Study of the Orsiro Drug Eluting Stent System

Coronary Artery Disease Clinical Trial

— BIOFLOW-II  

Official title:

BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With Single de Novo Coronary Artery Lesions - II

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01356888
• Other study ID #: C1004
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2011
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 452
• Est. completion date: December 2018
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Main 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)
Stenting
• Percutaneous Coronary Intervention (Orsiro DES)
stenting

Locations

Country	Name	City	State
Austria	Klinikum Wels-Grieskirchen	Wels	Oberoesterreich
France	Hospital Prive Jacques Cartier Massy	Massy
France	CHU - Hospital Arnaud de Villeneuve	Montpellier
France	Polyclinique les Fleurs Ollioules	Ollioules
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	Charité Campus Mitte	Berlin
Germany	Universityhospital Lübeck	Lübeck
Germany	Städtische Kliniken Neuss, Lukaskrankenhaus GmbH	Neuss
Germany	Klinikum Nuernberg Sued	Nuernberg
Germany	Universityhospital Rostock	Rostock
Hungary	Heart centre Semmelweis University	Budapest
Latvia	Pauls Stradins Clinical University Hospital	Riga
Netherlands	OLVG (Onze Lieve Vrouwe Gasthuis)	Amsterdam
Spain	Hospital Clínico y Provincial de Barcelona	Barcelona
Spain	Hospital Universitario Puerta de Hierro de Majadahonda	Madrid
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Switzerland	University Hospital of Bern (Inselspital)	Bern
Switzerland	University Hospital of Fribourg	Fribourg
Switzerland	University Hospital of Geneva	Geneva
Switzerland	Cantone Hospital of Lucerne	Lucerne
Switzerland	Cardiocentro Ticino	Lugano	Tessin

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Austria,  France,  Germany,  Hungary,  Latvia,  Netherlands,  Spain,  Switzerland, 

References & Publications (1)

Lefèvre T, Haude M, Neumann FJ, Stangl K, Skurk C, Slagboom T, Sabaté M, Goicolea J, Barragan P, Cook S, Macia JC, Windecker S. Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent: 5-Year Out — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late Lumen Loss		9 months post index procedure