BIOFLOW III Satellite-ELADIS Orsiro Stent System

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT02029092
• Lead Sponsor: C.E.M. Biotronik, S.A.

Brief Summary

This registry is a clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (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.

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 and safety of ORSIRO drug eluting stent system in daily clinical practice.

Study Timeline

• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Study Start: 2014-02
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-26
• Last Update Posted: 2017-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

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 of age.

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 after PCI unless dual antiplatelet therapy will be maintained
• Currently participating in another study and primary endpoint is not yet reached.

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 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).
Target Vessel Revascularization (TVR)	6 and 12 months	Target Vessel Revascularization (TVR)
Target lesion revascularization (TLR)	6 and 12 months	Target lesion revascularization (TLR)
Stent Thrombosis rate	6 and 12 months	Stent Thrombosis rate
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, without using any adjunctive device outside the assigned treatment strategy
Procedure success	up to 7 days after procedure	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, without using any adjunctive device and without the occurrence of ischemia-driven major cardiac event during the hospital stay to a maximum of the first seven days post index procedure.

Trial Locations

Locations (14)

Hospital Virgen del Rocio; 🇪🇸 Sevilla, Spain

Hospital Univ. Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital de Mérida; 🇪🇸 Mérida, Spain

Hospital de Txagorritxu; 🇪🇸 Gasteiz / Vitoria, Spain

Hospital Clinico de Valencia; 🇪🇸 Valencia, Spain

Hospital Doctor Peset; 🇪🇸 Valencia, Spain

Hospital Parc Tauli; 🇪🇸 Sabadell, Spain

Hospital Mutua de Terrassa; 🇪🇸 Terrassa, Spain

Hospital Vall D' Hebron; 🇪🇸 Barcelona, Spain

Hospital de Cruces; 🇪🇸 Vizcaya, Spain

Hospital Infanta Cristina; 🇪🇸 Badajoz, Spain

Hospital G.de Jerez de la Frontera; 🇪🇸 Cadiz, Spain

Hospital Universitario León; 🇪🇸 León, A/Altos de Nava s/n, Spain

Complejo de Hospitalario de Santiago; 🇪🇸 Santiago de Compostela, Spain