Trial document




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  DRKS00009788

Trial Description

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Title

Bioresorbable vascular scaffolds in ST-elevation myocardial infarction – OCT-guided implantation and mid-term OCT resultsd

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Trial Acronym

DESolve-STEMI-OCT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study is designd to evaluate the security of bioresorbable vascular stents (BRS) in Patient with ST-Segment myocardial Infarction (STEMI). Every Patient with STEMI and BRS is enrolled in the study. Additional the Patients receive an further examination (OCT) to evaluate the success of the Stent-Implantation. Patients receive a further angiography after 4-6 Month with OCT-examination to re-evaluate the success of the Stent-Implantation.

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Brief Summary in Scientific Language

The study is designd to evaluate the security of bioresorbable vascular scaffolds (BRS) in Patient with ST-Segment myocardial Infarction (STEMI). Every Patient with STEMI and BRS is enrolled in the study. Additional the Patients receive an OCT-examination to evaluate the success of the Stent-Implantation. Patients receive a further angiography after 4-6 Month with OCT-examination to re-evaluate the success of the Stent-Implantation.

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Organizational Data

  •   DRKS00009788
  •   2015/12/15
  •   [---]*
  •   yes
  •   Approved
  •   237/15, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

  •   U1111-1177-6518 
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Health Condition or Problem studied

  •   I21 -  Acute myocardial infarction
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Interventions/Observational Groups

  •   STEMI DESolve (bioresorbable vascular scaffolds (BRS) in Patient with ST-Segment myocardial Infarction (STEMI). Every Patient with STEMI and BRS is enrolled in the study. Additional the Patients receive an OCT-examination to evaluate the success of the Stent-Implantation. Patients receive a further angiography after 4-6 Month with OCT-examination to re-evaluate the success of the Stent-Implantation).

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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

device-oriented composite endpoint within 36 Month (target lesion failure [TLF]), defined as the combination of cardiac death, target vessel MI, or clinically driven target lesion revascularisation (TLR), either percutaneous or surgical. Deaths that could not be attributed to another cause were re-garded as cardiac deaths. OCT subgroup: neointima formation after 4-6 month

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Secondary Outcome

-TIMI 0, I, II, III Fluss
-Angina Pectoris
-Successfull Stent-Implantationen
-Target vessel failure (cardiac death, target vessel MI, or clinically driven target vessel revascularisation (TVR), and scaffold thrombosis (ST))
-Kidneyinjury
-Rhythm-Events

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/03/22
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

-All Patients with STEMI and with a anatomically suitable coronarstatus
-Written agreement of the Patient

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Exclusion Criteria

-Intellectual reduction, No suitable coronarstatus (ostial leasion, bifurcation, calc rich leasions)

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Addresses

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    • Universitätsklinikum Bonn
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Krankenhaus der Barmherzigen Brüder Trier
    • Mr.  Dr.  Hauptmann  Felix 
    • Nordallee 1
    • 54292  Trier
    • Germany
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    • Brüderkrankenhaus Trier
    • Mr.  Dr.med  Felix  Hauptmann 
    • Nordalle 1
    • 54292  Trier
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Bonn
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.