NCT02102997

Deutsches Dual Therapy Stent Register

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: OrbusNeich · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-08-01
• Completion: 2017-11-01
• First posted: 2014-04-03
• Last updated: 2017-11-20

Locations

1 site across 1 country: Germany