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Deutsches Dual Therapy Stent Register

NCT02102997 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2017-11-20

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • OrbusNeich

    lead INDUSTRY

Principal Investigators

  • Jochen Wöhrle, MD, PhD · Universitätsklinikum Ulm, Klinik für Innere Medizin II Albert-Einstein-Allee 23, 89081 Ulm, Germany

  • Michael Haude, MD, PhD · Kardiologie Lukaskrankenhaus Neuss Preußenstraße 84 D-41464 Neuss, Germany

  • Bernward Lauer, MD, PhD · Klinik für Kardiologie, Zentralklinik Bad Berka GmbH, Robert-Koch-Allee 9 99437 Bad Berka, Germany

  • Volker Schächinger, MD, PhD · Kardiologie, Angiologie, Pneumologie, Intensivmedizin Klinikum Fulda gAG Pacelliallee 4 - 36043 Fulda, Germany

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-08-01
Completion
2017-11-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02102997 on ClinicalTrials.gov