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BIOFLOW-III VIP Russia Registry Orsiro Stent System

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ClinicalTrials.gov Identifier: NCT02247492
Recruitment Status : Recruiting
First Posted : September 25, 2014
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Biotronik Russia

Brief Summary:
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body inflammation status correlates with the clinical outcome.

Condition or disease
Coronary Artery Diseases

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 neointimal 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. 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.

Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body inflammation status correlates with the clinical outcome.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 36 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 and Vulnerable Inflammation Parameter Registry
Actual Study Start Date : April 14, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2021

Group/Cohort
Orsiro



Primary Outcome Measures :
  1. 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 :
  1. Target Lesion Failure (TLF) [ Time Frame: 6 and 36 months ]
    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)

  2. Target Vessel Revascularization (TVR) [ Time Frame: 6 and 36 months ]
    Any repeat revascularization of the target vessel.

  3. Target Lesion Revascularization (TLR) [ Time Frame: 6 and 36 months ]
    Defined as any repeat revascularization of the target lesion.

  4. Stent Thrombosis [ Time Frame: 6, 12 and 36 months ]
    Definite, Probable and Possible Stent Thrombosis

  5. Clinical Device Success [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 day ]
    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 and without use of device outside the assigned treatment strategy.

  6. Clinical procedural success [ Time Frame: up to seven days ]

    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 and without using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event during the hospital stay to a maximum of the first seven days post index procedure.

    In case of multiple lesions treatment, all treated lesions must meet the clinical procedural success.


  7. Vulnerable Inflammation Parameter (VIP) [ Time Frame: up to 36 months ]
    VIP registered ad Endotoxin concentration in patients blood serum



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)
Criteria

Inclusion Criteria:

  • Symptomatic coronary artery disease
  • Subject 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
  • Pregnancy
  • Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/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 not reached yet

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247492


Contacts
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Contact: Ildar Khassanov, Dr. +49 9131 852 56 34 ildar.khassanov@biotronik.com

Locations
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Russian Federation
Ural Institute of Cardiology Recruiting
Ekaterinburg, Russian Federation
Contact: Marina Freidlin         
Research Institute for Complex Problems of Cardiovascular Diseases Recruiting
Kemerovo, Russian Federation
Contact: Gonyukov, Dr.         
Regional Clinical Hospital Recruiting
Nizhniy Novgorod, Russian Federation
Contact: Antonina Bogush, Dr.         
Novosibirsk Scientific Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation
Contact: Evgeniy Kretov         
City Emergency Clinical Hospital of Rostov-on-Don Recruiting
Rostov-on-Don, Russian Federation
Contact: Alexander Ponomarev, Dr.         
North-West Federal Medical Research Center named after V.A. Almazov Recruiting
Saint Petersburg, Russian Federation
Contact: Alexey Yakovlev         
Institute of Cardiology, Tomsk Medical Research Recruiting
Tomsk, Russian Federation
Contact: Sergey Popov         
Sponsors and Collaborators
Biotronik Russia
Investigators
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Principal Investigator: Evgeny Kretov, Dr. Novosibirsk Research Institute for Circulation

Additional Information:

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Responsible Party: Biotronik Russia
ClinicalTrials.gov Identifier: NCT02247492     History of Changes
Other Study ID Numbers: G1406
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Keywords provided by Biotronik Russia:
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
Chronic Total Occlusion (CTO
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases