Deutsches Dual Therapy Stent Register

Coronary Artery Disease Clinical Trial

— DTS Register  

Official title:

Deutsches Dual Therapy Stent Register

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02102997
• Other study ID #: DTS.DE Register V 1.2
• Status: Terminated
• Phase: N/A
• First received: March 24, 2014
• Last updated: November 16, 2017
• Start date: July 2013
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: OrbusNeich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: November 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Germany	Kardiologie Lukaskrankenhaus Neuss	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
OrbusNeich

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedural success	Successful implantation of the stent and a residual stenosis of less than 20%	Day of procedure
Secondary	MACE	MACE is defined as the composite of of death, myocardial infarction and target lesion revascularization	6 weeks and 12 months
Secondary	Stent induced serious adverse events (SAE)		12 months
Secondary	Stent thrombosis	Classified per ARC definitions as definite, probable or possible stent thrombosis	12 months
Secondary	Thrombolysis in Myocardial Infarction (TIMI) bleeding	Bleeding as defined by the TIMI criteria: major, minor or minimal	12 months