BIOFLOW III Asia Registry Orsiro Stent System

NCT01941290 | Completed

• 1 other identifier: G1206
• Study Type: observational
• Target: 387
• Locations: 5 countries
• Sites: 19

Brief Summary

Cliflical evaluation of th' Orsiro LESS 10 diabetic subjects requiring coronary revasculariza t ion with Drug Eluting Stefl ts (DES) .880 subjects will be enrolled in this registry. The sample subjects size may be increased in order to reach the subgroup sizes (Small Vessel and AMI).

Conditions

Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus Type 1 or 2

Keywords

International; Multicenter; Observational registry; Orsiro Drug Eluting Stents (DES); Stenting; Treatment of Coronary Artery Disease; Coronary Revascularization; Percutaneous Coronary Intervention (PCI); Diabetes Mellitus Type 1; Diabetes Mellitus Type 2; STEMI; NSTEMI; Ischemia; Angina; Subgroups; Acute Myocardial Infarction; Small Vessels; Chronic Total Occlusion

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Secondary Outcomes (6)

• Target Lesion Failure (TLF)

  6 months

• Clinically Driven Target Vessel Revascularization (TVR)

  6 and 12 months

• Clinically Driven Target Lesion Revascularization (TLR)

  6 and 12 months

• Stent Thrombosis rate using ARC definition

  12 months

• Clinical device success

  Participants will be followed for the duration of hospital stay, an expected average of 2 days

Study Arms (1)

Orsiro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic Subjects requiring coronary revascularization with Drug eluting Stent (DES)

You may qualify if:

• Diabetes Mellitus:
• Known Diabetic on Pharmacological treatment.
• ACS NSTEMI with documented Hb A1c\> 7%, even if not on Pharmacological treatment for diabetes.
• 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 \& ≤4.00 mm, lesion length ≤40 mm by visual estimate
• Patient should be receiving up to 3 stents and up to 2 stents per artery.
• Target lesion must be in a major coronary artery or branch with visually estimated stenosis ≥50% \& \<100% with TIMI flow≥1.
• Subject provides signed informed consent for data release
• Subject is geographically stable and willing to comply with protocol required follow ups
• Subject is ≥ 18 years of age

You may not qualify if:

• 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 ketoacidosis ≥ 2 times in the past Six months (Brittle Diabetics).

Sponsors & Collaborators

• BIOTRONIK Asia Pacific Pte Ltd: lead

Study Sites (19)

Queen Mary Hospital

Hong Kong, China

Location

KMC Manjpal

Manial, Karnataka, India

Location

Fortis Hospitals-Bannerghatta Road

Bangalore, KA 560076, India

Location

Fortis Hospitals Bannerghatta Road

Bangalore, India

Location

GKNM Hospital

Coimbatore, India

Location

Divine Heart and Multi-Specialty Hospital

Lucknow, India

Location

King George Medical University

Lucknow, India

Location

Fortis Hospital

Mohali, India

Location

Holy Family Hospital

Mumbai, India

Location

BLK Super Speciality Hospital

New Delhi, India

Location

Dharma Vira Heart Centre, Sir Ganga Ram Hospital

New Delhi, India

Location

Fortis Escort Heart Institute

New Delhi, India

Location

Ruby Hall Clinic

Pune, India

Location

Institut Jantung Negara

Kuala Lumpur, Malaysia

Location

Lanka Hospital

Colombo, Sri Lanka

Location

National Hospital of Sri Lanka

Colombo, Sri Lanka

Location

Sri Jaiewardenepura General Hospital

Colombo, Sri Lanka

Location

Bach Mai Hospital

Hanoi, Vietnam

Location

Cho Ray Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Ischemia; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Myocardial Infarction; Infarction; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Upendra Kaul, Dr

  Fortis Escorts Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 13, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

SR (3); VN (2); CN (1); IN (12); MY (1)