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Carotid Artery StenosisNCT00177346

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

A study testing CAS with cerebral protection and CAS without cerebral protection in people with Carotid Artery Stenosis, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carotid Artery Stenosis
What is being tested?
CAS with cerebral protection and CAS without cerebral protection
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
Oct 2003to Jan 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • To participate in this study, the subject MUST have all of the following for inclusion in the study:
  • 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.
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  • 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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  • Duplex ultrasound (DU) performed at UPMC Presbyterian or Shadyside hospitals.
  • Magnetic Resonance Angiography (MRA) performed at UPMC Presbyterian or Shadyside hospitals.
  • Computed Tomographic Angiography (CTA) performed at UPMC Presbyterian or Shadyside hospitals.
  • The degree of stenosis from these non-invasive studies has to be confirmed on the pre-deployment diagnostic angiography prior to proceeding with stent deployment.
  • However, if two of the non-invasive studies listed above report a stenosis of >70%, AND the pre-deployment angiogram reveals a 50 -70% stenosis, the patient will be randomized and entered into the trial as the angiogram can on occasion underestimate the stenosis.
  • Female subjects of childbearing potential must have a documented negative pregnancy test during the index hospitalization.
  • The subject 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.
  • If a patient's creatinine is 3.5 or greater, their nephrologist must clear them to participate in the trial.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh Medical Center Presbyterian &Shadyside Hospitals

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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.

Read the detailed description

This study is a single center, prospective, randomized trial evaluating the safety and effectiveness of CAS with and without CP. The study population will be comprised of subjects with atherosclerotic, post endarterectomy restenotic or other obstructive lesions in native carotid arteries. Other carotid artery pathology not amenable to surgical repair (for example carotid artery dissection) will also be considered. Subjects at high risk for complications from standard CEA will be the target population for this study. High risk status will be confirmed by two physicians, one of whom is a vascular surgeon. Both symptomatic and asymptomatic subjects will be enrolled. This will ensure that the proportion of symptomatic subjects is the same in the two arms of the study. "Symptomatic" is defined in the exclusion criteria. The expected duration of this clinical trial is 3 years.

In this study there are there are two arms that a subject may be randomized to:

Group1: CAS with the use of the RX ACCUNET Group 2: CAS without the use of the RX ACCUNET This study has been designed to test whether the addition of CP enhances the safety and effectiveness of CAS.

Being tested
CAS with cerebral protection, CAS without cerebral protection
Medical subject headings
Carotid Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAS with cerebral protectionDevice

  • CAS without cerebral protectionDevice

Study groups in NCT00177346
Study groupRoleWhat they receive
CAS with cerebral protectionExperimentalNot described
Receives: Device: CAS with cerebral protection
CAS without cerebral protectionActive comparatorNot described
Receives: Device: CAS without cerebral protection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoint

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

  3. 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)

  1. Secondary Endpoints

  2. Successful stent deployment at the target lesion,

  3. Successful CP device deployment and retrieval,

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

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

  6. Restenosis (>50% diameter reduction) rates both in-stent or of the adjacent artery determined by carotid ultrasound imaging at 1 year post-procedure,

  7. Ipsilateral neurologic deficits on neurologic assessments at 24 hours and 30 days post-procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startOct 2003
  3. Primary completionJan 2007
  4. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00177346
Sponsor's protocol ID
MakarounIDE
Other IDs
0
Status last verified
Jan 2016
First submitted
12 Sep 2005
Last updated
7 Jan 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing CAS with cerebral protection and CAS without cerebral protection in people with Carotid Artery Stenosis, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00177346.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.

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