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Carotid Artery StenosisMERNCT03133429

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

A study testing MER in people with Carotid Artery Stenosis, run by Balton Sp.zo.o. at 4 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carotid Artery Stenosis
What is being tested?
MER
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesPoland
Study dates
Oct 2016to 25 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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)

Trial locations and contacts

4 sites in 1 country.

Poland4 sites

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

    Chrzanów, 32-500

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

    Katowice, 40-635

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

    Krakow, 31-202

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

    Warsaw, 02-957

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Being tested
MER
Keywords
carotid artery, stroke, stent
Medical subject headings
Carotid Stenosis, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MERDevice

    carotid artery stenting

Study groups in NCT03133429
Study groupRoleWhat they receive
Patients with MER stentExperimentalPatients eligible for Carotid Artery Stenting
Receives: Device: MER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stroke within 30 days after the procedure

    Stroke within 30 days after the procedure

    Measured: 30 days

Secondary outcomes (5)

  1. MAE

    compound Major Adverse Events (death, stroke, heart attack) within 30 days after the procedure

    Measured: 30 days

  2. MAE

    compound Major Adverse Events (death, stroke, heart attack) within 365 days after the procedure. Restenosis (%DS ≥50%) within 365 days.

    Measured: 365 days

  3. Target vessel revascularization within 365 days

    Target vessel revascularization within 365 days

    Measured: 365 days

  4. Procedure success

    Procedure success (with residual stenosis ≤30%)

    Measured: 365 days

  5. SADE

    Serious Adverse Device Effect

    Measured: 365 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2017
  2. Study startOct 2016
  3. Primary completion22 Jun 2017
  4. Study completion25 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03133429
Sponsor's protocol ID
MER
Acronym
MER
Status last verified
Nov 2019
First submitted
25 Apr 2017
Last updated
19 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24799929

  • 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.

    PubMed 23825008

  • 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.

    PubMed 22528713

  • 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.

    PubMed 22293887

  • 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.

    PubMed 21804476

  • 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.

    PubMed 20859914

Questions about this trial

What is this clinical trial studying?

A study testing MER in people with Carotid Artery Stenosis, run by Balton Sp.zo.o. at 4 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke within 30 days after the procedure (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03133429, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.

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