Clinical trial NCT01356888: Study of the Orsiro Drug Eluting Stent System
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
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2011-05-20
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Late Lumen Loss
timeFrame: 9 months post index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
state: Oberoesterreich
city: Massy
country: France
facility: Hospital Prive Jacques Cartier Massy
city: Montpellier
country: France
facility: CHU - Hospital Arnaud de Villeneuve
city: Ollioules
country: France
facility: Polyclinique les Fleurs Ollioules
city: Bad Krozingen
country: Germany
facility: Heart Centre Bad Krozingen
city: Bad Oeyenhausen
country: Germany
facility: Heart- and Diabetescentre NRW
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Berlin
country: Germany
facility: Charité Campus Mitte
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin
city: Lübeck
country: Germany
facility: Universityhospital Lübeck
city: Neuss
country: Germany
facility: Städtische Kliniken Neuss, Lukaskrankenhaus GmbH
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg Sued
city: Rostock
country: Germany
facility: Universityhospital Rostock
city: Budapest
country: Hungary
facility: Heart centre Semmelweis University
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Amsterdam
country: Netherlands
facility: OLVG (Onze Lieve Vrouwe Gasthuis)
city: Barcelona
country: Spain
facility: Hospital Clínico y Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro de Majadahonda
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
state: Tessin
city: Bern
country: Switzerland
facility: University Hospital of Bern (Inselspital)
city: Fribourg
country: Switzerland
facility: University Hospital of Fribourg
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
city: Lucerne
country: Switzerland
facility: Cantone Hospital of Lucerne
Study officials:
affiliation: University Hospital (Inselspital) / Bern / Switzerland
name: Stephan Windecker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute Hospitalier Jaques Cartier / Massy / France
name: Thierry Lefèvre, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.