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
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Device: Abbott Laboratories Xience
Device: Biotronik Orsiro

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • Target Vessel Failure [ Time Frame: 12 months post index procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 585
Study Start Date: September 2013
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Device: Abbott Laboratories Xience
Experimental: Biotronik Orsiro
Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro
Device: Biotronik Orsiro

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01939249

Contacts
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

Locations
Germany
Segeberger Kliniken GmbH Recruiting
Bad Segeberg, Germany, 23795
Contact: Ralph Tölg, MD       ralph.toelg@segebergerkliniken.de   
Principal Investigator: Ralph Tölg, MD         
Sponsors and Collaborators
Biotronik AG
Investigators
Principal Investigator: Shigeru Saito, MD Okinawa Tokushukai Shonan Kamakura General Hospital
Principal Investigator: Ton Slagboom, MD Onze Lieve Vrouwe Gasthuis
  More Information

No publications provided

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01939249     History of Changes
Other Study ID Numbers: C1204
Study First Received: September 6, 2013
Last Updated: March 27, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014