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

BIOFLOW III Asia Registry Orsiro Stent System

Sponsors

Lead sponsor: BIOTRONIK Asia Pacific Pte Ltd

Source BIOTRONIK Asia Pacific Pte Ltd
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.

Overall Status Completed
Start Date October 2013
Completion Date April 2017
Primary Completion Date April 2017
Study Type Observational
Primary Outcome
Measure Time Frame
Target Lesion Failure (TLF) 12 months
Secondary Outcome
Measure Time Frame
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
Clinical Procedure Success Participants will be followed for the duration of hospital stay, an expected average of 2 days
Enrollment 387
Condition
Eligibility

Sampling method: Non-Probability Sample

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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

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

China

India

Malaysia

Sri Lanka

Vietnam

Verification Date

September 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Orsiro

Study Design Info

Observational model: Other

Time perspective: Prospective

Source: ClinicalTrials.gov