This trial is active, not recruiting.

Conditions coronary artery disease, myocardial ischemia
Sponsor Biotronik Hungária Kft.
Start date September 2012
End date September 2016
Trial size 2000 participants
Trial identifier NCT01892917, G1217


This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES)

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Target Lesion Failure (TLF)
time frame: 12 months

Secondary Outcomes

Target Lesion Failure
time frame: 6 and 18 months
Target Vessel Revascularization (TVR)
time frame: 6, 12 and 18 months
Target Lesion Revascularization (TLR)
time frame: 6, 12 and 18 months
Stent Thrombosis
time frame: 6, 12 and 18 months
Clinical Device Success
time frame: At time of intervention
Clinical Procedural Success
time frame: During the hospital stay to a maximum of the first seven days post index procedure

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Symptomatic coronary artery disease - Subject has signed informed consent for data release - Subject is geographically stable and willing to participate at all follow-up assessments - Subject is ≥ 18 years Exclusion Criteria: - Subject did not sign informed consent for data release - Pregnancy - Known 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

Additional Information

Official title BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III Hungary
Principal investigator Béla Merkely, Prof.
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 immobilised 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. This observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Biotronik Hungária Kft..