BIOFLOW III Satellite-Italy Orsiro Stent System

Sponsor

Biotronik Italia S.p.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT02028728

Collaborator

(none)

609

Enrollment

Locations

Actual Duration (Months)

33.8

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry. The sample size maybe increased in order to reach the subgroup sizes (Diabetes, small vessel, AMI and CTO).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Diseases

Detailed Description

For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil 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 to 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 to 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 immobilized on the stent surface or released from a polymer matrix), which inhibits neontimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in 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.

Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the collection of clinical evidence for the clinical Performance.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

609 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Orsiro

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), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR).

Secondary Outcome Measures

TLF [6 and 18 months]
Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR).
Target Vessel Revascularization (TVR) [6, 12 and 18 months]
Any repeat revascularization of the target vessel.
Target Lesion Revascularization (TLR) [6, 12 and 18 months]
Defined as any repeat revascularization of the target lesion
Stent Thrombosis [6, 12 and 18 months]
Definite, Probable and Possible Stent Thrombosis
Clinical device success [Up to discharge]
Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without use of a device outside the assigned treatment strategy.
Clinical procedural success [up to seven days]
Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event 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 signed informed consent for data release
Subject is geographically stable and willing to participate at all follow up assessments
Subject is ≥ 18 years of age

Exclusion Criteria:

Subject did not sign informed consent
Pregnancy
Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
Currently participating in another study and primary endpoint not reached yet

Contacts and Locations

Locations

	Site	City	State	Country
1	Ospedale Sant'Anna	San Fermo della Battaglia	Como	Italy
2	Cardiologia Ospedaliera Policlinico Bari	Bari		Italy
3	Cardiologia Universitaria Policlinico Bari	Bari		Italy
4	Clinical Santa Maria	Bari		Italy
5	Ospedale Di Venere	Bari		Italy
6	Policlinico Conzorciale di Bari	Bari		Italy
7	P.O. Cardarelli	Campobasso		Italy
8	Azienda Ospedaliera Pugliese-Ciaccio	Catanzaro		Italy
9	Ospedale F. Veneziale	Isernia		Italy
10	A.O. Ospedale Civile Legnano	Legnano		Italy
11	AO Ospedale Civile Legnano, Fornaroli, Magenta	Magenta		Italy
12	Centro Cardiologico Monzino	Milano		Italy
13	Istituto Clinico Città Studi, Milano	Milano		Italy
14	Clinica Mediterranea	Napoli		Italy
15	Ospedale San Salvatore AORMN	Pesaro		Italy
16	European Hospital	Roma		Italy
17	Casa Sollievo della Sofferenza	San Giovanni Rotondo		Italy
18	Clinical Villa Verde	Taranto		Italy