NCT03133429

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

April 25, 2017

Last Update Submit

November 18, 2019

Conditions

Carotid Artery Stenosis

Keywords

carotid arterystrokestent

Outcome Measures

Primary Outcomes (1)

  • Stroke within 30 days after the procedure

    Stroke within 30 days after the procedure

    30 days

Secondary Outcomes (5)

  • MAE

    30 days

  • MAE

    365 days

  • Target vessel revascularization within 365 days

    365 days

  • Procedure success

    365 days

  • SADE

    365 days

Study Arms (1)

Patients with MER stent

EXPERIMENTAL

Patients eligible for Carotid Artery Stenting

Device: MER

Interventions

MERDEVICE

carotid artery stenting

Patients with MER stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A., Oddział Chirurgii naczyniowej

Chrzanów, 32-500, Poland

Location

Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Uniwersytetu Medycznego w Katowicach, Oddział Chirurgii Ogólnej, Naczyń, Angiologii i Flebologii

Katowice, 40-635, Poland

Location

Oddział Kliniczny Chorób Serca i Naczyń Krakowski Szpital Specjalistyczny im. Jana Pawła II

Krakow, 31-202, Poland

Location

Centrum Interwencyjnego Leczenia Udaru i Chorób Naczyniowych Mózgu Instytut Psychiatrii i Neurologii

Warsaw, 02-957, Poland

Location

Related Publications (6)

  • 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.

    PMID: 24799929BACKGROUND

  • 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.

    PMID: 23825008BACKGROUND

  • 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.

    PMID: 22528713BACKGROUND

  • 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.

    PMID: 22293887BACKGROUND

  • 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.

    PMID: 21804476BACKGROUND

  • 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.

    PMID: 20859914BACKGROUND

MeSH Terms

Conditions

Carotid StenosisStroke

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2017

First Posted

April 28, 2017

Study Start

October 1, 2016

Primary Completion

June 22, 2017

Study Completion

June 25, 2019

Last Updated

November 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(4)