Safety and Performance Assessment of Drug-Eluting Stent CRE8 in Diabetic Patients

  • STATUS
    Recruiting
  • days left to enroll
    61
  • participants needed
    1200
  • sponsor
    Alvimedica Medical Technologies France
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Updated on 21 April 2019
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Investigator
Anne-Claire Thieulin
Primary Contact
Centre Hospitalier Valence (1.1 mi away) Contact
+20 other location
insulin

Summary

The study is a 'real-world' study which evaluates the safety and performance of the coronary DES-CRE8 in diabetic patients.

As routine care, each patient will be followed until 12 months after stent implantation.

Details
Treatment DES-CRE8
Clinical Study IdentifierNCT03842813
SponsorAlvimedica Medical Technologies France
Last Modified on21 April 2019

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Coronaropathy or NIDDM or Diabetes Mellitus?
years old
patient informed and agreed to participate
patient with one or more lesions treated with one or more coronary stent CRE8
patient with a diabete insulin dependent or non-insulin dependant

Exclusion Criteria

pregnant or breast-feading women
patient who refused to participate
patient with another lesion treated during the same intervention with a balloon alone or with another stent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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