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This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
C.E.M. Biotronik, S.A. Identifier:
First received: December 19, 2013
Last updated: September 7, 2015
Last verified: September 2015

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.

Coronary Artery Disease

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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

Resource links provided by NLM:

Further study details as provided by C.E.M. Biotronik, S.A.:

Primary Outcome Measures:
  • Target Lesion Failure (TLF) [ Time Frame: 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:
  • TLF [ Time Frame: 6 months ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 6 and 12 months ]
  • Target lesion revascularization (TLR) [ Time Frame: 6 and 12 months ]
  • Stent Thrombosis rate [ Time Frame: 6 and 12 months ]
  • Device success [ Time Frame: 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 [ Time Frame: 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.

Estimated Enrollment: 400
Study Start Date: February 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects requiring coronary revascularization with Drug Eluting Stents (DES)

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02029092

Hospital Universitario León
León, A/Altos de Nava s/n, Spain, 24080
Hospital Infanta Cristina
Badajoz, Spain
Hospital Vall D' Hebron
Barcelona, Spain
Hospital Jerez de la Frontera
Cadiz, Spain
Hospital Univ. Virgen de la Arrixaca
Morcia, Spain
Hospital de Mérida
Mérida, Spain
Hospital Parc Tauli
Sabadell, Spain
Complejo de Hospitalario de Santiago
Santiago de Compostela, Spain, 15702
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 Txagorritxu
Vitoria-Gasteiz, Spain
Hospital de Cruces
Vizcaya, Spain, 48903
Sponsors and Collaborators
C.E.M. Biotronik, S.A.
  More Information

Responsible Party: C.E.M. Biotronik, S.A. Identifier: NCT02029092     History of Changes
Other Study ID Numbers: G1302
Study First Received: December 19, 2013
Last Updated: September 7, 2015

Keywords provided by C.E.M. Biotronik, S.A.:
Observational registry
Orsiro Drug Eluting Stent (DES)
Treatment of coronary artery disease
Coronary revascularization
Percutaneous Coronary Intervention (PCI)
Acute Myocardial Infarction (AMI)
Small Vessels
Chronical Total Occlusion (CTO)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on April 27, 2017