Clinical Study to Evaluate the Safety and Effectiveness of MER® Stents in Carotid Revascularisation.
NCT ID: NCT03133429
Last Updated: 2019-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2016-10-31
2019-06-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization
NCT04271033
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study
NCT03985774
Registry of Patients With a Bioabsorbable Magnesium Stent Implant MAGMARIS in Usual Clinical Practice
NCT03413813
Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets
NCT06959628
Carotid Artery Stenting With Protection Registry
NCT00318851
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Potential benefit of the MER® stent implantation will be evaluated based on angiography and duplex Doppler ultrasound examination.
Follow ups are scheduled at 30 days, 6 and 12 months after index procedure. Except for clinical follow up patients will undergo carotid vessels ultrasound examination after 6 and 12 months. In case of an emergency visit, caused by the Serious Adverse Event, Patient will undergo: neurological and cardiac evaluation as well as carotid vessels USG examination and extended CT or MRI scans.
In general, all procedures in the study will follow the local standard of care. The type of devices used during the angioplasty (including the MER® stents) will not differ from the devices used in the usual clinical practice in the hospital. DAPT and other medical therapy will be consistent with the rules of the Polish and European Society of Cardiology.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with MER stent
Patients eligible for Carotid Artery Stenting
MER
carotid artery stenting
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MER
carotid artery stenting
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* DS ≥50% (nonsymptomatic patients) and ≤99% based on QCA
* DS ≥75% (symptomatic patients) and ≤99% based on QCA
* Target lesion available for 20-60mm lenght and 4-10mm diameter scaffold
* Patient eligible for CAS
* Age ≥ 18
* Life expentancy ≥ 12 months
* The patient's written informed consent has been obtained prior to the procedure.
Exclusion Criteria
* The patient has experienced an acute myocardial infarction within 72 hours of the procedure
* The patient has known paroxysmal, persistent or permanent atrial fibrillation or flutter
* The patient has known gastrointestinal bleeding
* Pregnancy
* DAPT contraindications
* Surgery planned within 1 month after the procedure
* A platelet count \<100,000/mm³ or \>600,000/mm³
* The patient has known nickel, titanium or contrast allergy
* The target vessel is totally occluded
* The patient has stent(s) in the target lesion
* Statin therapy contraindications
* The target lesion has massive calcifications
* Hyperthyroidism
* Post-radiotherapy side effects
* No pulse in femoral artery
* Chronic kidney disease (creatinine level \>2,0 mg/dl or eGFR\<30 mL/min/1.73 m2 or dialysotherapy)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
KCRI
OTHER
Balton Sp.zo.o.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Piotr Odrowąż-Pieniążek, Prof.
Role: PRINCIPAL_INVESTIGATOR
Oddział Kliniczny Chorób Serca i Naczyń Krakowski Szpital Specjalistyczny im. Jana Pawła II ul. Prądnicka 80 31-202 Kraków
Paweł Buszman, Prof.
Role: PRINCIPAL_INVESTIGATOR
I Oddział Kardiologiczno-Angiologiczny American Heart of Poland S.A. ul. Sanatoryjna 1 43-450 Ustroń
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A., Oddział Chirurgii naczyniowej
Chrzanów, , Poland
Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Uniwersytetu Medycznego w Katowicach, Oddział Chirurgii Ogólnej, Naczyń, Angiologii i Flebologii
Katowice, , Poland
Oddział Kliniczny Chorób Serca i Naczyń Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, , Poland
Centrum Interwencyjnego Leczenia Udaru i Chorób Naczyniowych Mózgu Instytut Psychiatrii i Neurologii
Warsaw, , Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Maciejewski D, Pieniazek P, Tekieli L, Paluszek P, Dzierwa K, Trystula M, Wojcik-Pedziwiatr M, Podolec P. Transradial approach for carotid artery stenting in a patient with severe peripheral arterial disease. Postepy Kardiol Interwencyjnej. 2014;10(1):47-9. doi: 10.5114/pwki.2014.41469. Epub 2014 Mar 23.
Dzierwa K, Pieniazek P, Tekieli L, Musialek P, Przewlocki T, Kablak-Ziembicka A, Kosobucka-Peszat R, Machnik R, Trystula M, Podolec P. Carotid artery stenting according to the "tailored CAS" algorithm performed in the very elderly patients: the thirty day outcome. Catheter Cardiovasc Interv. 2013 Nov 1;82(5):681-8. doi: 10.1002/ccd.25025. Epub 2013 Jul 3.
Pieniazek P, Tekieli L, Musialek P, Kablak Ziembicka A, Przewlocki T, Motyl R, Dzierwa K, Paluszek P, Hlawaty M, Zmudka K, Podolec P. Carotid artery stenting according to the tailored-CAS algorithm is associated with a low complication rate at 30 days: data from the TARGET-CAS study. Kardiol Pol. 2012;70(4):378-86.
Musialek P, Pieniazek P, Tracz W, Tekieli L, Przewlocki T, Kablak-Ziembicka A, Motyl R, Moczulski Z, Stepniewski J, Trystula M, Zajdel W, Roslawiecka A, Zmudka K, Podolec P. Safety of embolic protection device-assisted and unprotected intravascular ultrasound in evaluating carotid artery atherosclerotic lesions. Med Sci Monit. 2012 Feb;18(2):MT7-18. doi: 10.12659/msm.882452.
Dzierwa K, Pieniazek P, Musialek P, Piatek J, Tekieli L, Podolec P, Drwila R, Hlawaty M, Trystula M, Motyl R, Sadowski J. Treatment strategies in severe symptomatic carotid and coronary artery disease. Med Sci Monit. 2011 Aug;17(8):RA191-197. doi: 10.12659/msm.881896.
Pieniazek P. [A new era for the stenting of the carotid arteries in the light of the CREST study]. Kardiol Pol. 2010 Sep;68(9):1086-7. No abstract available. Polish.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MER
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.