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Study of the Orsiro Drug Eluting Stent System (BIOFLOW-II)

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)
Percutaneous Coronary Intervention (Orsiro DES)
Sponsored by
Biotronik AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  • Subject has provided a written informed consent
  • Single de novo lesion with ≥ 50% and <100% stenosis in up to 2 coronary arteries
  • The target lesion length is ≤ 26 mm
  • The target reference vessel diameter is ≥ 2.25 mm and ≤ 4.0 mm

Main Exclusion Criteria:

  • Evidence of myocardial infarction within 72 hours prior to index procedure
  • Unprotected left main coronary artery disease (stenosis >50%)
  • Three-vessel coronary artery disease at time of procedure Thrombus in target vessel
  • Target lesion involves a side branch > 2.0 mm in diameter
  • Heavily calcified lesion
  • Target lesion is located in or supplied by an arterial or venous bypass graft

Sites / Locations

  • Klinikum Wels-Grieskirchen
  • Hospital Prive Jacques Cartier Massy
  • CHU - Hospital Arnaud de Villeneuve
  • Polyclinique les Fleurs Ollioules
  • Heart Centre Bad Krozingen
  • Heart- and Diabetescentre NRW
  • Segeberger Kliniken GmbH
  • Charité Campus Mitte
  • Charité Campus Benjamin Franklin
  • Universityhospital Lübeck
  • Städtische Kliniken Neuss, Lukaskrankenhaus GmbH
  • Klinikum Nuernberg Sued
  • Universityhospital Rostock
  • Heart centre Semmelweis University
  • Pauls Stradins Clinical University Hospital
  • OLVG (Onze Lieve Vrouwe Gasthuis)
  • Hospital Clínico y Provincial de Barcelona
  • Hospital Universitario Puerta de Hierro de Majadahonda
  • Hospital Universitario Virgen de la Macarena
  • Cardiocentro Ticino
  • University Hospital of Bern (Inselspital)
  • University Hospital of Fribourg
  • University Hospital of Geneva
  • Cantone Hospital of Lucerne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Abbott Laboratories - Xience Prime DES

Biotronik - Orsiro DES

Arm Description

Outcomes

Primary Outcome Measures

Late Lumen Loss

Secondary Outcome Measures

Full Information

First Posted
May 18, 2011
Last Updated
May 30, 2018
Sponsor
Biotronik AG
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1. Study Identification

