TCAR Cerebral Protection And MicroNET-Covered Stent To Reduce Strokes

NCT04547387 | Unknown

• 1 other identifier: TOP-GUARD
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Diseases

Outcome Measures

Primary Outcomes (1)

• Immediate procedural success rate

  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)

  48 hours or hospital discharge, whatever comes first

Secondary Outcomes (14)

• Freedom from MACNE up to 30 days

  30 days postprocedural

• Freedom from MACNE up to 90 days

  90 days postprocedural

• Occurence of new, postprocedural ipsilateral DW-MRI ischemic lesions

  48 hours post procedure

• Occurence of new, postprocedural ipsilateral DW-MRI ischemic lesions

  90 days post procedure

• Rate of complete stent expansion and apposition

  During procedure

Study Arms (1)

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

Interventions

Trans-carotid access revascularization with MicroNET covered stent implantation DEVICE

Implantation of the micronet covered self-expanding carotid stent during temporary cerebral flow reversal achieved with direct common carotid artery puncture

Carotid Artery Stenting

Eligibility Criteria

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

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• John Paul II Hospital, Krakow: lead

Study Sites (1)

Department of Cardiac and Vascular Diseases, John Paul II Hospital

Krakow, Maloplska, 31-202, Poland

RECRUITING

Related Publications (7)

• Yee EJ, Wang SK, Timsina LR, Ruiz-Herrera S, Liao JL, Donde NN, Fajardo AC, Motaganahalli RL. Propensity-Matched Outcomes of Transcarotid Artery Revascularization Versus Carotid Endarterectomy. J Surg Res. 2020 Aug;252:22-29. doi: 10.1016/j.jss.2019.12.003. Epub 2020 Mar 26.

  PMID: 32222590 BACKGROUND

• Musialek P, Mazurek A, Trystula M, Borratynska A, Lesniak-Sobelga A, Urbanczyk M, Banys RP, Brzychczy A, Zajdel W, Partyka L, Zmudka K, Podolec P. Novel PARADIGM in carotid revascularisation: Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard MicroNet-covered embolic prevention stent system. EuroIntervention. 2016 Aug 5;12(5):e658-70. doi: 10.4244/EIJY16M05_02.

  PMID: 27180302 BACKGROUND

• Mazurek A, Borratynska A, Malinowski KP, Brozda M, Gancarczyk U, Dluzniewska N, Czyz L, Duplicka M, Sobieraj E, Trystula M, Drazkiewicz T, Podolec P, Musialek P. MicroNET-covered stents for embolic prevention in patients undergoing carotid revascularisation: twelve-month outcomes from the PARADIGM study. EuroIntervention. 2020 Dec 4;16(11):e950-e952. doi: 10.4244/EIJ-D-19-01014. No abstract available.

  PMID: 32482614 BACKGROUND

• Chang DW, Schubart PJ, Veith FJ, Zarins CK. A new approach to carotid angioplasty and stenting with transcervical occlusion and protective shunting: Why it may be a better carotid artery intervention. J Vasc Surg. 2004 May;39(5):994-1002. doi: 10.1016/j.jvs.2004.01.045.

  PMID: 15111851 BACKGROUND

• Criado E, Fontcuberta J, Orgaz A, Flores A, Doblas M. Transcervical carotid stenting with carotid artery flow reversal: 3-year follow-up of 103 stents. J Vasc Surg. 2007 Nov;46(5):864-9. doi: 10.1016/j.jvs.2007.07.028.

  PMID: 17980271 BACKGROUND

• Pipinos II, Johanning JM, Pham CN, Soundararajan K, Lynch TG. Transcervical approach with protective flow reversal for carotid angioplasty and stenting. J Endovasc Ther. 2005 Aug;12(4):446-53. doi: 10.1583/05-1561.1.

  PMID: 16048376 BACKGROUND

• Trystula M, VAN Herzeele I, Kolvenbach R, Tekieli L, Fonteyne C, Mazurek A, Dzierwa K, Chmiel J, Lindsay J, Kwiatkowski T, Hydzik A, Oplawski M, Bederski K, Musialek P. Next-generation transcarotid artery revascularization: TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System To Reduce Strokes - TOPGUARD Study. J Cardiovasc Surg (Torino). 2024 Jun;65(3):181-194. doi: 10.23736/S0021-9509.24.13121-7.

  PMID: 39007552 DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Musialek, MD, DPhil

CONTACT

+48126142287; pmusialek@szpitaljp2.krakow.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 14, 2020
• Study Start: May 10, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)