BIOFLOW-III All-comers Orsiro Safety and Performance Registry

Sponsor

Biotronik AG (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01553526

Collaborator

(none)

1,356

Enrollment

Locations

Duration (Months)

31.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Myocardial Ischemia

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

1356 participants

Time Perspective:

Prospective

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Mar 1, 2013

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Orsiro DES

Outcome Measures

Primary Outcome Measures

Target Lesion Failure (TLF) [12 months]
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)

Secondary Outcome Measures

Target Lesion Failure (TLF) [6, 36 and 60 months]
Target Vessel Revascularization (TVR) [6, 12, 36 and 60 months]
Any repeat revascularization of the target vessel.
Target Lesion Revascularization (TLR) [6, 12, 36 and 60 months]
Any repeat revascularization of the target lesion.
Stent Thrombosis [6, 12, 36 and 60 months]
Clinical Device Success [At time of intervention]
Clinical Procedural Success [During the hospital stay to a maximum of the first seven days post index procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University Hospital Innsbruck	Innsbruck	Austria	6020
2	Clinica Tabancura	Santiago	Chile	Vitacura
3	Gentofte Universitets Hospital	Hellerup	Denmark	2900
4	Clinique Rhone Durance	Avignon	France	84082
5	CHU Bocage Dijon	Dijon	France	21034
6	CCML Le Plessis Robinson	Le Plessis Robinson	France	92350
7	CHRU Brabois Nancy	Nancy	France	54500
8	CH Niort	Niort	France	79000
9	Clinique Saint Hilaire Rouen	Rouen	France	76000
10	CHRU Rangueil Toulouse	Toulouse	France	31403
11	CHG Troyes	Troyes	France	10003
12	CH Valence	Valence	France	26953
13	Segeberger Kliniken	Bad Segeberg	Germany	23795
14	Klinikum im Friedrichshain	Berlin	Germany	10249
15	Kardiologisch-Angiologische Praxis Hegeler	Bremen	Germany	28277
16	Klinikum Coburg	Coburg	Germany	96450
17	Krankenhaus Martha Maria gGmbH, Klinik fuer Innere Medizin I	Halle	Germany	06120
18	Asklepiosklinik St. Georg	Hamburg	Germany	20099
19	Uniklinik Heidelberg, Medizinische Uniklinik	Heidelberg	Germany	69120
20	Klinikum Landshut-Achdorf Medizinische Klinik I	Landshut	Germany	84036
21	University of Leipzig	Leipzig	Germany	04103
22	Universitaetsklinikum Muenster	Muenster	Germany	48149
23	LMU-Großhadern	Munich	Germany	81377
24	HZ Muenchen-Bogenhausen, Klinik fuer Kardiologie und Internistische Intensivmedizin	Munich	Germany	81925
25	Uniklink Regensburg	Regensburg	Germany	93053
26	Kliniken Villingen - Kardiologie	Villingen-Schwenningen	Germany	78050
27	Centro cardiologico Monzino	Milano	Italy
28	Cattedra Universitaria, Divisione Cardiologia, Policlinico Tor Vergata	Rome	Italy	00133
29	Pauls Stradins Clinical University Hospital	Riga	Latvia	1002
30	Riga Eastern Clinical University Hospital	Riga	Latvia	1038
31	VU Medical Center HV Amsterdam	Amsterdam	Netherlands	1081 HV
32	Alysis Hospital	Arnhem	Netherlands	6815 AD
33	Amphia Ziekenhuis Breda	Breda	Netherlands	4818 CK
34	St. Antonius Ziekenhuis	Nieuwegein	Netherlands	3435 CM
35	ZorgSaam Terneuzen	Terneuzen	Netherlands	4535 PA
36	Twee Steden Hospital Tilburg	Tilburg	Netherlands	5042 AD
37	Centro Hospitalar de Coimbra	Sao Martinho do Bispo	Portugal	3041-801
38	Hospital de Navarra	Pamplona	Spain	31008
39	Universitetssjukhuset Oerebro, Kardiologiska Kliniken	Oerebro	Sweden	701 85
40	Clinique Cecil	Lausanne	Switzerland	1003
41	Kantonsspital Liestal	Liestal	Switzerland	4410
42	Craigavon Area Hospital Lurgan Road Co. Armagh, Northern Ireland	Belfast	United Kingdom	BT63 5QQ
43	The Heart Hospital, UCLH	London	United Kingdom	W1G 8PH