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Carotid OcclusionNCT02779803

STAMCAR: A Prospective EC-IC Bypass Registry

An observational study of Carotid Occlusion, run by Lahey Clinic at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

A prospective registry evaluating the efficacy of EC-IC bypass in a subgroup of patients, specifically, patients with carotid occlusion and symptoms refractory to medical therapy and evidence for poor cerebrovascular reserve as evaluated by physiological testing (e.g. Diamox Challenge SPECT Scan). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Carotid Occlusion
What is being tested?
EC-IC bypass
Type of treatment
Surgery or procedure
How many people
0 participants
Where
3 sitesUnited States
Study dates
Sep 2016to Dec 2021
How long will I take part?
24 Months
Phase
Observational
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with internal carotid artery or middle cerebral artery occlusion and symptoms refractory to medical therapy and evidence for poor cerebrovascular reserve as evaluated by physiological testing (e.g. Diamox Challenge SPECT Scan).

Who may be able to join

  • Internal carotid artery or middle cerebral artery occlusion
  • Transient ischemic attack (TIA) or ischemic stroke in the ipsilateral hemisphere within 30 days in patients who are either
  • hospitalized unstable patients with crescendo or postural TIA's, OR
  • Multiple TIA's, limb-shaking TIA's, and/or cognitive decline despite medical therapy*
  • Evidence of ipsilateral impaired cerebrovascular reserve on physiological testing (e.g. Diamox challenge SPECT)
  • Modified Rankin Score (mRS) >3
  • Language comprehension intact
  • Age 18-85 years * failure of medical therapy must include at least failure on a regimen of antiplatelets and statins.

Who cannot join

  • Moya-moya syndrome
  • Known heart disease likely to cause cerebral ischemia
  • Prosthetic Valves
  • Atrial Fibrillation
  • Infective endocarditis
  • Left atrial or ventricular thrombus
Show all 16Show fewer
  • Sick sinus syndrome
  • Cardiac myxoma
  • Cardiomyopathy with ejection fraction < 25%
  • Any condition likely to lead to death within 2 years
  • Pregnancy
  • Allergy or contraindication to aspirin
  • Uncontrolled diabetes mellitus (FBS > 300 mg%/16.7 mmol/L)
  • Uncontrolled hypertension (systolic BP>180, diastolic BP >110), other than induced for control of pressure dependent symptoms
  • Uncontrolled hypotension (diastolic BP <65)
  • Unstable angina

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01803

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • University of Miami

    Miami, Florida, 33136

Other trials in United States

About this study

A prospective registry evaluating the efficacy of EC-IC bypass in a subgroup of patients, specifically, patients with carotid occlusion and symptoms refractory to medical therapy and evidence for poor cerebrovascular reserve as evaluated by physiological testing (e.g. Diamox Challenge SPECT Scan). This subgroup includes:

  1. Hospitalized unstable patient with crescendo or postural TIA's
  2. Patients with multiple TIA's, limb-shaking TIA's, and/or cognitive decline despite medical therapy.
Read the detailed description

The registry is a multi-center international prospective registry. The patients will be prospectively followed for 24 months. Enrollment into the registry will take place over 3 years.

The primary objective is to collect prospective data on cerebral revascularization via superficial temporal artery (STA) to middle cerebral artery (MCA) for symptomatic carotid occlusion patients to determine if the procedure can be performed with less than 8% major peri-operative benchmark.

The secondary objective is to determine if cerebral revascularization via STA to MCA bypass will improve cerebral hemodynamics, cognitive function, and quality of life in a defined subgroup of symptomatic carotid occlusion patients over a 2 year period.

Clinical outcome in terms of resolved symptomatology, improved cerebrovascular hemodynamics, and cognitive status will be assessed. Short term and long term follow-up for a period of 24 months will include assessment of ipsilateral stroke or TIA rate, mortality, graft patency, assessment of MCA and bypass flow rates (if available), cognitive evaluation and quality of life evaluation.

Following enrollment baseline demographics and operative data will be collected. Follow-up will be performed at 1 month (m), 3m, 6m, 12m and 24m. Occurrence of new TIA or stroke will be determined. The patient's bypass patency, Qualitative Magnetic Resonance Angiogram (QMRA) flow data (site discretion) and NIHSS Score (NIHSS), Barthel Index (mBARTHEL), modified Rankin Scales (mRANKIN), EuroQOL, and the Montreal Cognitive Assessment (MoCA) with digital Clock Drawing (dCDT) will be recorded. An additional battery of neurocognitive tests will also be administered (Symbol Digit Modalities Test SDMT, Delis-Kaplan Executive Function System D-KEFS and TRAILS A/B).

