BIOFLOW III Satellite-ELADIS

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by C.E.M. Biotronik, S.A.
Sponsor:
Information provided by (Responsible Party):
C.E.M. Biotronik, S.A.
ClinicalTrials.gov Identifier:
NCT02029092
First received: December 19, 2013
Last updated: April 14, 2014
Last verified: February 2014
  Purpose

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.


Condition
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

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

Primary Outcome Measures:
  • Target Lesion Failure (TLF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization (TLR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis rate [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Device success [ Time Frame: up to discharge ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All subjects requiring coronary revascularization with Drug Eluting Stents (DES)

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02029092

Contacts
Contact: Leticia Mora, Lead Field Clinical Research E +34 636 175 335 leticia.mora@biotronik.com
Contact: Sonia Martin, Clincal Manager +34 649 845298 sonia.martin@biotronik.com

Locations
Spain
Hospital Universitario León Recruiting
León, A/Altos de Nava s/n, Spain, 24080
Contact: Rodrigo Estevez Loureiro, Dr    +34987237683      
Principal Investigator: Rodrigo Estevez Loureiro, Dr         
Complejo hospitalario de Navarra Not yet recruiting
Pamplona, Navarra, Spain, 31008
Contact: Armando Pérez de Prado, Dr         
Principal Investigator: Armando Pérez de Prado, Dr         
Hospital Univ. Virgen de la Arrixaca Recruiting
Morcia, Spain
Contact: Mariano Valdes, Dr.         
Principal Investigator: Mariano Valdes, Dr.         
Complejo de Hospitalario de Santiago Recruiting
Santiago de Compostela, Spain, 15702
Contact: Ramiro Trillo, Dr    +34981950000    ramirotrillo@mac.com   
Principal Investigator: Ramiro Trillo, Dr         
Hospital de Txagorritxu Recruiting
Vitoria-Gasteiz, Spain
Contact: Alfonso Torres, Dr.         
Principal Investigator: Alfonso Torres, Dr.         
Hospital de Cruces Recruiting
Vizcaya, Spain, 48903
Contact: Luis Fernandez, Dr         
Principal Investigator: Luis Fernandez, Dr         
Sponsors and Collaborators
C.E.M. Biotronik, S.A.
  More Information

No publications provided

Responsible Party: C.E.M. Biotronik, S.A.
ClinicalTrials.gov Identifier: NCT02029092     History of Changes
Other Study ID Numbers: G1302
Study First Received: December 19, 2013
Last Updated: April 14, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

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

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014