Coronary Artery Disease
Conditions
Keywords
DTS, Stents, Stent, DES, Drug eluting, Drug Eluting Stent (DES), Drug eluting stents, Endothelial Progenitor Cell (EPC), Endothelial progenitor cell capturing, Sirolimus, Sirolimus eluting, Percutaneous Coronary Intervention (PCI), PCI, Registry, Registries, Multi center, Multi centre
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
OrbusNeich
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure (TVF) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | Day of procedure | Successful implantation of the stent and a residual stenosis of less than 20% |
| MACE | 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) | 12 months | — |
| Stent thrombosis | 12 months | Classified per ARC definitions as definite, probable or possible stent thrombosis |
| Thrombolysis in Myocardial Infarction (TIMI) bleeding | 12 months | Bleeding as defined by the TIMI criteria: major, minor or minimal |
Countries
Germany
Outcome results
None listed