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Deutsches Dual Therapy Stent Register

NCT ID: NCT02102997

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Keywords

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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

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OrbusNeich

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jochen Wöhrle, MD, PhD

Role: STUDY_DIRECTOR

Universitätsklinikum Ulm, Klinik für Innere Medizin II Albert-Einstein-Allee 23, 89081 Ulm, Germany

Michael Haude, MD, PhD

Role: STUDY_DIRECTOR

Kardiologie Lukaskrankenhaus Neuss Preußenstraße 84 D-41464 Neuss, Germany

Bernward Lauer, MD, PhD

Role: STUDY_DIRECTOR

Klinik für Kardiologie, Zentralklinik Bad Berka GmbH, Robert-Koch-Allee 9 99437 Bad Berka, Germany

Volker Schächinger, MD, PhD

Role: STUDY_DIRECTOR

Kardiologie, Angiologie, Pneumologie, Intensivmedizin Klinikum Fulda gAG Pacelliallee 4 - 36043 Fulda, Germany

Locations

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Kardiologie Lukaskrankenhaus Neuss

Neuss, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 23523459 (View on PubMed)

Other Identifiers

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DTS.DE Register V 1.2

Identifier Type: -

Identifier Source: org_study_id