Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Biotronik AG
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01939249
First received: September 6, 2013
Last updated: March 27, 2014
Last verified: March 2014

September 6, 2013
March 27, 2014
September 2013
October 2015   (final data collection date for primary outcome measure)
Target Vessel Failure [ Time Frame: 12 months post index procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01939249 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Abbott Laboratories Xience
  • Device: Biotronik Orsiro
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
585
October 2019
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Lennart Ivarsson, PhD +41 44 864 ext 5518 lennart.ivarsson@biotronik.com
Contact: Yuki Mizukami +81 3 3473 ext 7483 yuki.mizukami@biotronik.co.jp
Germany
 
NCT01939249
C1204
No
Biotronik AG
Biotronik AG
Not Provided
Principal Investigator: Shigeru Saito, MD Okinawa Tokushukai Shonan Kamakura General Hospital
Principal Investigator: Ton Slagboom, MD Onze Lieve Vrouwe Gasthuis
Biotronik AG
March 2014

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