BIOFLOW III Satellite-Italy Orsiro Stent System

Coronary Artery Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028728
• Other study ID #: G1307
• Status: Completed
• Phase: N/A
• First received: December 19, 2013
• Last updated: September 28, 2017
• Start date: March 2014
• Est. completion date: July 2016

Study information

• Verified date: September 2017
• Source: Biotronik Italia S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 609
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Diseases
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Italy	Cardiologia Ospedaliera Policlinico Bari	Bari
Italy	Cardiologia Universitaria Policlinico Bari	Bari
Italy	Clinical Santa Maria	Bari
Italy	Ospedale Di Venere	Bari
Italy	Policlinico Conzorciale di Bari	Bari
Italy	P.O. Cardarelli	Campobasso
Italy	Azienda Ospedaliera Pugliese-Ciaccio	Catanzaro
Italy	Ospedale F. Veneziale	Isernia
Italy	A.O. Ospedale Civile Legnano	Legnano
Italy	AO Ospedale Civile Legnano, Fornaroli, Magenta	Magenta
Italy	Centro Cardiologico Monzino	Milano
Italy	Istituto Clinico Città Studi, Milano	Milano
Italy	Clinica Mediterranea	Napoli
Italy	Ospedale San Salvatore AORMN	Pesaro
Italy	European Hospital	Roma
Italy	Ospedale Sant'Anna	San Fermo della Battaglia	Como
Italy	Casa Sollievo della Sofferenza	San Giovanni Rotondo
Italy	Clinical Villa Verde	Taranto

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik Italia S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure (TLF)	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).	12 months
Secondary	TLF	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).	6 and 18 months
Secondary	Target Vessel Revascularization (TVR)	Any repeat revascularization of the target vessel.	6, 12 and 18 months
Secondary	Target Lesion Revascularization (TLR)	Defined as any repeat revascularization of the target lesion	6, 12 and 18 months
Secondary	Stent Thrombosis	Definite, Probable and Possible Stent Thrombosis	6, 12 and 18 months
Secondary	Clinical device success	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.	Up to discharge
Secondary	Clinical procedural success	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.	up to seven days