Clinical trial NCT02029092: BIOFLOW III Satellite-ELADIS Orsiro Stent System
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- ELADIS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
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
Chronical Total Occlusion (CTO)
Lead sponsor: C.E.M. Biotronik, S.A.
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 404
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: This registry is a clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). It 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.

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 and safety of ORSIRO drug eluting stent system in daily clinical practice.

Eligibility criteria: 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 of age.

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 after PCI unless dual antiplatelet therapy will be maintained
* Currently participating in another study and primary endpoint is not yet reached.

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: TLF
timeFrame: 6 months
measure: Target Vessel Revascularization (TVR)
timeFrame: 6 and 12 months
measure: Target lesion revascularization (TLR)
timeFrame: 6 and 12 months
measure: Stent Thrombosis rate
timeFrame: 6 and 12 months
measure: Device success
timeFrame: up to discharge
measure: Procedure success
timeFrame: up to 7 days after procedure
Other outcomes:
Locations:
city: León
country: Spain
facility: Hospital Universitario León
state: A/Altos de Nava s/n
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Barcelona
country: Spain
facility: Hospital Vall D' Hebron
city: Cadiz
country: Spain
facility: Hospital G.de Jerez de la Frontera
city: Gasteiz / Vitoria
country: Spain
facility: Hospital de Txagorritxu
city: Murcia
country: Spain
facility: Hospital Univ. Virgen de la Arrixaca
city: Mérida
country: Spain
facility: Hospital de Mérida
city: Sabadell
country: Spain
facility: Hospital Parc Tauli
city: Santiago de Compostela
country: Spain
facility: Complejo de Hospitalario de Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
city: Valencia
country: Spain
facility: Hospital Doctor Peset
city: Vizcaya
country: Spain
facility: Hospital de Cruces
Study officials:
affiliation: CEM BIOTRONIK SA
name: Sonia Martin
role: STUDY_DIRECTOR
References: