BIOFLOW III Asia Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by BIOTRONIK Asia Pacific Pte Ltd
Sponsor:
Information provided by (Responsible Party):
BIOTRONIK Asia Pacific Pte Ltd
ClinicalTrials.gov Identifier:
NCT01941290
First received: September 3, 2013
Last updated: April 8, 2014
Last verified: February 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by BIOTRONIK Asia Pacific Pte Ltd:

Primary Outcome Measures:
  • Target Lesion Failure (TLF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • Target Lesion Failure (TLF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Clinically Driven Target Lesion Revascularization (TLR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis rate using ARC definition [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Clinical device success [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 days ] [ Designated as safety issue: No ]
    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.

  • Clinical Procedure Success [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 days ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 880
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941290

Contacts
Contact: Shiv Issar +91.11.40587850 ext 106 shiv.issar@biotronik.com

Locations
India
Fortis Hospitals-Bannerghatta Road Not yet recruiting
Bangalore, India, KA 560076
Contact: Dr Keshava , Dr       rkeshava@hotmail.com   
Principal Investigator: Dr Keshava, Dr         
Fortis Hospitals Bannerghatta Road Not yet recruiting
Bangalore, India
Contact: Rajpal Singh, Dr       singhrajpal@hotmail.com   
Principal Investigator: Rajpal Singh, Dr         
GKNM Hospital Not yet recruiting
Coimbatore, India
Contact: Rajpal Abhaichand, Dr       rajtrials@yahoo.com   
Principal Investigator: Rajpal Abhaichand, Dr         
Fortis Escorts Hospital Not yet recruiting
Jaipur, India
Contact: Dr Sanjeeb Roy       sanjeeb.roy@fortishealthcare.com   
Principal Investigator: Sanjeeb Roy, Dr         
Caritas Hospital Not yet recruiting
Kochi, India
Contact: Deepak Davidson, Dr       deepakdavidson@yahoo.com   
Principal Investigator: Deepak Davidson, Dr         
King George Medical University Recruiting
Lucknow, India
Contact: Sharad Chandra, Dr       sharadchandra_2612@yahoo.co.in   
Principal Investigator: Sharad Chandra, Dr         
Fortis Escorts Hospital Not yet recruiting
Mohali, India
Contact: Dr Arun Chopra, Dr       akchopra@rediffmail.com   
Principal Investigator: Arun Chopra, Dr         
Fortis Hospital Recruiting
Mohali, India
Contact: RK Jaswal, Dr       rakesh.jaswal@fortishealthcare.com   
Principal Investigator: RK Jaswal, Dr         
Holy Family Hospital Recruiting
Mumbai, India
Contact: Dr Brian Pinto       briampinto@iifcinfoo.com   
Principal Investigator: Brian Pinto, Dr         
Dharma Vira Heart Centre, Sir Ganga Ram Hospital Recruiting
New Delhi, India
Contact: Dr Rajneesh Jain       jainsaniya@yahoo.com   
Principal Investigator: Rajneesh Jain, Dr         
Batra Hospital and Research Centre Recruiting
New Delhi, India, 110062
Contact: Rajiv Agarwal, Dr.       rajiv.agaral162@gmail.com   
Principal Investigator: Rajiv Agarwal, Dr         
BLK Super Speciality Hospital Recruiting
New Delhi, India
Contact: Dr Neeraj Bhalla       drneerajbhalla@blkhosptal.com   
Principal Investigator: Neeraj Bhalla, Dr         
Deenanath Mangeshkar Hospital and Research Centre Not yet recruiting
Pune, India
Contact: Dr Shireesh Sathe       shireesh.sathe@gmail.com   
Principal Investigator: Shireesh Sathe, Dr         
Sponsors and Collaborators
BIOTRONIK Asia Pacific Pte Ltd
Investigators
Principal Investigator: Upendra Kaul, Dr Fortis Escorts Heart Institute
  More Information

No publications provided

Responsible Party: BIOTRONIK Asia Pacific Pte Ltd
ClinicalTrials.gov Identifier: NCT01941290     History of Changes
Other Study ID Numbers: G1206
Study First Received: September 3, 2013
Last Updated: April 8, 2014
Health Authority: India: Drugs Controller General of India

Keywords provided by BIOTRONIK Asia Pacific Pte Ltd:
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 1
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014