BIOFLOW-III VIP Russia Registry Orsiro Stent System

Sponsor

Biotronik Russia (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02247492

Collaborator

(none)

200

Enrollment

Locations

48.6

Anticipated Duration (Months)

28.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Other

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 and Vulnerable Inflammation Parameter Registry

Actual Study Start Date :

Apr 14, 2017

Anticipated Primary Completion Date :

Apr 1, 2019

Anticipated Study Completion Date :

May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Orsiro

Outcome Measures

Primary Outcome Measures

Target Lesion Failure (TLF) [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

Target Lesion Failure (TLF) [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)
Target Vessel Revascularization (TVR) [6 and 36 months]
Any repeat revascularization of the target vessel.
Target Lesion Revascularization (TLR) [6 and 36 months]
Defined as any repeat revascularization of the target lesion.
Stent Thrombosis [6, 12 and 36 months]
Definite, Probable and Possible Stent Thrombosis
Clinical Device Success [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.
Clinical procedural success [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.
Vulnerable Inflammation Parameter (VIP) [up to 36 months]
VIP registered ad Endotoxin concentration in patients blood serum

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Ural Institute of Cardiology	Ekaterinburg	Russian Federation
2	Research Institute for Complex Problems of Cardiovascular Diseases	Kemerovo	Russian Federation
3	Regional Clinical Hospital	Nizhniy Novgorod	Russian Federation
4	Novosibirsk Scientific Research Institute of Circulation Pathology	Novosibirsk	Russian Federation
5	City Emergency Clinical Hospital of Rostov-on-Don	Rostov-on-Don	Russian Federation
6	North-West Federal Medical Research Center named after V.A. Almazov	Saint Petersburg	Russian Federation
7	Institute of Cardiology, Tomsk Medical Research	Tomsk	Russian Federation