BIOFLOW III Satellite-ELADIS Orsiro Stent System

NCT ID: NCT02029092

Last Updated: 2017-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 404 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-07-31

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Orsiro

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C.E.M. Biotronik, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonia Martin

Role: STUDY_DIRECTOR

CEM BIOTRONIK SA

Locations

Hospital Universitario León

León, A/Altos de Nava S/n, Spain

Hospital Infanta Cristina

Badajoz, , Spain

Hospital Vall D' Hebron

Barcelona, , Spain

Hospital G.de Jerez de la Frontera

Cadiz, , 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

Seville, , Spain

Hospital Mutua de Terrassa

Terrassa, , Spain

Hospital Clinico de Valencia

Valencia, , Spain

Hospital Doctor Peset

Valencia, , Spain

Hospital de Txagorritxu

Vitoria-Gasteiz, , Spain

Hospital de Cruces

Vizcaya, , Spain

Countries

Spain

Other Identifiers

G1302

Identifier Type: -

Identifier Source: org_study_id