This trial is active, not recruiting.

Condition coronary artery disease
Treatments abbott laboratories xience, biotronik orsiro
Sponsor Biotronik AG
Start date September 2013
End date January 2016
Trial size 585 participants
Trial identifier NCT01939249, C1204


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Subjects assigned to Abbott Laboratories Xience can be treated with either the Xience Prime or Xience Xpedition drug eluting stent (DES).
abbott laboratories xience
Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro
biotronik orsiro

Primary Outcomes

Target Vessel Failure
time frame: 12 months post index procedure

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Principal investigator Shigeru Saito, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Biotronik AG.