BIOFLOW III Asia Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
BIOTRONIK Asia Pacific Pte Ltd
ClinicalTrials.gov Identifier:
NCT01941290
First received: September 3, 2013
Last updated: April 15, 2016
Last verified: April 2016
  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: 364
Study Start Date: September 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Locations
China
Queen Mary Hospital
Hong Kong, China
India
KMC Manjpal
Manipal, Karnataka, India
Fortis Hospitals-Bannerghatta Road
Bangalore, India, KA 560076
Fortis Hospitals Bannerghatta Road
Bangalore, India
GKNM Hospital
Coimbatore, India
King George Medical University
Lucknow, India
Divine Heart and Multi-Specialty Hospital
Lucknow, India
Fortis Hospital
Mohali, India
Holy Family Hospital
Mumbai, India
BLK Super Speciality Hospital
New Delhi, India
Batra Hospital and Research Centre
New Delhi, India, 110062
Dharma Vira Heart Centre, Sir Ganga Ram Hospital
New Delhi, India
Fortis Escort Heart Institute
New Delhi, India
Fortis Flt Lt Rejan Dhall Hospital
New Delhi, India
Ruby Hall Clinic
Pune, India
Malaysia
Institut Jantung Negara
Kuala Lumpur, Malaysia
Sri Lanka
Lanka Hospital
Colombo, Sri Lanka
National Hospital of Sri Lanka
Colombo, Sri Lanka
Sri Jaiewardenepura General Hospital
Colombo, Sri Lanka
Vietnam
Bach Mai Hospital
Hanoi, Vietnam
Cho Ray Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
BIOTRONIK Asia Pacific Pte Ltd
Investigators
Principal Investigator: Upendra Kaul, Dr Fortis Escorts Heart Institute
  More Information

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 15, 2016
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:
Diabetes Mellitus
Ischemia
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 27, 2016