Clinical Study to Evaluate the Safety and Effectiveness of MER® Stents in Carotid Revascularisation. (MER)

Badanie Kliniczne oceniające bezpieczeństwo i skuteczność Stosowania stentów Szyjnych MER® w Rewaskularyzacji tętnic Szyjnych.

The aim of the study is to confirm, whether the MER® stent can be used, without limitations, for the endovascular carotid stenosis treatment in daily clinical practice. Eligible patients will undergo the procedure of the common or internal carotid artery stenting using MER® with proximal or distal neuroprotection.

Study Overview

• Status: Completed
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Device: MER

Detailed Description

MER® stent will be implanted in eligible patients with common and internal carotid stenosis after an informed consent.

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Chrzanow, Poland, 32-500
    • Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A., Oddział Chirurgii naczyniowej
  • Katowice, Poland, 40-635
    • Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Uniwersytetu Medycznego w Katowicach, Oddział Chirurgii Ogólnej, Naczyń, Angiologii i Flebologii
  • Krakow, Poland, 31-202
    • Oddział Kliniczny Chorób Serca i Naczyń Krakowski Szpital Specjalistyczny im. Jana Pawła II
  • Warszawa, Poland, 02-957
    • Centrum Interwencyjnego Leczenia Udaru i Chorób Naczyniowych Mózgu Instytut Psychiatrii i Neurologii

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• De novo lesion located in the internal carotid artery or common carotid artery

  • 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:

• Lack of neurological CAS qualification
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with MER stent; Patients eligible for Carotid Artery Stenting	Device: MER; carotid artery stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke within 30 days after the procedure	Stroke within 30 days after the procedure	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAE	compound Major Adverse Events (death, stroke, heart attack) within 30 days after the procedure	30 days
MAE	compound Major Adverse Events (death, stroke, heart attack) within 365 days after the procedure. Restenosis (%DS ≥50%) within 365 days.	365 days
Target vessel revascularization within 365 days	Target vessel revascularization within 365 days	365 days
Procedure success	Procedure success (with residual stenosis ≤30%)	365 days
SADE	Serious Adverse Device Effect	365 days

Collaborators and Investigators

• Sponsor: Balton Sp.zo.o.
• Collaborators: KCRI
• Investigators: Principal Investigator: Piotr Odrowąż-Pieniążek, Prof., Oddział Kliniczny Chorób Serca i Naczyń Krakowski Szpital Specjalistyczny im. Jana Pawła II ul. Prądnicka 80 31-202 Kraków; Principal Investigator: Paweł Buszman, Prof., I Oddział Kardiologiczno-Angiologiczny American Heart of Poland S.A. ul. Sanatoryjna 1 43-450 Ustroń

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): June 22, 2017
• Study Completion (Actual): June 25, 2019

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: stroke; stent; carotid artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: MER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No