Clinical trial NCT02028728: BIOFLOW III Satellite-Italy Orsiro Stent System
Official title: Safety and Performance Registry for an All Comers Patient Population With the Limus Eluting Orsiro Stent Within Daily Clinical Practice III-Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Diseases
Keywords: International
Multicenter
Observational registry
Orsiro Drug Eluting Stent (DES)
Stenting
Treatment of coronary artery disease
Coronary revascularization
Percutaneous Coronary Intervention (PCI)
STEMI
NSTEMI
Ischemia
Angina
Acute Myocardial Infarction (AMI)
Small Vessels
Chronic Total Occlusion (CTO)
Lead sponsor: Biotronik Italia S.p.A.
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 609
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects requiring coronary revascularization with Drug Eluting Stents (DES)

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: TLF
timeFrame: 6 and 18 months
measure: Target Vessel Revascularization (TVR)
timeFrame: 6, 12 and 18 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 6, 12 and 18 months
measure: Stent Thrombosis
timeFrame: 6, 12 and 18 months
measure: Clinical device success
timeFrame: Up to discharge
measure: Clinical procedural success
timeFrame: up to seven days
Other outcomes:
Locations:
city: San Fermo della Battaglia
country: Italy
facility: Ospedale Sant'Anna
state: Como
city: Bari
country: Italy
facility: Cardiologia Ospedaliera Policlinico Bari
city: Bari
country: Italy
facility: Cardiologia Universitaria Policlinico Bari
city: Bari
country: Italy
facility: Clinical Santa Maria
city: Bari
country: Italy
facility: Ospedale Di Venere
city: Bari
country: Italy
facility: Policlinico Conzorciale di Bari
city: Campobasso
country: Italy
facility: P.O. Cardarelli
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Pugliese-Ciaccio
city: Isernia
country: Italy
facility: Ospedale F. Veneziale
city: Legnano
country: Italy
facility: A.O. Ospedale Civile Legnano
city: Magenta
country: Italy
facility: AO Ospedale Civile Legnano, Fornaroli, Magenta
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Milano
country: Italy
facility: Istituto Clinico Città Studi, Milano
city: Napoli
country: Italy
facility: Clinica Mediterranea
city: Pesaro
country: Italy
facility: Ospedale San Salvatore AORMN
city: Roma
country: Italy
facility: European Hospital
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza
city: Taranto
country: Italy
facility: Clinical Villa Verde
Study officials:
affiliation: BIOTRONIK ITALIA SPA
name: Martina Del Maestro
role: STUDY_DIRECTOR
References: