A Randomized Trial of Carotid Artery Stenting With and Without Cerebral Protection

NCT00177346 | Completed

• 2 other identifiers: MakarounIDE0
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate carotid artery stenting (CAS) with and without cerebral protection (CP) to determine if CP improves safety and effectiveness of CAS.

Conditions

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (3)

• Primary Endpoint

• Safety: The 30-day composite of stroke or death,

• Effectiveness: The percentage of subjects who show evidence of new ischemic injury on diffusion MRI imaging, as well as the amount of infarcted tissue

Secondary Outcomes (7)

• Secondary Endpoints

• Successful stent deployment at the target lesion,

• Successful CP device deployment and retrieval,

• Successful resolution of the stenosis (<30% residual stenosis) determined by angiography immediately post-stent placement,

• Access site vascular complications, defined as need for surgical repair or blood transfusion,

Study Arms (2)

CAS with cerebral protection

EXPERIMENTAL

Device: CAS with cerebral protection

CAS without cerebral protection

ACTIVE COMPARATOR

Device: CAS without cerebral protection

Interventions

CAS with cerebral protection DEVICE

CAS with cerebral protection

CAS without cerebral protection DEVICE

CAS without cerebral protection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject (male or non-pregnant female) must be \> 18 years of age.
• The subject should have a stenosis in the common or internal carotid artery of at least 70% determined by one of the modalities listed below.
• The subject should be considered a relatively high risk for carotid endarterectomy. This determination has to be made and documented by two physicians, at least one of who must be a vascular surgeon acting as an investigator on this trial. High risk considerations should include at least one of the following:
• Cardiac dysfunction. NYHA class III or above, compensated or active congestive heart failure (CHF), incomplete coronary revascularization, ejection fraction of \<35%, pulmonary hypertension, or recommendation of a cardiologist against open CEA.
• Pulmonary dysfunction, history of respiratory failure, severe chronic obstructive pulmonary Disease (COPD) on bronchodilators or recommendation of a pulmonary specialist against open CEA.
• Multi-system dysfunction, defined as any combination of medical problems in three distinct systems.
• Anatomic issues: previous CEA or neck dissection, neck irradiation, inaccessible lesions, neck fusion or other anatomic considerations increasing the risk of CEA.
• Age \>80 AND symptomatic (defined below)
• General debilitation documented by the subject's primary physician.
• Increased anesthetic risk as documented by an anesthesiologist.
• Subjects can be either clinically symptomatic or asymptomatic (less than 80 years of age). Symptomatic subjects will have experienced an event within the previous 120 days in the ipsilateral carotid artery distribution. The event will be classified as 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).
• \*\*Patients with major non-hemorrhagic strokes will be included if their clinical status has been stable for 5 days (based on an exam performed by a neurologist participating as a Co-Investigator in this trial).
• If an angiogram is performed to qualify the subject, it should be as recent as feasible and will not be acceptable if done \> 120 days from study entry. Angiograms from other institutions will be acceptable.
• Other non-invasive qualifying imaging modalities include:
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You may not qualify if:

• To participate in this study, the subject may NOT HAVE any of the following at enrollment to the study:
• The subject has had an intracranial hemorrhage, hemorrhagic stroke, or any stroke with mass effect demonstrated on CT scan or MRI within 30 days of the index procedure.
• The subject has a persisting ischemic stroke (defined as either a score \> 15 on the NIH stroke scale, a Rankin score \> 3 or a Barthel score \< 60 measured within one week prior to study entry).
• The subject has an intracranial mass lesion (i.e., abscess, tumor, or other infection).
• The subject has known allergies to heparin, to both ticlopidine and clopidogrel or to metals used in stents.
• There is any visual angiographic evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization.
• The subject has peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding use of catheter-based techniques required for successful results.
• The subject, if female, has a positive pregnancy test.
• The subject has an arterio-venous malformation in the territory of the target carotid artery.
• Subjects with highly calcified lesions resistant to predilation by PTA
• The subject has unstable angina (defined as Class IV or at rest), evolving MI or recent MI (within 14 days).
• The subject has any condition that precludes adequate local hemostasis.
• Patients who are not candidates for MRI scanning (pacemaker, etc).

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center Presbyterian &Shadyside Hospitals

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Michel S Makaroun, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: October 1, 2003
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: January 7, 2016

Record last verified: 2016-01

Locations

US (1)