BIOFLOW-III VIP Russia Registry Orsiro Stent System

Coronary Artery Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02247492
• Other study ID #: G1406
• Status: Recruiting
• Start date: April 14, 2017
• Est. completion date: May 2021

Study information

• Verified date: July 2018
• Source: Biotronik Russia
• Contact: Ildar Khassanov, Dr.
• Phone: +49 9131 852 56 34
• Email: ildar.khassanov[@]biotronik.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2021
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Diseases
• Coronary Disease
• Myocardial Ischemia

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure (TLF)	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).	12 months
Secondary	Target Lesion Failure (TLF)	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)	6 and 36 months
Secondary	Target Vessel Revascularization (TVR)	Any repeat revascularization of the target vessel.	6 and 36 months
Secondary	Target Lesion Revascularization (TLR)	Defined as any repeat revascularization of the target lesion.	6 and 36 months
Secondary	Stent Thrombosis	Definite, Probable and Possible Stent Thrombosis	6, 12 and 36 months
Secondary	Clinical Device Success	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.	participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary	Clinical procedural success	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.	up to seven days
Secondary	Vulnerable Inflammation Parameter (VIP)	VIP registered ad Endotoxin concentration in patients blood serum	up to 36 months