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TCAR Cerebral Protection And MicroNET-Covered Stent To Reduce Strokes (TOP-GUARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04547387
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
John Paul II Hospital, Krakow

Brief Summary:
Prospective, single center clinical study in consecutive patients with symptoms or signs of carotid stenosis related ischemic cerebral injury undergoing carotid revascularization in primary and secondary stroke prevention. MicroNET-covered stent is implanted using direct carotid artery access and temporary flow reversal to combine optimal intraprocedural cerebral protection and optimal plaque exclusion.

Condition or disease Intervention/treatment
Carotid Artery Diseases Device: Trans-carotid access revascularization with MicroNET covered stent implantation

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Carotid Artery Revascularization Using TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System to Reduce Strokes in Patients With Symptoms or Signs of Cerebral Ischemia: TOP-GUARD Study
Actual Study Start Date : May 10, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Carotid Artery Stenting
Consecutive patients with symptoms or signs of ischemic cerebral injury eligible for endovascular carotid artery revascularization using direct carotid artery access and MicroNET covered carotid stent plaque exclusion under cerebral protection by temporary flow reversal
Device: Trans-carotid access revascularization with MicroNET covered stent implantation
Implantation of the micronet covered self-expanding carotid stent during temporary cerebral flow reversal achieved with direct common carotid artery puncture




Primary Outcome Measures :
  1. Immediate procedural success rate [ Time Frame: 48 hours or hospital discharge, whatever comes first ]
    Combined endpoint of TECHNICAL SUCCESS (insertion and removal of the embolic protection device, successful stent delivery, implantation and delivery system retrieval, with residual stenosis ≤30%) AND CLINICAL SUCCESS (freedom from MACNE (death, stroke, myocardial infarction) up to 48 hrs or hospital discharge)


Secondary Outcome Measures :
  1. Freedom from MACNE up to 30 days [ Time Frame: 30 days postprocedural ]
    Freedom from MACNE (death, ipsi- and contralateral stroke, myocardial infarction)

  2. Freedom from MACNE up to 90 days [ Time Frame: 90 days postprocedural ]
    Freedom from MACNE (death, ipsi- and contralateral stroke, myocardial infarction)

  3. Occurence of new, postprocedural ipsilateral DW-MRI ischemic lesions [ Time Frame: 48 hours post procedure ]
    Occurence of new, postprocedural ipsilateral DW-MRI ischemic lesions (evaluated in 50% of eligible study population)

  4. Occurence of new, postprocedural ipsilateral DW-MRI ischemic lesions [ Time Frame: 90 days post procedure ]
    Occurence of new, postprocedural ipsilateral DW-MRI ischemic lesions (non-contrast evaluation in 50% of eligible study population)

  5. Rate of complete stent expansion and apposition [ Time Frame: During procedure ]
    Complete stent expansion and apposition on IVUS (if performed) in absence of plaque prolapse

  6. Rate of ipsilateral stroke [ Time Frame: 30 days to 1 year post procedure ]
    Rate of ipsilateral stroke

  7. Rate of ipsilateral stroke [ Time Frame: 1 year to 5 years post procedure ]
    Rate of ipsilateral stroke

  8. Rate of any stroke [ Time Frame: Up to 5 years post procedure ]
    Rate of any stroke

  9. Stroke free survival [ Time Frame: Up to 5 years post procedure ]
    Stroke free survival

  10. Ipsilateral stroke free survival [ Time Frame: Up to 5 years post procedure ]
    Ipsilateral stroke free survival

  11. Rate of target vessel restenosis requiring treatment [ Time Frame: Up to 5 years post procedure ]
    Rate of target vessel restenosis requiring treatment

  12. Ultrasound measured Peak Systolic Velocity in target artery [ Time Frame: 48 hours post procedure ]
    Ultrasound measured Peak Systolic Velocity in target artery

  13. Ultrasound measured Peak Systolic Velocity in target artery [ Time Frame: At 30 days post-procedure ]
    Ultrasound measured Peak Systolic Velocity in target artery

  14. Ultrasound measured Peak Systolic Velocity in target artery [ Time Frame: At 1 year post-procedure ]
    Ultrasound measured Peak Systolic Velocity in target artery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All-comer study in consecutive increased-risk patients (defined as those with symptoms or signs of carotid stenosis-related cerebral ischemic injury) eligible for trans-carotid access proximal cerebral protection and MicroNET-covered stent implantation based on the NeuroVascular Team evaluation and agreemment.
Criteria

General Inclusion Criteria:

  • Consecutive adult patients with clinical symptoms and/or signs (on cerebral imaging) of of carotid stenosis-related cerebral ischemic injury eligible for TCAR carotid revascularization according to NeuroVascular Team evaluation and local standards
  • Symptomatic and asymptomatic carotid artery stenosis with ipsilateral ischemic lesions in brain imaging (CT or MRI)
  • Informed written consent
  • Declared compliance and consent to adhere to scheduled follow up and routine long term follow up

Angiographic Inclusion Criteria:

  • De novo or neo-atherosclerotic carotid artery lesion
  • NASCET criteria ≥50% carotid artery stenosis in patients with ipsilateral TIA, stroke or amaurosis fugax within last 6 months
  • NASCET criteria ≥70-80% carotid artery stenosis in asymptomatic patients especially with ipsilateral ischemic lesions in brain imaging (CT or MRI)

General Exclusion Criteria:

  • Lack of technical feasibility or logistic opportunity to perform procedure (device availability)
  • Life expectancy less than 1 year
  • Renal insufficiency with creatinine >3mg/dL
  • Myocardial infarction within last 72 hours before procedure
  • Pregnant women
  • Coagulopathies
  • Allergy to contrast media not amenable to pharmacotherapy

Angiographic Exclusion Criteria:

  • Total carotid artery occlusion
  • Stent in the carotid artery preventing artery cannulation or introduction of stent or protective device
  • Anatomic variants preventing introduction of stent or protective device
  • Significant common carotid artery stenosis proximal to target vessel
  • Moving plaque in aortic arch

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547387


Contacts
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Contact: Piotr Musialek, MD, DPhil +48126142287 pmusialek@szpitaljp2.krakow.pl

Locations
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Poland
Department of Cardiac and Vascular Diseases, John Paul II Hospital Recruiting
Kraków, Maloplska, Poland, 31-202
Contact: Piotr Musialek, Prof    +48126142287    p.musialek@szpitaljp2.krakow.pl   
Sponsors and Collaborators
John Paul II Hospital, Krakow
Investigators
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Principal Investigator: Piotr Musialek, MD, DPhil Department of Cardiac and Vascular Diseases, John Paul II Hospital
Principal Investigator: Mariusz Trystula, MD, PhD Department of Vascular Surgery, John Paul II Hospital
Publications:
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Responsible Party: John Paul II Hospital, Krakow
ClinicalTrials.gov Identifier: NCT04547387    
Other Study ID Numbers: TOP-GUARD
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases