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Low enrolment
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | Successful implantation of the stent and a residual stenosis of less than 20% | Day of procedure |
| MACE | MACE is defined as the composite of of death, myocardial infarction and target lesion revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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All patients in Germany who have undergone PCI with the COMBO Dual Therapy Stent.
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| Name | Affiliation | Role |
|---|---|---|
| Jochen Wöhrle, MD, PhD | Universitätsklinikum Ulm, Klinik für Innere Medizin II Albert-Einstein-Allee 23, 89081 Ulm, Germany | Study Director |
| Michael Haude, MD, PhD | Kardiologie Lukaskrankenhaus Neuss Preußenstraße 84 D-41464 Neuss, Germany | Study Director |
| Bernward Lauer, MD, PhD | Klinik für Kardiologie, Zentralklinik Bad Berka GmbH, Robert-Koch-Allee 9 99437 Bad Berka, Germany | Study Director |
| Volker Schächinger, MD, PhD | Kardiologie, Angiologie, Pneumologie, Intensivmedizin Klinikum Fulda gAG Pacelliallee 4 - 36043 Fulda, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kardiologie Lukaskrankenhaus Neuss | Neuss | D-41464 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23523459 | Background | Haude M, Lee SW, Worthley SG, Silber S, Verheye S, Erbs S, Rosli MA, Botelho R, Meredith I, Sim KH, Stella PR, Tan HC, Whitbourn R, Thambar S, Abizaid A, Koh TH, Den Heijer P, Parise H, Cristea E, Maehara A, Mehran R. The REMEDEE trial: a randomized comparison of a combination sirolimus-eluting endothelial progenitor cell capture stent with a paclitaxel-eluting stent. JACC Cardiovasc Interv. 2013 Apr;6(4):334-43. doi: 10.1016/j.jcin.2012.10.018. Epub 2013 Mar 20. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 6 weeks and 12 months |
| Stent induced serious adverse events (SAE) | 12 months |
| Stent thrombosis | Classified per ARC definitions as definite, probable or possible stent thrombosis | 12 months |
| Thrombolysis in Myocardial Infarction (TIMI) bleeding | Bleeding as defined by the TIMI criteria: major, minor or minimal | 12 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |