BIOFLOW III Satellite-ELADIS Orsiro Stent System

Coronary Artery Disease Clinical Trial

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- ELADIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029092
• Other study ID #: G1302
• Status: Completed
• Phase: N/A
• First received: December 19, 2013
• Last updated: September 26, 2017
• Start date: February 2014
• Est. completion date: July 2016

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• 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 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital Vall D' Hebron	Barcelona
Spain	Hospital G.de Jerez de la Frontera	Cadiz
Spain	Hospital de Txagorritxu	Gasteiz / Vitoria
Spain	Hospital Universitario León	León	A/Altos de Nava s/n
Spain	Hospital de Mérida	Mérida
Spain	Hospital Univ. Virgen de la Arrixaca	Murcia
Spain	Hospital Parc Tauli	Sabadell
Spain	Complejo de Hospitalario de Santiago	Santiago de Compostela
Spain	Hospital Virgen del Rocio	Sevilla
Spain	Hospital Mutua de Terrassa	Terrassa
Spain	Hospital Clinico de Valencia	Valencia
Spain	Hospital Doctor Peset	Valencia
Spain	Hospital de Cruces	Vizcaya

Sponsors (1)

Lead Sponsor	Collaborator
C.E.M. Biotronik, S.A.

Country where clinical trial is conducted

Spain, 

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 months
Secondary	Target Vessel Revascularization (TVR)	Target Vessel Revascularization (TVR)	6 and 12 months
Secondary	Target lesion revascularization (TLR)	Target lesion revascularization (TLR)	6 and 12 months
Secondary	Stent Thrombosis rate	Stent Thrombosis rate	6 and 12 months
Secondary	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, without using any adjunctive device outside the assigned treatment strategy	up to discharge
Secondary	Procedure 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, 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.	up to 7 days after procedure