Carotid Endarterectomy vs. Repeated Carotid Angioplasty and Stenting for In-Stent Restenosis (CERCAS)

January 17, 2024 updated by: University Hospital Ostrava

Comparison of Carotid Endarterectomy and Repeated Carotid Percutaneous Transluminal Angioplasty With or Without Stenting for In-stent Restenosis

Patients with in-stent restenosis in carotid artery indicated to carotid intervention will be randomized into repeated carotid percutaneous transluminal angioplasty with or without stenting or carotid endarterectomy with stent removal. The objective of the randomized study is to compare the safety and effectiveness of CEA and CAS in patients with in-stent restenosis of the ICA.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients: Patients with in-stent restenosis in carotid artery indicated to carotid intervention will be randomized into repeated carotid percutaneous transluminal angioplasty with or without stenting or carotid endarterectomy with stent removal.

Repeated carotid percutaneous transluminal angioplasty with or without stenting: Endovascular interventions are going to be performed in local anesthesia from femoral access. Unfractioned heparin (100 IU/kg bodyweight) will be administered in all patients. The procedures will start with diagnostic angiography. Upon verification of severity and morphology of the in-stent stenosis 90 cm long 6F sheath will be introduced into the CCA. The procedures will be performed using distal filter protection. In severe stenoses predilation with 3 or 4 mm diameter balloon will be carried out. In-stent restenoses will be treated preferentially with 5 mm diameter drug eluting balloon. Atropin, up to the dose of 1.0 milligram, can be administered intravenously to prevent serious bradycardia during dilation. Stent will be placed within previous stent in cases of suboptimal PTA result and the decision will be left to the discretion of the interventional specialist. Whenever possible, double-layer technology stent will be used to ensure supreme wall coverage. Distal filter will be removed followed by the completion angiogram including intracranial arteries. Dual antiplatelet therapy (clopidogrel 75 mg/day and acetylsalicylic acid 100 mg/day) will be administered for at least 6 weeks post-procedure. All patients will undergo pre-procedural laboratory testing regarding clopidogrel resistance. In poor responders clopidogrel is going to be replaced by prasugrel or ticagrelor.

Carotid endarterectomy with stent removal: Surgery will be performed in a general or a local anesthesia (decision will be left to the discretion of the operating team) using a cut in front angle of the sternomastoid muscle. Common carotid artery (CCA) and later internal carotid artery (ICA) and external carotid artery (ECA) will be cut free. Common carotid artery, ICA and ECA will be temporarily closed. Using a longitudinal cut of CCA and ICA, stent with an atherosclerotic plaque will be visualized. The stent and a plaque will be withdrawn under the microscopic control and later a suture of arteriotomy will be performed using a monofil non-absorbent fibre 6/0. Just before the end of surgery, hemostatic process will be controlled and drainage will be done. Surgery will be completed by suture of subcutis and cutis. Unfractioned heparin (100 IU/kg bodyweight) could be administered in all patients just before the arteriotomy. In the case of the insufficient collateral flow into middle cerebral artery after clipping of the CCA and ICA, a temporal shunt could be used. Antiplatelet therapy (Aggrenox, clopidogrel 75 mg/day or acetylsalicylic acid 100 mg/day) will be used continuously in all patients.

Clinical examinations: Standard physical and neurologic examinations will be performed before intervention, 24 hours and 30 days after intervention. Evaluation of the neurologic deficit will be performed using the National Institutes of Health Stroke Scale (NIHSS) and modified Rankin scale before, 24 hours and 30 days after intervention.

Randomization: Consecutive patients will be assigned to the carotid endarterctomy with stent removal or repeated carotid percutaneous transluminal angioplasty with or without stenting by a computer-generated 1:1 randomization.

Statistical analysis: All statistical tests will be performed at the Center for Health Research, Faculty of Medicine, University of Ostrava. The normality of distribution of all proceeded data will be checked using the Shapiro-Wilk test. Data with a normal distribution will be reported as the mean ± standard deviation. Parameters not fitting a normal distribution will be presented as the mean, median and interquartile range. Categorical variables in the two arms will be compared by Fisher's exact test. Continuous variables will be compared by the Student's t-test for normally distributed values, or the Mann-Whitney U test. Spearman correlation coefficient and intraclass correlation coefficient will be calculated for the evaluation of interobserver and intraobserver agreements of brain infarction volume measurement. Multiple logistic regression analyses will be used to determine the possible predictors of stroke, TIA, retinal infarction, amaurosis fugax, myocardial infarction or vascular death. All tests will be carried out at an alpha level of significance of 0.05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Czechia
    • Moravskoslezsky Kraj
      • Ostrava, Moravskoslezsky Kraj, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • In-stent restenosis in carotid artery 70 - 99 %
  • Indication to carotid intervention
  • Age 18-80 years
  • Functionally independent with a modified Rankin score value of 0 - 2 points
  • Signed Informed consent

Exclusion Criteria:

  • Contraindication to general anesthesia
  • Contraindication to angiography (iodine allergy, etc.)
  • Technically impossible to perform angioplasty with or without stenting
  • Participation in other clinical study within 60 days
  • Technically impossible to perform carotid endarterectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: carotid endarterectomy
carotid endarterectomy with stent removal
Procedure: Carotid endarterectomy with stent removal
Standard carotid endarterectomy will be extended with the stent removal
Other Names:
  • Carotid endarterectomy
Active Comparator: repeated angioplasty and stenting
percutaneous transluminal angioplasty with or without stenting
Procedure: Carotid endarterectomy with stent removal
Standard carotid endarterectomy will be extended with the stent removal
Other Names:
  • Carotid endarterectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
carotid stenosis
Time Frame: 24 hours
percentage of stenosis in treated carotid artery after intervention
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
vascular morbidity within 30 days
Time Frame: 30 days
ischemic stroke, hemorrhagic stroke, myocardial infarction and/or vascular death
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Ostrava

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tomas Hrbac, MD, PhD, University Hospital Ostrava

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CZ11032017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available at Mendeley

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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