BIOFLOW III Asia Registry Orsiro Stent System

NCT ID: NCT01941290

Last Updated: 2017-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 387 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-04-30

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Orsiro

No interventions assigned to this group

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BIOTRONIK Asia Pacific Pte Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Upendra Kaul, Dr

Role: PRINCIPAL_INVESTIGATOR

Fortis Escorts Heart Institute

Locations

Queen Mary Hospital

Hong Kong, , China

KMC Manjpal

Manial, Karnataka, India

Fortis Hospitals-Bannerghatta Road

Bangalore, , 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

Countries

China; India; Malaysia; Sri Lanka; Vietnam

Other Identifiers

G1206

Identifier Type: -

Identifier Source: org_study_id