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

Not Applicable

• Conditions: Coronary Artery Disease

• Registration Number: NCT01939249
• Lead Sponsor: Biotronik AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-11
• Primary Completion: 2016-03-23
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-26
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 585

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Target Vessel Failure	12 months post index procedure

Secondary Outcome Measures

Name	Time	Method
Rate of clinically-driven target lesion revascularization (TLR)	1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
Rate of clinically-driven target vessel revascularization (TVR)	1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
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

Trial Locations

Locations (45)

Fiona Stanley Hospital; 🇦🇺 Murdoch, Australia

Prince of Wales Hospital Sydney; 🇦🇺 Sydney, Australia

Gasthuisberg Leuven; 🇧🇪 Leuven,, Belgium

AZ Delta, H. Hart Roeselare; 🇧🇪 Roeselare, Belgium

Roskilde Sygehus Nord; 🇩🇰 Roskilde, Denmark

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

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