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

Primary Purpose

Carotid Artery Stenosis

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
MER
Sponsored by
Balton Sp.zo.o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Stenosis focused on measuring carotid artery, stroke, stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with MER stent

Arm Description

Patients eligible for Carotid Artery Stenting

Outcomes

Primary Outcome Measures

Stroke within 30 days after the procedure
Stroke within 30 days after the procedure

Secondary Outcome Measures

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

Full Information

First Posted
April 25, 2017
Last Updated
November 18, 2019
Sponsor
Balton Sp.zo.o.
Collaborators
KCRI
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1. Study Identification

Unique Protocol Identification Number
NCT03133429
Brief Title
Clinical Study to Evaluate the Safety and Effectiveness of MER® Stents in Carotid Revascularisation.
Acronym
MER
Official Title
Badanie Kliniczne oceniające bezpieczeństwo i skuteczność Stosowania stentów Szyjnych MER® w Rewaskularyzacji tętnic Szyjnych.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 22, 2017 (Actual)
Study Completion Date
June 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balton Sp.zo.o.
Collaborators
KCRI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis
Keywords
carotid artery, stroke, stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with MER stent
Arm Type
Experimental
Arm Description
Patients eligible for Carotid Artery Stenting
Intervention Type
Device
Intervention Name(s)
MER
Intervention Description
carotid artery stenting
Primary Outcome Measure Information:
Title
Stroke within 30 days after the procedure
Description
Stroke within 30 days after the procedure
Time Frame
30 days
Secondary Outcome Measure Information:
Title
MAE
Description
compound Major Adverse Events (death, stroke, heart attack) within 30 days after the procedure
Time Frame
30 days
Title
MAE
Description
compound Major Adverse Events (death, stroke, heart attack) within 365 days after the procedure. Restenosis (%DS ≥50%) within 365 days.
Time Frame
365 days
Title
Target vessel revascularization within 365 days
Description
Target vessel revascularization within 365 days
Time Frame
365 days
Title
Procedure success
Description
Procedure success (with residual stenosis ≤30%)
Time Frame
365 days
Title
SADE
Description
Serious Adverse Device Effect
Time Frame
365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Odrowąż-Pieniążek, Prof.
Organizational Affiliation
Oddział Kliniczny Chorób Serca i Naczyń Krakowski Szpital Specjalistyczny im. Jana Pawła II ul. Prądnicka 80 31-202 Kraków
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paweł Buszman, Prof.
Organizational Affiliation
I Oddział Kardiologiczno-Angiologiczny American Heart of Poland S.A. ul. Sanatoryjna 1 43-450 Ustroń
Official's Role
Principal Investigator
Facility Information:
Facility Name
Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A., Oddział Chirurgii naczyniowej
City
Chrzanow
ZIP/Postal Code
32-500
Country
Poland
Facility Name
Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Uniwersytetu Medycznego w Katowicach, Oddział Chirurgii Ogólnej, Naczyń, Angiologii i Flebologii
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Oddział Kliniczny Chorób Serca i Naczyń Krakowski Szpital Specjalistyczny im. Jana Pawła II
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Centrum Interwencyjnego Leczenia Udaru i Chorób Naczyniowych Mózgu Instytut Psychiatrii i Neurologii
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24799929
Citation
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.
Results Reference
background
PubMed Identifier
23825008
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.
Results Reference
background
PubMed Identifier
22528713
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.
Results Reference
background
PubMed Identifier
22293887
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. doi: 10.12659/msm.882452.
Results Reference
background
PubMed Identifier
21804476
Citation
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.
Results Reference
background
PubMed Identifier
20859914
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. No abstract available. Polish.
Results Reference
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Clinical Study to Evaluate the Safety and Effectiveness of MER® Stents in Carotid Revascularisation.

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