BIOFLOW III Satellite-Italy Orsiro Stent System

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

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Diseases

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.

• Study Type: Observational
• Enrollment (Actual): 609

Contacts and Locations

Study Locations

• Italy
  • Bari, 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
  • Campobasso, Italy
    • P.O. Cardarelli
  • Catanzaro, Italy
    • Azienda Ospedaliera Pugliese-Ciaccio
  • Isernia, Italy
    • Ospedale F. Veneziale
  • Legnano, Italy
    • A.O. Ospedale Civile Legnano
  • Magenta, Italy
    • AO Ospedale Civile Legnano, Fornaroli, Magenta
  • Milano, Italy
    • Centro Cardiologico Monzino
  • Milano, Italy
    • Istituto Clinico Città Studi, Milano
  • Napoli, Italy
    • Clinica Mediterranea
  • Pesaro, Italy
    • Ospedale San Salvatore AORMN
  • Roma, Italy
    • European Hospital
  • San Giovanni Rotondo, Italy
    • Casa Sollievo Della Sofferenza
  • Taranto, Italy
    • Clinical Villa Verde
  • Como
    • San Fermo della Battaglia, Como, Italy
      • Ospedale Sant'Anna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All subjects requiring coronary revascularization with Drug Eluting Stents (DES)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Orsiro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Vessel Revascularization (TVR)	Any repeat revascularization of the target vessel.	6, 12 and 18 months
Stent Thrombosis	Definite, Probable and Possible Stent Thrombosis	6, 12 and 18 months
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
Target Lesion Revascularization (TLR)	Defined as any repeat revascularization of the target lesion	6, 12 and 18 months
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
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

Collaborators and Investigators

• Sponsor: Biotronik Italia S.p.A.
• Investigators: Study Director: Martina Del Maestro, BIOTRONIK ITALIA SPA

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 7, 2014

Study Record Updates

• Last Update Posted (Actual): October 2, 2017
• Last Update Submitted That Met QC Criteria: September 28, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: STEMI; Angina; Ischemia; International; NSTEMI; Multicenter; Percutaneous Coronary Intervention (PCI); Observational registry; Orsiro Drug Eluting Stent (DES); Stenting; Coronary revascularization; Small Vessels; Chronic Total Occlusion (CTO); Treatment of coronary artery disease; Acute Myocardial Infarction (AMI)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: G1307