Being tested
EC-IC bypass

What participants receive

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

  • EC-IC bypassProcedure or surgery

    To determine if cerebral revascularization via STA to MCA bypass to improve cerebral hemodynamics, cognitive function, and quality of life in a defined subgroup of symptomatic carotid occlusion patients.

What is being measured

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

  1. Number of Patients with Ipsilateral Ischemic Stroke

    Measured: During surgery

  2. Number of Patients with Ipsilateral Ischemic Stroke

    Measured: Up to 30 days from surgery

  3. Number of Patients that experience Stroke

    Measured: After 30 days from surgery

  4. Number of Patients that experience Death

    Measured: After 30 days from surgery

Secondary outcomes (11)

  1. Cerebral Hemodynamic Testing

    Steal, Reduced reserve, normal (specific modality to be determined by site)

    Measured: baseline, 3 months, 12 months

  2. Qualitative Magnetic Resonance Angiogram, Non-invasive Optimal Vessel Analysis Blood Flow Data

    Site discretion; test assess the blood flow to the vessels in the brain

    Measured: baseline, 3 months, 12 months

  3. Bypass Patency

    Blood flow remains normal through the bypass

    Measured: 3 months, 6 months, 12 months, 24 months

  4. EuroQOL-5 Dimensions

    A standardized instrument for use as a measure of health outcomes and is applicable to a wide range of health conditions and treatments; provides a simple description profile and a single index value for health status.

    Measured: baseline, 1 month, 3 months, 6 months, 12 months, 24 months

  5. Montreal Cognitive Assessment (MoCA)

    The MoCA was designated as a rapid screening instrument for mild cognitive dysfunction; it assesses difference cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.

    Measured: baseline, 1 month, 3 months, 6 months, 12 months, 24 months

  6. National Institutes of Health Stroke Scale (NIHSS)

    A systematic assessment tool that provides a quantitative measure of stroke-related neurological deficit; used to evaluate acuity of stroke patients, determine appropriate treatment, and predict patient outcomes.

    Measured: baseline, 1 month, 3 months, 6 months, 12 months, 24 months

  7. Modified Rankin Scale (mRankin)

    A 6(0-5) point disability scale that is used widely in both secondary prevention and acute stroke trials, including most of the thrombolysis trials that ranks the patient based upon the disability symptoms

    Measured: baseline, 1 month, 3 months, 6 months, 12 months, 24 months

  8. Modified Barthel Index (mBarthel)

    The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. Can be used to monitor improvement in activities of daily living over time.

    Measured: baseline, 1 month, 3 months, 6 months, 12 months, 24 months

  9. Digital Clock Drawing Test (dCDT)

    The dCDT provides a novel technique to assess both cognitive and motor aspects of psychomotor speed within the same task and the potential to uncover subtleties of behavior not previously detected with non-digitized modes of data collection.

    Measured: baseline, 1 month, 3 months, 6 months, 12 months, 24 months

  10. Delis-Kaplan Executive Function System (D-KEFS)

    the D-KEFS Verbal Fluency Tests comprises of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures the examinee's ability to generate words fluently in an effortful, phonetic format (Letter Fluency), from overlearned concepts (Category Fluency), and while simultaneously shifting between overlearned concepts (Category Switching).

    Measured: baseline, 1 month, 3 months, 6 months, 12 months, 24 months

  11. Reitan Trails A/B Test

    Cognitive Assessment; assess the examinee's ability visual attention and task switching abilities; the trails should be made quickly as possible while trying to avoid mistakes.

    Measured: baseline, 1 month, 3 months, 6 months, 12 months, 24 months

Timeline

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

  1. First posted20 May 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionDec 2021
  4. Study completionDec 2021

Why it stopped: The study team has made the decision to close this study at this time. No patient data was collected and/or analyzed. Since there was no study funds, contracts and budgets were unable to be drafted and sent to participating sites.

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02779803
Sponsor's protocol ID
LCID: 2015-034
Status last verified
Aug 2021
First submitted
12 May 2016
Last updated
4 Mar 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Carotid Occlusion, run by Lahey Clinic at 3 sites 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 8 inclusion and 16 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: withdrawn, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 was withdrawn before enrolling participants, so there are no results.

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?

Number of Patients with Ipsilateral Ischemic Stroke (time frame: During surgery). The study lists 4 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 NCT02779803.

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 4 Mar 2022.

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