BIOFLOW-III Romania Satellite Registry

This study has been terminated.
(low enrollment)
Sponsor:
Information provided by (Responsible Party):
Biotronik Vertriebs-GmbH
ClinicalTrials.gov Identifier:
NCT01593059
First received: May 4, 2012
Last updated: April 25, 2014
Last verified: August 2012
  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 Romania

Further study details as provided by Biotronik Vertriebs-GmbH:

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 and 18 months ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: Yes ]
    Any repeat revascularization of the target vessel.

  • Target Lesion Revascularization (TLR) [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: Yes ]
    Any repeat revascularization of the target lesion.

  • Stent Thrombosis [ Time Frame: 6, 12 and 18 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: 13
Study Start Date: August 2012
Study Completion Date: November 2013
Primary Completion Date: October 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
  • Elective PCI with DES

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: NCT01593059

Locations
Romania
University Hospital Bucharest
Bucharest, Romania
Cardiovascular Diseases Institute CC Iliescu
Bucharest, Romania
County Emergency Hospital
Cluj Napoca, Romania
Country Hospital
Targu Mures, Romania, 540136
Sponsors and Collaborators
Biotronik Vertriebs-GmbH
Investigators
Principal Investigator: Dragos Vinereanu, Prof. University Hospital Bucharest
  More Information

No publications provided

Responsible Party: Biotronik Vertriebs-GmbH
ClinicalTrials.gov Identifier: NCT01593059     History of Changes
Other Study ID Numbers: G1106
Study First Received: May 4, 2012
Last Updated: April 25, 2014
Health Authority: Romania: Ethics Committee

Keywords provided by Biotronik Vertriebs-GmbH:
International
Multicenter
Observational 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 September 18, 2014