Clinical trial NCT01941290: BIOFLOW III Asia Registry Orsiro Stent System
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: BIOTRONIK Asia Pacific Pte Ltd
Sponsor class: INDUSTRY
First posted: 2013-09-13
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic Subjects requiring coronary revascularization with Drug eluting Stent (DES)

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).

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.

Eligibility 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).

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 6 months
measure: Clinically Driven Target Vessel Revascularization (TVR)
timeFrame: 6 and 12 months
measure: Clinically Driven Target Lesion Revascularization (TLR)
timeFrame: 6 and 12 months
measure: Stent Thrombosis rate using ARC definition
timeFrame: 12 months
measure: Clinical device success
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
measure: Clinical Procedure Success
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Manial
country: India
facility: KMC Manjpal
state: Karnataka
city: Bangalore
country: India
facility: Fortis Hospitals-Bannerghatta Road
city: Bangalore
country: India
facility: Fortis Hospitals Bannerghatta Road
city: Coimbatore
country: India
facility: GKNM Hospital
city: Lucknow
country: India
facility: Divine Heart and Multi-Specialty Hospital
city: Lucknow
country: India
facility: King George Medical University
city: Mohali
country: India
facility: Fortis Hospital
city: Mumbai
country: India
facility: Holy Family Hospital
city: New Delhi
country: India
facility: BLK Super Speciality Hospital
city: New Delhi
country: India
facility: Dharma Vira Heart Centre, Sir Ganga Ram Hospital
city: New Delhi
country: India
facility: Fortis Escort Heart Institute
city: Pune
country: India
facility: Ruby Hall Clinic
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Colombo
country: Sri Lanka
facility: Lanka Hospital
city: Colombo
country: Sri Lanka
facility: National Hospital of Sri Lanka
city: Colombo
country: Sri Lanka
facility: Sri Jaiewardenepura General Hospital
city: Hanoi
country: Vietnam
facility: Bach Mai Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Cho Ray Hospital
Study officials:
affiliation: Fortis Escorts Heart Institute
name: Upendra Kaul, Dr
role: PRINCIPAL_INVESTIGATOR
References: