BIOFLOW-III All-comers Orsiro Safety and Performance Registry

Coronary Artery Disease Clinical Trial

— BIOFLOW-III  

Official title:

BIOTRONIK - Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01553526
• Other study ID #: C1101
• Status: Active, not recruiting
• Phase: N/A
• First received: March 8, 2012
• Last updated: August 29, 2016
• Start date: August 2011
• Est. completion date: June 2017

Study information

• Verified date: August 2016
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionChile: Institutional Review BoardDenmark: National Board of HealthFrance: Conseil National de l'Ordre des MédecinsGermany: Ethics CommissionIreland: Medical Ethics Research CommitteeItaly: Ethics CommitteeLatvia: Institutional Review BoardNetherlands: Medical Ethics Review Committee (METC)Portugal: Ethics Committee for Clinical ResearchSpain: Comité Ético de Investigación ClínicaSweden: Regional Ethical Review BoardSwitzerland: EthikkommissionUnited Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

Description:

For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30%-50%. Such rates of recurrence have serious economic consequences.

Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures.

The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilised on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration.

These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease. This observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1356
• Est. completion date: June 2017
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic coronary artery disease

• Subject has signed informed consent for data release

• Subject is geographically stable and willing to participate at all follow-up assessments

• Subject is = 18 years

Exclusion Criteria:

• Subject did not sign informed consent for data release

• Pregnancy

• Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media

• Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained

• Currently participating in another study and primary endpoint is not reached yet.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia

Locations

Country	Name	City	State
Austria	University Hospital Innsbruck	Innsbruck
Chile	Clinica Tabancura	Santiago
Denmark	Gentofte Universitets Hospital	Hellerup
France	Clinique Rhone Durance	Avignon
France	CHU Bocage Dijon	Dijon
France	CCML Le Plessis Robinson	Le Plessis Robinson
France	CHRU Brabois Nancy	Nancy
France	CH Niort	Niort
France	Clinique Saint Hilaire Rouen	Rouen
France	CHRU Rangueil Toulouse	Toulouse
France	CHG Troyes	Troyes
France	CH Valence	Valence
Germany	Segeberger Kliniken	Bad Segeberg
Germany	Klinikum im Friedrichshain	Berlin
Germany	Kardiologisch-Angiologische Praxis Hegeler	Bremen
Germany	Klinikum Coburg	Coburg
Germany	Krankenhaus Martha Maria gGmbH, Klinik fuer Innere Medizin I	Halle
Germany	Asklepiosklinik St. Georg	Hamburg
Germany	Uniklinik Heidelberg, Medizinische Uniklinik	Heidelberg
Germany	Klinikum Landshut-Achdorf Medizinische Klinik I	Landshut
Germany	University of Leipzig	Leipzig
Germany	Universitaetsklinikum Muenster	Muenster
Germany	HZ Muenchen-Bogenhausen, Klinik fuer Kardiologie und Internistische Intensivmedizin	Munich
Germany	LMU-Großhadern	Munich
Germany	Uniklink Regensburg	Regensburg
Germany	Kliniken Villingen - Kardiologie	Villingen-Schwenningen
Italy	Centro cardiologico Monzino	Milano
Italy	Cattedra Universitaria, Divisione Cardiologia, Policlinico Tor Vergata	Rome
Latvia	Pauls Stradins Clinical University Hospital	Riga
Latvia	Riga Eastern Clinical University Hospital	Riga
Netherlands	VU Medical Center HV Amsterdam	Amsterdam
Netherlands	Alysis Hospital	Arnhem
Netherlands	Amphia Ziekenhuis Breda	Breda
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	ZorgSaam Terneuzen	Terneuzen
Netherlands	Twee Steden Hospital Tilburg	Tilburg
Portugal	Centro Hospitalar de Coimbra	Sao Martinho do Bispo
Spain	Hospital de Navarra	Pamplona
Sweden	Universitetssjukhuset Oerebro, Kardiologiska Kliniken	Oerebro
Switzerland	Clinique Cecil	Lausanne
Switzerland	Kantonsspital Liestal	Liestal
United Kingdom	Craigavon Area Hospital Lurgan Road Co. Armagh, Northern Ireland	Belfast
United Kingdom	The Heart Hospital, UCLH	London

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Austria,  Chile,  Denmark,  France,  Germany,  Italy,  Latvia,  Netherlands,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure (TLF)	Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)	12 months	Yes
Secondary	Target Lesion Failure (TLF)		6, 36 and 60 months	Yes
Secondary	Target Vessel Revascularization (TVR)	Any repeat revascularization of the target vessel.	6, 12, 36 and 60 months	Yes
Secondary	Target Lesion Revascularization (TLR)	Any repeat revascularization of the target lesion.	6, 12, 36 and 60 months	Yes
Secondary	Stent Thrombosis		6, 12, 36 and 60 months	Yes
Secondary	Clinical Device Success		At time of intervention	No
Secondary	Clinical Procedural Success		During the hospital stay to a maximum of the first seven days post index procedure	Yes