Clinical trial NCT01593059: BIOFLOW-III Romania Satellite Registry
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 Romania
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Myocardial Ischemia
Keywords: International
Multicenter
Observational registry
Orsiro Drug Eluting Stent (DES)
Stenting
Treatment of Coronary Artery Disease
Coronary revascularization
Percutaneous Coronary Intervention
STEMI
NSTEMI
Ischemia
Angina
Subgroups
Acute Myocardial Infarction
Diabetes
Small Vessels
Chronic Total Occlusion (CTO)
Lead sponsor: Biotronik Vertriebs-GmbH
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

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

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.

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
* Elective PCI with DES

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.

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Target Lesion Failure (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: At time of intervention
measure: Clinical Procedural Success
timeFrame: During the hospital stay to a maximum of the first seven days post index procedure
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Cardiovascular Diseases Institute CC Iliescu
city: Bucharest
country: Romania
facility: University Hospital Bucharest
city: Cluj Napoca
country: Romania
facility: County Emergency Hospital
city: Targu Mures
country: Romania
facility: Country Hospital
Study officials:
affiliation: University Hospital Bucharest
name: Dragos Vinereanu, Prof.
role: PRINCIPAL_INVESTIGATOR
References: