Innovative Application of Pressure Gradient Measurement in Internal Carotid Stenosis in Patients Undergoing CAS

NCT06123767 | Not Yet Recruiting DMC

• 1 other identifier: ABM/2023/01/00001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

About 20% of stroke causes are atherosclerotic strokes caused by carotid artery stenosis. In 2005, 92% of carotid artery interventions in the USA were performed in asymptomatic patients. It should be noted that screening in the general population for carotid artery disease is unwarranted, due to uncertain eligibility criteria for interventional treatment of asymptomatic patients. On the other hand, 10-15% of all patients with a first-ever stroke will experience an ischemic stroke as a result of previously untreated, asymptomatic, significant carotid artery stenosis. Carotid artery angioplasty with stent placement (CAS) has become the second method of revascularization. ed, however, there is a great deal of ambiguity in the application of these criteria, which stems from the ratio of the risk to the possible benefit to the patient of performing the procedure, as well as the cost-effectiveness for health care systems. OBJECTIVES The overall goal is (following the model of measuring fractional flow reserve - FFR) to try to establish a new parameter that could prove helpful in qualifying patients for percutaneous internal carotid artery angioplasty with stent implantation (CAS). Determining whether measuring the pressure gradient across the stenosis will determine which patients will benefit from the CAS procedure. In the absence of convincing evidence on the effects of CAS, especially for so-called asymptomatic patients, it is advisable to establish a parameter that would complement the eligibility criteria that, on the one hand, could prevent strokes in the population of patients with silent internal carotid artery stenosis and, on the other hand, avoid performing the procedure in the absence of benefit. PRIMARY ENDPOINTS:

1. 1.Assessment of cerebral perfusion by magnetic resonanse before and after CAS
2. 2.Assessment of cognitive symptoms using before and after CAS
3. 3.Assessment of neurological symptoms before and after CAS
4. 4.Assessment of otolaryngological symptoms before and after CAS

Conditions

Carotid Artery Stenosis; Carotid Artery Stenting; Stroke

Keywords

CAS (carotid artery stenting); FFR (fractional flow reserve); FFR-CT (Fractional Flow Reserve - Computed Tomography); Carotid Artery Stenosis; Functional assessment of the stenosis; Decision making algorithm

Outcome Measures

Primary Outcomes (13)

• Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on changes in cerebral perfusion after surgery

  Composite endpoint including: Assessment of the predictive capabilities of the obtained pressure gradient values * on changes in cerebral perfusion after surgery (assessment of the cerebral perfusion alterations using DSC (dynamic susceptibility contrast) MR perfusion, before and after CAS

  3 months

• Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on neurological status

  Composite endpoint including: \- changes in neurological status (assesed by the MMSE, mini-mental state examination; NIHSS, National Institutes of Health Stroke Scale),

  12 months

• Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on mental status

  Composite endpoint including: \- changes in cognitive functions (assesed by the MOCA, Montreal Cognitive Assessment - test)

  12 months

• Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on otolaryngological status in hearing functions

  Composite endpoint including: \- changes in hearing functions (assesed by the audiometry, tympanometry and ipsilateral middle ear reflex, otoemission, Skarzynski Tinnitus Scale, ABR - Auditory Brainstem Response, BERA)

  12 months

• Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on otolaryngological status in labyrinth functions

  Composite endpoint including: \- changes in labyrinth functions (assesed by the Skarzynski Tinnitus Scale)

  12 months

• Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on MACEs after surgery

  Composite endpoint including: \- occurence of stroke/TIA or death

  12 months

• Repeatability the diagnostic possibilities of non-invasive tests (Doppler ultrasound) in invasive pressure gradient values

  Composite endpoint including: \- comparison of the obtained invasive pressure gradient values with Doppler ultrasound (PSV, peak systolic velocity; EDV, end-diastolic velocity; estimated degree of stenosis)

  12 months

• Repeatability the diagnostic possibilities of non-invasive tests (CT angiogram) in invasive pressure gradient values

  Composite endpoint including: \- comparison of the obtained invasive pressure gradient values with angio-CT: degree of stenosis

  12 months

• Repeatability the diagnostic possibilities of non-invasive tests ("CT-FFR") in invasive pressure gradient values

  Composite endpoint including: \- comparison of the obtained invasive pressure gradient values with "CT-FFR" (planned creation of an algorithm based on test results: invasive pressure gradient, Doppler ultrasound, angio-CT)

  12 months

• Incidence of Treatment-Related Adverse Events [safety and tolerability] associated with the invasive intravascular pressure measurement procedure (1)

  Composite endpoint including: \- occurrence of periprocedural neurological event: TIA, stroke, death in patients who underwent CAS with the invasive intravascular pressure measurement procedure

  12 months

• Incidence of Treatment-Related Adverse Events [safety and tolerability] associated with the invasive intravascular pressure measurement procedure (2)

  Composite endpoint including: \- occurrence of another periprocedural complication: vascular spasm, perforation, cardiac arrhythmia, hypotonia/hypertension in patients who underwent CAS with the invasive intravascular pressure measurement procedure

  12 months

• Incidence of Treatment-Related Adverse Events [safety and tolerability] associated with the invasive intravascular pressure measurement procedure (3)

  Composite endpoint including: \- occurrence of new hypodense (impact) foci in the head CT scan after the procedure in patients who underwent CAS with the invasive intravascular pressure measurement procedure

  12 months

• Incidence of Treatment-Related Adverse Events [safety and tolerability] associated with the invasive intravascular pressure measurement procedure (4)

  Composite endpoint including: \- changes (improvement or deterioration) in brain perfusion (see point 1.) in the post-operative examination in patients who underwent CAS with the invasive intravascular pressure measurement procedure

  12 months

Secondary Outcomes (1)

• Algorithm angio-CT/non invasive pressure measurement in carotid

  48 months

Study Arms (2)

CAS + Intravascular measuring the pressure gradient

EXPERIMENTAL

Patients with internal carotid stenosis qualified for angioplasty with stent implantation. Standard CAS procedure with additional intravascular pressure measurements

Procedure: CAS + Intravascular measuring the pressure gradient; Procedure: CAS (standard); Diagnostic Test: Doppler ultrasonound of cephalic arteries; Radiation: Angio-CT of the neck and head; Other: Otolaryngological examination; Other: Psychological examination; Other: Neurological examination; Diagnostic Test: MR cerebral perfusion

CAS (standard)

ACTIVE COMPARATOR

Patients with internal carotid stenosis qualified for angioplasty with stent implantation. Standard CAS procedure.

Procedure: CAS (standard); Diagnostic Test: Doppler ultrasonound of cephalic arteries; Radiation: Angio-CT of the neck and head; Other: Otolaryngological examination; Other: Psychological examination; Other: Neurological examination; Diagnostic Test: MR cerebral perfusion

Interventions

CAS + Intravascular measuring the pressure gradient PROCEDURE

Measurements taken during the procedure during CAS * placement of a "FFR"- micro catheter on the neuroprotection wire and taking a measurement before the stenosis and in the internal carotid artery above the stenosis * reading the pressure gradient after obtaining a stable value (a minimum of 5 cardiac cycles) * the study of intravascular pressure measurements will be performed using a special micro catheter

CAS + Intravascular measuring the pressure gradient

CAS (standard) PROCEDURE

Animation of blood pressure measurements on the "FFR" console without actual measurement in carotid artery ("blinding" of the study to the patient) during CAS procedure.

CAS (standard); CAS + Intravascular measuring the pressure gradient

Doppler ultrasonound of cephalic arteries DIAGNOSTIC_TEST

non-invasive assessment of carotid stenosis before surgery and assessment of results after CAS (3 and 12 months after CAS)

CAS (standard); CAS + Intravascular measuring the pressure gradient

Angio-CT of the neck and head RADIATION

Non-invasive pre-operative assessment and post-CAS result (3 months after)

CAS (standard); CAS + Intravascular measuring the pressure gradient

Otolaryngological examination OTHER

Hearing and balance tests (before and after CAS) - prospective follow-up

CAS (standard); CAS + Intravascular measuring the pressure gradient

Psychological examination OTHER

psychological examination with questionnaires (before and after CAS) - prospective follow-up

CAS (standard); CAS + Intravascular measuring the pressure gradient

Neurological examination OTHER

neurological examination with questionnaires (before and after CAS) - prospective follow-up

CAS (standard); CAS + Intravascular measuring the pressure gradient

MR cerebral perfusion DIAGNOSTIC_TEST

Assessment of the cerebral perfusion alterations using DSC (dynamic susceptibility contrast) MR perfusion, before and after CAS (after 3 months): Parametric maps of cerebral blood flow (CBF), cerebral blood volume (CBV), time to peak (TTP), and mean transit time (MTT) will be generated and used for the qualitative and quantitative analyses of the following perfusion parameters: * cerebral blood volume (CBV) value in ml/100ml; * cerebral blood flow (CBF) value in ml/100ml/min; * mean transit time (MTT) value in seconds * time to peak (TTP) value in seconds

CAS (standard); CAS + Intravascular measuring the pressure gradient

Eligibility Criteria

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

You may qualify if:

• Stenosis of the internal carotid artery in symptomatic patients: \> 50%, (confirmed by non-invasive imaging studies: USG, angio-CT), qualified for angioplasty with stent implantation
• Stenosis of the internal carotid artery in asymptomatic patients: \>60%, (confirmed by non-invasive imaging studies: USG, angio-CT), qualified for angioplasty with stent implantation
• Age of patients: \> 18 years of age
• Provided informed consent to participate in the study.

You may not qualify if:

• Inability to obtain informed consent to participate in the study.
• Difficult anatomy of the aortic arch and the descending cephalic arteries (increased atherosclerotic lesions, acute angle of departure of the common carotid arteries, kinking of the internal carotid arteries).

Sponsors & Collaborators

• 4th Military Clinical Hospital with Polyclinic, Poland: lead
• Medical Research Agency, Poland: collaborator

Study Sites (1)

4th Military Hospital

Wroclaw, Lower Silesian Voivodeship, 50-981, Poland

Location

Related Publications (21)

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MeSH Terms

Conditions

Carotid Stenosis; Stroke; Apraxias

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Krzysztof Ściborski, MD, PhD

  4th Military Hospital in Wrocław

  PRINCIPAL INVESTIGATOR

• Waldemar Banasiak, MD, PhD

  4th Military Hospital in Wrocław

  STUDY DIRECTOR

• Artur Telichowski, MD, PhD

  4th Military Clinical Hospital with Polyclinic, Poland

  STUDY DIRECTOR

• Adrian Doroszko, MD, PhD

  4th Military Clinical Hospital with Polyclinic, Poland

  STUDY DIRECTOR

Central Study Contacts

Krzysztof Ściborski, MD, PhD

CONTACT

0048261660452; ksciborski@4wsk.pl

Natalia Świątoniowska-Lonc, MD, PhD

CONTACT

nlonc@4wsk.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The project is a double-blind study. Neither the researchers nor the participants will know what invasive procedures will be performed on a given patient. Patients, investigators, and all persons involved in performing the procedure or analysis of the data, as well as others with an interest in the study results, will remain blinded to the treatment assigned to individual patients from the beginning of the study until the closure of the database. Staff involved in the CAS procedure (with or without blood pressure measurement) will not participate in further patient care and will not provide information to other researchers and people conducting therapy and diagnostics.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Head of Cath Lab; Department of Cardiology, Center for Heart Disease, 4th Military Hospital, Wrocław, Poland

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: November 9, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

PL (1)