Safety and Performance study in Diabetics with the Limus Eluting Orsiro Stent System in daily clinical practice

BIOTRONIK - SaFety and Performance Registry for an all-comers Diabetic patient population with the Limus Eluting Orsiro Stent System Within daily clinical practice - III - BIOFLOW-III Asia Registry

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2013/09/003967

Enrollment

880

Registered

2013-09-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diabetic Patients requiring Vascular Intervention with Drug Eluting Stent

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Diabetes Mellitus: Known Diabetic on Pharmacological treatment. ACS NSTEMI with documented Hb A1c >7%, even if not on Pharmacological treatment for diabetes. Subject is >= 18 years of age Patient has Symptomatic coronary artery disease Target lesion must be a de novo lesion located in a native coronary artery with reference vessel diameter >=2.25 mm & Patient should be receiving upto 3 stents and upto 2 stents per artery. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >=50% & =1. Subject provides signed informed consent for data release Subject is geographically stable and willing to comply with protocol required follow ups

Exclusion criteria

Exclusion criteria: Pregnant and/or breast-feeding females who intend to become pregnant during the period of the registry Untreatable 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. if the subject has a high probability that a procedure other than predilatation, stent implantation and post dilatation will be required at time of index procedure for treatment of target vessel (e.g. atherectomy, cutting balloon or brachytherapy). Patients admitted for treatment of Diabetic ketoacedosis >= 2 times in the past Six months (Brittle Diabetics).

Design outcomes

Primary

Measure	Time frame
Target Lesion Failure (TLF) at 12 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)Timepoint: 12 Month	—

Secondary

Measure	Time frame
TLF at 6 month follow up (FUP) (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)) Clinically driven Target Vessel Revascularization (TVR) at 6 and 12 months Clinically driven Target Lesion Revascularization (TLR) at 6 and 12 months Stent Thrombosis rate using ARC definition Clinical Device Success Clinical Procedural SuccessTimepoint: 6 and 12 Months	—

Measure

Time frame

TLF at 6 month follow up (FUP) (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)) Clinically driven Target Vessel Revascularization (TVR) at 6 and 12 months Clinically driven Target Lesion Revascularization (TLR) at 6 and 12 months Stent Thrombosis rate using ARC definition Clinical Device Success Clinical Procedural SuccessTimepoint: 6 and 12 Months

—

Countries

Bangladesh, India, Malaysia, Sri Lanka

Contacts

Public ContactShiv Issar

Fortis Escorts Heart Institute

upendra.kaul@fortishealthcare.com

Outcome results