BIOFLOW III Satellite-Italy Orsiro Stent System

Completed

• Conditions: Coronary Artery Diseases

• Registration Number: NCT02028728
• Lead Sponsor: Biotronik Italia S.p.A.

Brief 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).

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 Timeline

• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Study Start: 2014-03
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 609

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	12 months	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).

Secondary Outcome Measures

Name	Time	Method
TLF	6 and 18 months	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).
Stent Thrombosis	6, 12 and 18 months	Definite, Probable and Possible Stent Thrombosis
Clinical device success	Up to discharge	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.
Target Lesion Revascularization (TLR)	6, 12 and 18 months	Defined as any repeat revascularization of the target lesion
Clinical procedural success	up to seven days	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.
Target Vessel Revascularization (TVR)	6, 12 and 18 months	Any repeat revascularization of the target vessel.

Trial Locations

Locations (18)

Ospedale Sant'Anna; 🇮🇹 San Fermo della Battaglia, Como, 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

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