Overview

This trial is active, not recruiting.

Conditions coronary artery disease, myocardial ischemia, diabetes mellitus type 1 or 2
Sponsor BIOTRONIK Asia Pacific Pte Ltd
Start date September 2013
End date April 2017
Trial size 364 participants
Trial identifier NCT01941290, G1206

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm

Primary Outcomes

Measure
Target Lesion Failure (TLF)
time frame: 12 months

Secondary Outcomes

Measure
Target Lesion Failure (TLF)
time frame: 6 months
Clinically Driven Target Vessel Revascularization (TVR)
time frame: 6 and 12 months
Clinically Driven Target Lesion Revascularization (TLR)
time frame: 6 and 12 months
Stent Thrombosis rate using ARC definition
time frame: 12 months
Clinical device success
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
Clinical Procedure Success
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 days

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

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
Principal investigator Upendra Kaul, Dr
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by BIOTRONIK Asia Pacific Pte Ltd.