Deutsches Dual Therapy Stent Register (DTS Register)

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease

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.

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, D-41464
    • Kardiologie Lukaskrankenhaus Neuss

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients in Germany who have undergone PCI with the COMBO Dual Therapy Stent.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: OrbusNeich
• Investigators: Study Director: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 31, 2014
• First Posted (Estimate): April 3, 2014

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: PCI; Stents; Stent; Multi center; Registry; Sirolimus; Drug eluting stents; Registries; DES; Percutaneous Coronary Intervention (PCI); Drug Eluting Stent (DES); DTS; Drug eluting; Endothelial progenitor cell capturing; Sirolimus eluting; Multi centre; Endothelial Progenitor Cell (EPC)
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: DTS.DE Register V 1.2