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

Carotid Artery Stenosis Clinical Trial

— MER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133429
• Other study ID #: MER
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: June 25, 2019

Study information

• Verified date: November 2019
• Source: Balton Sp.zo.o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 25, 2019
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Intervention

Device:
• MER
carotid artery stenting

Locations

Country	Name	City	State
Poland	Malopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A., Oddzial Chirurgii naczyniowej	Chrzanow
Poland	Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca Uniwersytetu Medycznego w Katowicach, Oddzial Chirurgii Ogólnej, Naczyn, Angiologii i Flebologii	Katowice
Poland	Oddzial Kliniczny Chorób Serca i Naczyn Krakowski Szpital Specjalistyczny im. Jana Pawla II	Krakow
Poland	Centrum Interwencyjnego Leczenia Udaru i Chorób Naczyniowych Mózgu Instytut Psychiatrii i Neurologii	Warszawa

Sponsors (2)

Lead Sponsor	Collaborator
Balton Sp.zo.o.	KCRI

Country where clinical trial is conducted

Poland, 

References & Publications (6)

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. Review. — View Citation

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. — View Citation

Maciejewski D, Pieniazek P, Tekieli L, Paluszek P, Dzierwa K, Trystula M, Wójcik-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. — View Citation

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. — View Citation

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. — View Citation

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. Polish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke within 30 days after the procedure	Stroke within 30 days after the procedure	30 days
Secondary	MAE	compound Major Adverse Events (death, stroke, heart attack) within 30 days after the procedure	30 days
Secondary	MAE	compound Major Adverse Events (death, stroke, heart attack) within 365 days after the procedure. Restenosis (%DS =50%) within 365 days.	365 days
Secondary	Target vessel revascularization within 365 days	Target vessel revascularization within 365 days	365 days
Secondary	Procedure success	Procedure success (with residual stenosis =30%)	365 days
Secondary	SADE	Serious Adverse Device Effect	365 days