N/A
Completed N=440
BIOTRONIK Orsiro Pre-Marketing Registration
Source: ClinicalTrials.gov NCT02870985 ↗Enrolled (actual)
440
Serious AEs
37.3%
Results posted
Mar 2024
Primary outcomePrimary: In-stent Late Lumen Loss at 9 Months as Assessed by the Core Laboratory QCA Analysis — 0.05; 0.07 mm
Summary
The clinical investigation is a non-inferiority, multicenter, blinding evaluation, randomized, parallel controlled clinical study enrolling up to 440 subjects. All subjects will be randomized 1:1 to receive the BIOTRONIK Orsiro SES or the Abbott Xience Prime™ EES, in order to evaluate the efficacy and safety of the SES drug eluting stent in the treatment of coronary artery disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-stent Late Lumen Loss at 9 Months as Assessed by the Core Laboratory QCA Analysis |
0.05; 0.07 | — |
| SECONDARY Number of Participants With Main Adverse Cardiac Event (MACE) |
17; 13 | — |
| SECONDARY Number of Participants With All-cause Death |
6; 6 | — |
| SECONDARY Number of Participants With Cardiac Death |
2; 0 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
7; 3 | — |
| SECONDARY Number of Participants With TVR Myocardial Infarction |
4; 2 | — |
| SECONDARY In-stent Thrombus |
1; 0 | — |
| SECONDARY Number of Participants With TLR |
4; 4 | — |
Eligibility Criteria
Inclusion Criteria-Clinical
- Subject who can understand the investigation's goal has provided written informed consent, and is willing to comply with the study's follow-up requirements.
- Subject is ≥ 18 years and ≤ 75 years old, male or female without pregnant.
- Subject is an acceptable candidate for PCI.
- Subject has clinical evidence of asymptomatic ischemia, stable or unstable angina pectoris or old myocardial infarction.
- Subject has no contraindication for dual anti-platelet therapy treatment.
Inclusion Criteria-Angiographic
- Target lesion must be in the major coronary artery or a branch (target vessel).
- Target lesion must have angiographic evidence of ≥ 70% and 2.0 mg/dL or 175 μmol/L determined) within 7 days prior to the index procedure.
- Subject has leukopenia (i.e. WBC 350*10*9/L).
- Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent).
- Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are excluded), or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is excluded).
- Subject has a life expectancy of 2.5 mm in diameter. Note: Lesions within 3 mm of the origin of the right coronary artery may be treated.
- Target lesion is totally occluded (100% stenosis).
- Target vessel has angiographic evidence of thrombus.
- Target vessel/lesion is excessively tortuous/angulated or is severely calcified, preventing complete inflation of an angioplasty balloon.
- Target vessel was treated with brachytherapy at any time prior to the index procedure.
Data sourced from ClinicalTrials.gov (NCT02870985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.