Houston

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas Health Science Center web site

MeSH Terms

Conditions

Heart Diseases; Stroke; Carotid Artery Diseases; Carotid Stenosis

Interventions

Stents

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Richard W Smalling, MD,PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: November 1, 2002
• Study Completion: August 1, 2007
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

US (1)