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

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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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Abbott Laboratories Xience Device: Biotronik Orsiro Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2013
Actual Primary Completion Date : March 23, 2016
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Target Vessel Failure [ Time Frame: 12 months post index procedure ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939249


  Show 45 Study Locations
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

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01939249     History of Changes
Other Study ID Numbers: C1204
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs