Study of the Orsiro Drug Eluting Stent System

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Device: Percutaneous Coronary Intervention (Orsiro DES); Device: Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)

• Registration Number: NCT01356888
• Lead Sponsor: Biotronik AG

Brief Summary

The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-18
• Study First Submitted QC: 2011-05-19
• Study First Posted: 2011-05-20
• Primary Completion: 2013-07
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-05-31
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 452

Inclusion Criteria

• Subject has provided a written informed consent
• Single de novo lesion with ≥ 50% and <100% stenosis in up to 2 coronary arteries
• The target lesion length is ≤ 26 mm
• The target reference vessel diameter is ≥ 2.25 mm and ≤ 4.0 mm

Main

Exclusion Criteria

• Evidence of myocardial infarction within 72 hours prior to index procedure
• Unprotected left main coronary artery disease (stenosis >50%)
• Three-vessel coronary artery disease at time of procedure Thrombus in target vessel
• Target lesion involves a side branch > 2.0 mm in diameter
• Heavily calcified lesion
• Target lesion is located in or supplied by an arterial or venous bypass graft

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biotronik - Orsiro DES	Percutaneous Coronary Intervention (Orsiro DES)	-
Abbott Laboratories - Xience Prime DES	Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)	-

Primary Outcome Measures

Name	Time	Method
Late Lumen Loss	9 months post index procedure

Trial Locations

Locations (24)

Pauls Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

Polyclinique les Fleurs Ollioules; 🇫🇷 Ollioules, France

Klinikum Wels-Grieskirchen; 🇦🇹 Wels, Oberoesterreich, Austria

Hospital Prive Jacques Cartier Massy; 🇫🇷 Massy, France

University Hospital of Fribourg; 🇨🇭 Fribourg, Switzerland

Cantone Hospital of Lucerne; 🇨🇭 Lucerne, Switzerland

CHU - Hospital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

Hospital Clínico y Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Charité Campus Mitte; 🇩🇪 Berlin, Germany

University Hospital of Geneva; 🇨🇭 Geneva, Switzerland

Städtische Kliniken Neuss, Lukaskrankenhaus GmbH; 🇩🇪 Neuss, Germany

Heart Centre Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Heart- and Diabetescentre NRW; 🇩🇪 Bad Oeyenhausen, Germany

Segeberger Kliniken GmbH; 🇩🇪 Bad Segeberg, Germany

Charité Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Universityhospital Lübeck; 🇩🇪 Lübeck, Germany

Heart centre Semmelweis University; 🇭🇺 Budapest, Hungary

Klinikum Nuernberg Sued; 🇩🇪 Nuernberg, Germany

Hospital Universitario Virgen de la Macarena; 🇪🇸 Sevilla, Spain

Universityhospital Rostock; 🇩🇪 Rostock, Germany

OLVG (Onze Lieve Vrouwe Gasthuis); 🇳🇱 Amsterdam, Netherlands

Cardiocentro Ticino; 🇨🇭 Lugano, Tessin, Switzerland

Hospital Universitario Puerta de Hierro de Majadahonda; 🇪🇸 Madrid, Spain

University Hospital of Bern (Inselspital); 🇨🇭 Bern, Switzerland