Clinical trial NCT02247492: BIOFLOW-III VIP Russia Registry 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 and Vulnerable Inflammation Parameter Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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 Russia
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 200
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). Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body inflammation status correlates with the clinical outcome.

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 neointimal 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. 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.

Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body inflammation status correlates with the clinical outcome.

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: Target Lesion Failure (TLF)
timeFrame: 6 and 36 months
measure: Target Vessel Revascularization (TVR)
timeFrame: 6 and 36 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 6 and 36 months
measure: Stent Thrombosis
timeFrame: 6, 12 and 36 months
measure: Clinical Device Success
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Clinical procedural success
timeFrame: up to seven days
measure: Vulnerable Inflammation Parameter (VIP)
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Ural Institute of Cardiology
city: Kemerovo
country: Russian Federation
facility: Research Institute for Complex Problems of Cardiovascular Diseases
city: Nizhniy Novgorod
country: Russian Federation
facility: Regional Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Scientific Research Institute of Circulation Pathology
city: Rostov-on-Don
country: Russian Federation
facility: City Emergency Clinical Hospital of Rostov-on-Don
city: Saint Petersburg
country: Russian Federation
facility: North-West Federal Medical Research Center named after V.A. Almazov
city: Tomsk
country: Russian Federation
facility: Institute of Cardiology, Tomsk Medical Research
Study officials:
affiliation: Novosibirsk Research Institute for Circulation
name: Evgeny Kretov, Dr.
role: PRINCIPAL_INVESTIGATOR
References: