BIOFLOW-III All-comers Orsiro Safety and Performance Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01553526
First received: March 8, 2012
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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


Condition
Coronary Artery Disease
Myocardial Ischemia

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Biotronik AG:

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), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)


Secondary Outcome Measures:
  • Target Lesion Failure (TLF) [ Time Frame: 6, 36 and 60 months ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 6, 12, 36 and 60 months ] [ Designated as safety issue: Yes ]
    Any repeat revascularization of the target vessel.

  • Target Lesion Revascularization (TLR) [ Time Frame: 6, 12, 36 and 60 months ] [ Designated as safety issue: Yes ]
    Any repeat revascularization of the target lesion.

  • Stent Thrombosis [ Time Frame: 6, 12, 36 and 60 months ] [ Designated as safety issue: Yes ]
  • Clinical Device Success [ Time Frame: At time of intervention ] [ Designated as safety issue: No ]
  • Clinical Procedural Success [ Time Frame: During the hospital stay to a maximum of the first seven days post index procedure ] [ Designated as safety issue: Yes ]

Enrollment: 1356
Study Start Date: August 2011
Estimated Study Completion Date: June 2017
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Orsiro DES

Detailed Description:

For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil 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%-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%-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 immobilised on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a 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. This observational registry 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.

  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-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (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

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 of PCI unless dual antiplatelet therapy will be maintained
  • Currently participating in another study and primary endpoint is not reached yet.
  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: NCT01553526

  Show 42 Study Locations
Sponsors and Collaborators
Biotronik AG
Investigators
Study Director: Esther Gerteis Biotronik AG
Principal Investigator: Johannes Waltenberger, Prof. University Hospital Muenster
  More Information

No publications provided

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01553526     History of Changes
Other Study ID Numbers: C1101
Study First Received: March 8, 2012
Last Updated: November 5, 2013
Health Authority: Austria: Ethikkommission
Chile: Institutional Review Board
Denmark: National Board of Health
France: Conseil National de l'Ordre des Médecins
Germany: Ethics Commission
Ireland: Medical Ethics Research Committee
Italy: Ethics Committee
Latvia: Institutional Review Board
Netherlands: Medical Ethics Review Committee (METC)
Portugal: Ethics Committee for Clinical Research
Spain: Comité Ético de Investigación Clínica
Sweden: Regional Ethical Review Board
Switzerland: Ethikkommission
United Kingdom: National Health Service

Keywords provided by Biotronik AG:
International
Multicenter
Observational registry
All-comers open label registry
Orsiro Drug Eluting Stent (DES)
Stenting
Treatment of Coronary Artery Disease
Coronary revascularization
Percutaneous Coronary Intervention
STEMI
NSTEMI
Ischemia
Angina
Subgroups
Acute Myocardial Infarction
Diabetes
Small Vessels
Chronic Total Occlusion (CTO)

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

ClinicalTrials.gov processed this record on August 26, 2014