Trial document




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  DRKS00004540

Trial Description

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Title

Open-Label Post-Marketing Surveillance Study to access safety and efficacy of the “BeGraft Coronary Stent Graft System”

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Open-Label Post-Marketing Surveillance Study to access safety and efficacy of the “BeGraft Coronary Stent Graft System” in the treatment of acute ruptures and perforations as well as aneurysma.

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Brief Summary in Scientific Language

Open-Label Post-Marketing Surveillance Study to access safety and efficacy of the “BeGraft Coronary Stent Graft System” in the treatment of acute ruptures and perforations as well as aneurysma.

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Organizational Data

  •   DRKS00004540
  •   2012/11/29
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  •   no
  •   Approved
  •   5533/12, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   I20-I25 -  Ischaemic heart diseases
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Interventions/Observational Groups

  •   BeGraft Coronary Stent Graft System
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

30 Day Occurrence of MACE:
• Death
• Post procedural target vessel related Q-Wave Myocardial Infarction
• Emergency CABG
• Stent Thrombosis

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Secondary Outcome

Acute Performance Endpoints:
• Successful sealing of acute perforation or rupture of coronary arteries
• Successful treatment of aneurysm of coronary arteries or coronary bypass-vein graft
• Patency (angiographic/visual check);
Angiographic Endpoints at 6-8 Months:
• Binary in-segment restenosis
• Binary In-stent restenosis
• In-stent late lumen loss;
Clinical Endpoints at 12 Months:
• Death
• MI
• Stent Thrombosis
• Target lesion revascularization at 12 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/02/08
  •   30
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1. Patients with acute perforation or rupture of coronary arteries, or
2. Aneurysm of coronary arteries or coronary bypass-vein graft and
3. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study

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Exclusion Criteria

1. Age < 18 years
2. Patients with hemorrhagic diathesis or other disorders in which the application of anticoagulant or antiplatelet therapy is contraindicated and patients unable or unwilling to tolerate anticoagulant / antiplatelet therapy (e.g. septic ulceration, cerebrovascular complications).
3. Patients with known allergies to the used materials: stent material (L605) and/or to the graft material PTFE and/or delivery system (stainless steel) material.
4. Severe allergic reaction to the contrast medium and/or the necessary pharmaceutical treatment (e.g. aspirin) or bleeding complications.
5. Previous enrollment in this trial.
6. Patient’s inability to fully comply with the study protocol.

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Addresses

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    • Firma Bentley InnoMed GmbH
    • Lotzenäckerstr. 25
    • 72379  Hechingen
    • Germany
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    • Deutsches Herzzentrum München
    • Mr.  Dr  Massimiliano  Fusaro 
    • Lazarettstr. 36
    • 80636  München
    • Germany
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    • Deutsches Herzzentrum München
    • Ms.  N.  Rifatov 
    • Lazarettstr. 36
    • 80636  München
    • Germany
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Sources of Monetary or Material Support

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    • Firma Bentley InnoMed GmbH
    • Lotzenäcker 25
    • 72379  Hechingen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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