BIOFLOW III Asia Registry Orsiro Stent System

Biotronik-Safety and Performance Registry for an All-comers Diabetic Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice-III Asia

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).

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Diabetes Mellitus Type 1 or 2

Detailed Description

For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil 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%-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%-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 a 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.

An interesting group of analysis resulted to be diabetic patients. It has been concluded that the incidence of both nonocclusive and occlusive restenosis is higher in diabetic subjects after stenting as judged from comparison with historical control subjects. Results implicate accelerated restenosis as both a consequence of diabetes and a cause for increased mortality after PCI in diabetic patient.

Therefore this observational registry has been designed for the clinical evaluation of the Orsiro LESS in diabetic subjects (Diabetic patients type 1 or 2) requiring coronary revascularization with Drug Eluting Stents (DES). Results will contribute to the collection of clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in daily clinical practice.

• Study Type: Observational
• Enrollment (Actual): 387

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Queen Mary Hospital
• India
  • Bangalore, India, KA 560076
    • Fortis Hospitals-Bannerghatta Road
  • Bangalore, India
    • Fortis Hospitals Bannerghatta Road
  • Coimbatore, India
    • GKNM Hospital
  • Lucknow, India
    • King George Medical University
  • Lucknow, India
    • Divine Heart and Multi-Specialty Hospital
  • Mohali, India
    • Fortis Hospital
  • Mumbai, India
    • Holy Family Hospital
  • New Delhi, India
    • Fortis Escort Heart Institute
  • New Delhi, India
    • BLK Super Speciality Hospital
  • New Delhi, India
    • Dharma Vira Heart Centre, Sir Ganga Ram Hospital
  • Pune, India
    • Ruby Hall Clinic
  • Karnataka
    • Manial, Karnataka, India
      • KMC Manjpal
• Malaysia
  • Kuala Lumpur, Malaysia
    • Institut Jantung Negara
• Sri Lanka
  • Colombo, Sri Lanka
    • Lanka Hospital
  • Colombo, Sri Lanka
    • National Hospital of Sri Lanka
  • Colombo, Sri Lanka
    • Sri Jaiewardenepura General Hospital
• Vietnam
  • Hanoi, Vietnam
    • Bach Mai Hospital
  • Ho Chi Minh City, Vietnam
    • Cho Ray Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.
• 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

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Orsiro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 months
Clinically Driven Target Vessel Revascularization (TVR)	Any repeat revascularization of the target vessel.	6 and 12 months
Clinically Driven Target Lesion Revascularization (TLR)	Any repeat revascularization of the target lestion.	6 and 12 months
Stent Thrombosis rate using ARC definition	Definite, Probable and Possible Stent ThrombOsis	12 months
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 a device outside the assigned treatment strategy.	Participants will be followed for the duration of hospital stay, an expected average of 2 days
Clinical Procedure 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% of the target lesion as observed by visual estimate without using any adjunctive device* without the occurrence of ischemia-driven major adverse cardiac event (ID-MACE) 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. * Apart from post-dilatation with a non-compliant balloon	Participants will be followed for the duration of hospital stay, an expected average of 2 days

Collaborators and Investigators

• Sponsor: BIOTRONIK Asia Pacific Pte Ltd
• Investigators: Principal Investigator: Upendra Kaul, Dr, Fortis Escorts Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: September 3, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Actual): September 28, 2017
• Last Update Submitted That Met QC Criteria: September 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; STEMI; Angina; Ischemia; Chronic Total Occlusion; International; NSTEMI; Diabetes Mellitus Type 2; Multicenter; Diabetes Mellitus Type 1; Coronary Revascularization; Percutaneous Coronary Intervention (PCI); Observational registry; Stenting; Treatment of Coronary Artery Disease; Subgroups; Small Vessels; Orsiro Drug Eluting Stents (DES)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Autoimmune Diseases; Endocrine System Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 1; Ischemia
• Other Study ID Numbers: G1206