Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01939249
Recruitment Status : Active, not recruiting
First Posted : September 11, 2013
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Biotronik AG

Tracking Information
First Submitted Date  ICMJE September 6, 2013
First Posted Date  ICMJE September 11, 2013
Last Update Posted Date June 26, 2017
Study Start Date  ICMJE September 2013
Actual Primary Completion Date March 23, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2013)
Target Vessel Failure [ Time Frame: 12 months post index procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01939249 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Device: Abbott Laboratories Xience
  • Device: Biotronik Orsiro
Study Arms  ICMJE
  • Active Comparator: Abbott Laboratories Xience
    Subjects assigned to Abbott Laboratories Xience can be treated with either the Xience Prime or Xience Xpedition drug eluting stent (DES).
    Intervention: Device: Abbott Laboratories Xience
  • Experimental: Biotronik Orsiro
    Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro
    Intervention: Device: Biotronik Orsiro
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2013)
585
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Actual Primary Completion Date March 23, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Denmark,   Germany,   Israel,   Japan,   Netherlands,   New Zealand,   Poland,   Spain,   Sweden,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01939249
Other Study ID Numbers  ICMJE C1204
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biotronik AG
Study Sponsor  ICMJE Biotronik AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shigeru Saito, MD Okinawa Tokushukai Shonan Kamakura General Hospital
Principal Investigator: Ton Slagboom, MD Onze Lieve Vrouwe Gasthuis
PRS Account Biotronik AG
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP