Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007244

Trial Description

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Title

Deutsches Dual Therapy Stent Register

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Trial Acronym

DTS Register

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The DTS.DE registry is an initiative for the collection of high quality process and
historical data of implantations with the COMBO Dual Therapy Stent in Germany. DTS.DE was
designed as a national, non- randomized, prospective, multicenter registry without a
comparison group.

The responsible Steering Committee is of the opinion that the Combo stent qualifies for
further documentation of treatment results in the form of a German registry, based the CE
certification of the COMBO Dual Therapy stent in 2013 and its clinical and scientific
investigation in the context of the REMEDEE study program, as well as company independent
externally initiated studies with the COMBO Dual Therapy Stent.

It is expected that by mid- 2015, at least 1,000 patients will be enrolled and documented in
the DTS.DE registry with the COMBO Dual Therapy Stent. A clinical follow-up is performed
after 6 weeks and 12 months.

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Brief Summary in Scientific Language

It is the objective of the DTS.DE registry to capture the documentation of all patients who
have been treated with a Combo Dual Therapy Stent in Germany, and who have been properly
informed and consented with regards to their participation in the registry. All of these
patients will be registered in the electronic data capturing system (eCRF) of the DTS.DE
registry and will be followed and documented for a period of 12 months.

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Organizational Data

  •   DRKS00007244
  •   2015/04/24
  •   2014/03/24
  •   no
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Secondary IDs

  •   NCT02102997  (ClinicalTrials.gov)
  •   DTS.DE Register V 1.2  (OrbusNeich)
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Health Condition or Problem studied

  •   Coronary Artery Disease
  •   I20-I25 -  Ischaemic heart diseases
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Target Vessel Failure (TVF); time frame: 12 months; TVF is defined as the hierarchical composite of target vessel related Major Adverse Cardiac Events (MACE). MACE is defined as the composite of death, myocardial infarction and target lesion revascularization (TLR).

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Secondary Outcome

- Procedural success; time frame: Day of procedure; Successful implantation of the stent and a residual stenosis of less than 20%
- MACE; time frame: 6 weeks and 12 months; MACE is defined as the composite of of death, myocardial infarction and target lesion revascularization
- Stent induced serious adverse events (SAE); time frame: 12 months
- Stent thrombosis; time frame: 12 months; Classified per ARC definitions as definite, probable or possible stent thrombosis
- Thrombolysis in Myocardial Infarction (TIMI) bleeding; time frame: 12 months; Bleeding as defined by the TIMI criteria: major, minor or minimal

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2013/07/31
  •   1000
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- Patients has at least one coronary lesion, suitable for PCI treatment with the Combo
stent in accordance with European Society of Cardiology Guidelines and local
Guidelines of the Deutsche Gesellschaft für Kardiologie for drug eluting stents

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Exclusion Criteria

- Patient has previously received murine therapeutic antibodies and exhibited
sensitization through the production of Human Anti- Murine Antibodies (HAMA)

- Patient in whom anti-platelet and/or anticoagulant therapy is contraindicated

- Patient in whom a complete inflation of the angioplasty balloon or correct stent
placement is thought to be inhibited

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Addresses

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    • OrbusNeich
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    • Universitätsklinikum Ulm, Klinik für Innere Medizin II Albert-Einstein-Allee 23, 89081 Ulm, Germany
    • Jochen Wöhrle, MD, PhD 
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    • Erdmann Zippel 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.