This trial is active, not recruiting.

Condition coronary artery diseases
Sponsor Biotronik Italia S.p.A.
Start date February 2014
End date September 2016
Trial size 500 participants
Trial identifier NCT02028728, G1307


For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil 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 to 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 to 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 neontimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in 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.

Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the collection of clinical evidence for the clinical performance and

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

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: Up to discharge
Clinical procedural success
time frame: up to seven days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Symptomatic coronary artery disease - Subject signed informed consent for data release - Subject is geographically stable and willing to participate at all follow up assessments - Subject is ≥ 18 years of age Exclusion Criteria: - Subject did not sign informed consent - Pregnancy - Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media - Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained - Currently participating in another study and primary endpoint not reached yet

Additional Information

Official title Safety and Performance Registry for an All Comers Patient Population With the Limus Eluting Orsiro Stent Within Daily Clinical Practice III-Italy
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Biotronik Italia S.p.A..