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Coronary Artery DiseaseDTS RegisterNCT02102997

Deutsches Dual Therapy Stent Register

An observational study of Coronary Artery Disease, run by OrbusNeich at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronary Artery Disease
How many people
130 participants
Where
1 siteGermany
Study dates
Jul 2013to Nov 2017
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Kardiologie Lukaskrankenhaus Neuss

    Neuss, D-41464

Other trials in Germany

About this study

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.

Read the 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.

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
Medical subject headings
Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 months

Secondary outcomes (5)

  1. Procedural success

    Successful implantation of the stent and a residual stenosis of less than 20%

    Measured: Day of procedure

  2. MACE

    MACE is defined as the composite of of death, myocardial infarction and target lesion revascularization

    Measured: 6 weeks and 12 months

  3. Stent induced serious adverse events (SAE)

    Measured: 12 months

  4. Stent thrombosis

    Classified per ARC definitions as definite, probable or possible stent thrombosis

    Measured: 12 months

  5. Thrombolysis in Myocardial Infarction (TIMI) bleeding

    Bleeding as defined by the TIMI criteria: major, minor or minimal

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2014 (estimated)
  2. Study startJul 2013
  3. Primary completion1 Aug 2017
  4. Study completionNov 2017

Why it stopped: Low enrolment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
130 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02102997
Sponsor's protocol ID
DTS.DE Register V 1.2
Acronym
DTS Register
Status last verified
Nov 2017
First submitted
24 Mar 2014
Last updated
20 Nov 2017
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 23523459

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by OrbusNeich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Low enrolment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Vessel Failure (TVF) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02102997, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.

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Deutsches Dual Therapy Stent Register (NCT02102997) | AzTrials