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.
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.
Study Type
OBSERVATIONAL
Enrollment
130
Kardiologie Lukaskrankenhaus Neuss
Neuss, Germany
Target Vessel Failure (TVF)
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).
Time frame: 12 months
Procedural success
Successful implantation of the stent and a residual stenosis of less than 20%
Time frame: Day of procedure
MACE
MACE is defined as the composite of of death, myocardial infarction and target lesion revascularization
Time frame: 6 weeks and 12 months
Stent induced serious adverse events (SAE)
Time frame: 12 months
Stent thrombosis
Classified per ARC definitions as definite, probable or possible stent thrombosis
Time frame: 12 months
Thrombolysis in Myocardial Infarction (TIMI) bleeding
Bleeding as defined by the TIMI criteria: major, minor or minimal
Time frame: 12 months
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