Deutsches Dual Therapy Stent Register

NCT02102997 | Terminated DMC

• 1 other identifier: DTS.DE Register V 1.2
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Procedural success

  Day of procedure

• MACE

  6 weeks and 12 months

• Stent induced serious adverse events (SAE)

  12 months

• Stent thrombosis

  12 months

• Thrombolysis in Myocardial Infarction (TIMI) bleeding

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OrbusNeich: lead

Study Sites (1)

Kardiologie Lukaskrankenhaus Neuss

Neuss, D-41464, Germany

Location

Related Publications (1)

• 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.

  PMID: 23523459 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 3, 2014
• Study Start: July 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 20, 2017

Record last verified: 2017-11

Locations

DE (1)