Clinical trial NCT02102997: Deutsches Dual Therapy Stent Register
Official title: Deutsches Dual Therapy Stent Register
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
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
Lead sponsor: OrbusNeich
Sponsor class: INDUSTRY
First posted: 2014-04-03
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in Germany who have undergone PCI with the COMBO Dual Therapy Stent.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Target Vessel Failure (TVF)
timeFrame: 12 months
Secondary outcomes:
measure: Procedural success
timeFrame: Day of procedure
measure: MACE
timeFrame: 6 weeks and 12 months
measure: Stent induced serious adverse events (SAE)
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 12 months
measure: Thrombolysis in Myocardial Infarction (TIMI) bleeding
timeFrame: 12 months
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Kardiologie Lukaskrankenhaus Neuss
Study officials:
affiliation: Universitätsklinikum Ulm, Klinik für Innere Medizin II Albert-Einstein-Allee 23, 89081 Ulm, Germany
name: Jochen Wöhrle, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kardiologie Lukaskrankenhaus Neuss Preußenstraße 84 D-41464 Neuss, Germany
name: Michael Haude, MD, PhD
role: STUDY_DIRECTOR
affiliation: Klinik für Kardiologie, Zentralklinik Bad Berka GmbH, Robert-Koch-Allee 9 99437 Bad Berka, Germany
name: Bernward Lauer, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kardiologie, Angiologie, Pneumologie, Intensivmedizin Klinikum Fulda gAG Pacelliallee 4 - 36043 Fulda, Germany
name: Volker Schächinger, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.