BIOFLOW-III VIP Russia Registry Orsiro Stent System

Last updated: July 19, 2018
Sponsor: Biotronik Russia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Chest Pain

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT02247492
G1406
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Symptomatic coronary artery disease

  • Subject signed informed consent for data release

  • Subject is geographically stable and willing to participate at all follow upassessments

  • Subject is ≥ 18 years of age

Exclusion

Exclusion Criteria:

  • Subject did not sign informed consent

  • Pregnancy

  • Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any otheranticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus orcontrast media

  • Planned surgery within 6 months after PCI unless dual antiplatelet therapy will bemaintained

  • Currently participating in another study and primary endpoint not reached yet

Study Design

Total Participants: 200
Study Start date:
April 14, 2017
Estimated Completion Date:
May 31, 2021

Study 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.

Connect with a study center

  • Ural Institute of Cardiology

    Ekaterinburg,
    Russian Federation

    Active - Recruiting

  • Research Institute for Complex Problems of Cardiovascular Diseases

    Kemerovo,
    Russian Federation

    Active - Recruiting

  • Federal Centre for Cardiovascular Surgery

    Krasnoyarsk,
    Russian Federation

    Site Not Available

  • Regional Clinical Hospital

    Nizhniy Novgorod,
    Russian Federation

    Active - Recruiting

  • Novosibirsk Scientific Research Institute of Circulation Pathology

    Novosibirsk,
    Russian Federation

    Active - Recruiting

  • Regional Clinical Hospital

    Orenburg,
    Russian Federation

    Site Not Available

  • City Emergency Clinical Hospital of Rostov-on-Don

    Rostov-on-Don,
    Russian Federation

    Active - Recruiting

  • North-West Federal Medical Research Center named after V.A. Almazov

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Institute of Cardiology, Tomsk Medical Research

    Tomsk,
    Russian Federation

    Active - Recruiting

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