Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent

Coronary Artery Disease Clinical Trial

— BIOFLOW-IV  

Official title:

BIOTRONIK-A Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects With up to Two de Novo Coronary Artery Lesions - IV

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01939249
• Other study ID #: C1204
• Status: Active, not recruiting
• Phase: N/A
• First received: September 6, 2013
• Last updated: June 23, 2017
• Start date: September 2013
• Est. completion date: January 2020

Study information

• Verified date: June 2017
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary lesions. The study is powered for non-inferiority with respect to Target Vessel Failure(TVF)at 12 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 585
• Est. completion date: January 2020
• Est. primary completion date: March 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Main Inclusion Criteria:

• Subject must provide written informed consent

• The target reference vessel diameter (RVD) is = 2.50 mm and = 3.75 mm assessed either visually or by online QCA.

• Target lesion length is = 26 mm (assessed either visual estimate or by online QCA) and can be covered by one study stent

• Single de novo lesion with = 50% and < 100% stenosis in up to 2 coronary arteries

Main Exclusion Criteria:

• Subject has evidence of myocardial infarction within 72 hours prior to the index procedure

• Planned intervention of non-target vessel(s) within 30 days after the index procedure

• Planned intervention of target vessel(s) after the index procedure

• Target lesion is located in the left main

• Target lesion is located in or supplied by an arterial or venous bypass graft

• Target lesion involves a side branch > 2.0 mm in diameter by visual estimate or by online QCA

• Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Abbott Laboratories Xience

• Biotronik Orsiro

Locations

Country	Name	City	State
Australia	Fiona Stanley Hospital	Murdoch
Australia	Prince of Wales Hospital Sydney	Sydney
Belgium	Gasthuisberg Leuven	Leuven,
Belgium	AZ Delta, H. Hart Roeselare	Roeselare
Denmark	Roskilde Sygehus Nord	Roskilde
Germany	Universitäts-Herzzentrum Freiburg Bad Krozingen	Bad Krozingen
Germany	Herz- und Diabeteszentrum NRW - Kardiologische Klinik	Bad Oeynhausen
Germany	Segeberger Kliniken GmbH	Bad Segeberg
Germany	Charite Campus Mitte - Med. klinik für Kardiologie	Berlin
Germany	Universitätsklinik Bonn	Bonn
Germany	Amper Kliniken AG	Dachau
Germany	Medizinische Hochschule Hannover (MHH), Klinik für Kardiologie und Angiologie	Hannover
Germany	Medizinische Klinik 8-Kardiologie -Klinikum Nürnberg Sued	Nürnberg
Israel	Rambam Health Corporation, Rambam Medical Center, Batgalim	Haifa
Israel	Hedasit Medical Research Services and Development Ltd. Hadassah Ein-Kerem Medical Center Kiryat Hadassah	Jerusalem,
Israel	Clalit Health Services, Rabin Medical Center, Cardiology	Petach Tikva
Japan	Tenjinkai Shinkoga Hospital	Fukuoka
Japan	Akanekai Tsuchiya General Hospital	Hiroshima
Japan	Hospital Hakodate	Hokkaido
Japan	Sakurakai Takahashi Hospital	Hyogo
Japan	Japan Organization of Occupational Health and Safety Kanto Rosai Hos-pital	Kanagawa
Japan	Okinawa Tokushukai Shonan Kamakura General Hospital	Kanagawa
Japan	Saiseikai Yokohamashi Tobu Hospital	Kanagawa
Japan	Japan Organization of Occupational Health and Safety Kansai Rosai Hospital	Kumamoto
Japan	Japan Organization of Occupational Health and Safety Kumamoto Rosai Hospital	Kumamoto
Japan	Toho University Ohashi Medical Center	Tokyo
Japan	Tokai University Hachioji Hospital	Tokyo
Netherlands	Onze Lieve Vrouwe Gasthuis (OLVG)	Amsterdam
Netherlands	Tergooi Blaricum	Blaricum
Netherlands	Amphia Hospital	Breda
Netherlands	Isala Klinieken	Zwolle
New Zealand	Cardiology Department, Christchurch Hospital	Christchurch
Poland	University Hospital Krakow	Krakow
Poland	Miedziowe Centrum Zdrowia SA	Lubin
Poland	Clinical Hospital Medical University Poznan	Poznan
Poland	General Cardiology & Haemodynamics Dept., Institute of Cardiology	Warsaw
Spain	Hospital Clínico y Provincial de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Virgen de la Macarena	Sevilla
Sweden	Universitetssjukhuset Örebro	Oerebrö
Sweden	Akademiska Sjukhuset	Uppsala
Switzerland	University Hospital Lausanne	Lausanne
Switzerland	CardioCentro Ticino	Lugano
Switzerland	University Hospital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Australia,  Belgium,  Denmark,  Germany,  Israel,  Japan,  Netherlands,  New Zealand,  Poland,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Vessel Failure		12 months post index procedure
Secondary	Rate of clinically-driven target lesion revascularization (TLR)		1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
Secondary	Rate of clinically-driven target vessel revascularization (TVR)		1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
Secondary	Rate of target lesion failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), emergent coronary artery bypass graft (CABG), any clinically-driven TLR		1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year