Unique Protocol Identification Number
NCT01356888
Brief Title
Study of the Orsiro Drug Eluting Stent System
Acronym
BIOFLOW-II
Official Title
BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With Single de Novo Coronary Artery Lesions - II
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abbott Laboratories - Xience Prime DES
Arm Type
Active Comparator
Arm Title
Biotronik - Orsiro DES
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)
Intervention Description
Stenting
Intervention Type
Device
Intervention Name(s)
Percutaneous Coronary Intervention (Orsiro DES)
Intervention Description
stenting
Primary Outcome Measure Information:
Title
Late Lumen Loss
Time Frame
9 months post index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Subject has provided a written informed consent Single de novo lesion with ≥ 50% and <100% stenosis in up to 2 coronary arteries The target lesion length is ≤ 26 mm The target reference vessel diameter is ≥ 2.25 mm and ≤ 4.0 mm Main Exclusion Criteria: Evidence of myocardial infarction within 72 hours prior to index procedure Unprotected left main coronary artery disease (stenosis >50%) Three-vessel coronary artery disease at time of procedure Thrombus in target vessel Target lesion involves a side branch > 2.0 mm in diameter Heavily calcified lesion Target lesion is located in or supplied by an arterial or venous bypass graft
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Windecker, MD
Organizational Affiliation
University Hospital (Inselspital) / Bern / Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thierry Lefèvre, MD
Organizational Affiliation
Institute Hospitalier Jaques Cartier / Massy / France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Wels-Grieskirchen
City
Wels
State/Province
Oberoesterreich
ZIP/Postal Code
4600
Country
Austria
Facility Name
Hospital Prive Jacques Cartier Massy
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
CHU - Hospital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Polyclinique les Fleurs Ollioules
City
Ollioules
ZIP/Postal Code
83192
Country
France
Facility Name
Heart Centre Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Heart- and Diabetescentre NRW
City
Bad Oeyenhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Segeberger Kliniken GmbH
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Charité Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universityhospital Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Städtische Kliniken Neuss, Lukaskrankenhaus GmbH
City
Neuss
ZIP/Postal Code
41464
Country
Germany
Facility Name
Klinikum Nuernberg Sued
City
Nuernberg
ZIP/Postal Code
90471
Country
Germany
Facility Name
Universityhospital Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Heart centre Semmelweis University
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
OLVG (Onze Lieve Vrouwe Gasthuis)
City
Amsterdam
ZIP/Postal Code
1091
Country
Netherlands
Facility Name
Hospital Clínico y Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro de Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41007
Country
Spain
Facility Name
Cardiocentro Ticino
City
Lugano
State/Province
Tessin
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
University Hospital of Bern (Inselspital)
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
University Hospital of Fribourg
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
University Hospital of Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Cantone Hospital of Lucerne
City
Lucerne
ZIP/Postal Code
6000
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29798778
Citation
Lefevre T, Haude M, Neumann FJ, Stangl K, Skurk C, Slagboom T, Sabate M, Goicolea J, Barragan P, Cook S, Macia JC, Windecker S. Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent: 5-Year Outcomes of the Randomized BIOFLOW-II Trial. JACC Cardiovasc Interv. 2018 May 28;11(10):995-1002. doi: 10.1016/j.jcin.2018.04.014.
Results Reference
result
PubMed Identifier
35212802
Citation
Hemetsberger R, Abdelghani M, Toelg R, Garcia-Garcia HM, Farhan S, Mankerious N, Elbasha K, Allali A, Windecker S, Lefevre T, Saito S, Kandzari D, Waksman R, Richardt G. Complex vs. non-complex percutaneous coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials. Clin Res Cardiol. 2022 Jul;111(7):795-805. doi: 10.1007/s00392-022-01994-4. Epub 2022 Feb 25.
Results Reference
derived
PubMed Identifier
34056911
Citation
Hemetsberger R, Abdelghani M, Toelg R, Mankerious N, Allali A, Garcia-Garcia HM, Windecker S, Lefevre T, Saito S, Slagboom T, Kandzari D, Koolen J, Waksman R, Richardt G. Impact of Coronary Calcification on Clinical Outcomes After Implantation of Newer-Generation Drug-Eluting Stents. J Am Heart Assoc. 2021 Jun 15;10(12):e019815. doi: 10.1161/JAHA.120.019815. Epub 2021 May 29.
Results Reference
derived
PubMed Identifier
32895004
Citation
Dan K, Garcia-Garcia HM, Kolm P, Windecker S, Saito S, Kandzari DE, Waksman R. Comparison of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents in Calcified or Small Vessel Lesions. Circ Cardiovasc Interv. 2020 Sep;13(9):e009189. doi: 10.1161/CIRCINTERVENTIONS.120.009189. Epub 2020 Sep 8.
Results Reference
derived
PubMed Identifier
32890442
Citation
Toelg R, Slagboom T, Waltenberger J, Lefevre T, Saito S, Kandzari DE, Koolen J, Richardt G. Individual patient data analysis of the BIOFLOW study program comparing safety and efficacy of a bioresorbable polymer sirolimus eluting stent to a durable polymer everolimus eluting stent. Catheter Cardiovasc Interv. 2021 Nov 1;98(5):848-856. doi: 10.1002/ccd.29254. Epub 2020 Sep 5.
Results Reference
derived
PubMed Identifier
25634905
Citation
Windecker S, Haude M, Neumann FJ, Stangl K, Witzenbichler B, Slagboom T, Sabate M, Goicolea J, Barragan P, Cook S, Piot C, Richardt G, Merkely B, Schneider H, Bilger J, Erne P, Waksman R, Zaugg S, Juni P, Lefevre T. Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial. Circ Cardiovasc Interv. 2015 Feb;8(2):e001441. doi: 10.1161/CIRCINTERVENTIONS.114.001441.
Results Reference
derived

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Study of the Orsiro Drug Eluting Stent System

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