Coronary Artery Stenosis
Conditions
Interventions
Product Name: Resten-MP
Product Code: AVI-4126
Pharmaceutical Form: Intravenous infusion
CAS Number: 267395-69-7
Current Sponsor code: AVI-4126
Other descriptive name: Resten-NG (injection)
Concentrat
Sponsors
AVI BioPharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is 18 years old or older 2. The subject is an acceptable candidate for PTCA, coronary artery stenting, and emergent CABG 3. The subject must have clinical evidence of ischemic heart disease or a positive functional study 4. The target lesion/vessel must meet the following criteria: a) The target lesion is a single de novo lesion that has not been previously treated with any interventional procedure. Only one lesion may be treated per subject. b) The target vessel must be a native coronary artery with a stenosis of greater or equal to 50% and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Candidates will be excluded from the study if any of the following conditions are present: 1. The subject has a documented left ventricular ejection fraction 90 degrees to reach the target lesion). 9. The target lesion has any one of the following characteristics: a) Lesion location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the LAD, LCX, or RCA; b) Involves a side branch > 2.0 mm in diameter c) Is at or distal to a 45 degree bend in the vessel; or d) Is moderately to severely calcified. 10. The subject has a history of a stroke or transient ischemic attack within the prior 6 months 11. The subject has an active peptic ulcer or has had upper GI bleeding within the prior 6 months 12. The subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. 13. The subject has a concurrent medical condition with a life expectancy of less than 12 months. 14. The subject has any previous or planned treatment with other anti-restenotic therapies including, but not limited to, brachytherapy in the target vessel within 30 days of the stent placement procedure[Note: Staged treatment of a non-target vessel is appropriate 30 days after enrollment]. 15. The subject is currently participating in an investigational drug or other device study that has not completed the primary endpoint or that clinically interferes with current study endpoints. 16. The subject is unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the potential efficacy of a 16 mg dose of Resten-MP given intravenously upon confirmation of stent implantation and again at 24 hours post stent implantation. The therapeutic endpoint to assess potential efficacy is the prevention of coronary late lumen loss 6 months after stent placement procedure, based on Quantitative Coronary Angiography (QCA).;Secondary Objective: To evaluate the safety and preliminary effectiveness of IV administration of Resten-MP compared to an Objective Performance Criteria for the following endpoints: - Major Cardiac Adverse Events (MACE) defined as cardiac death, MI (Q wave and non-Q wave), emergent cardiac bypass surgery, and clinically-driven target lesion revascularisation (TLR) at Days 14 and 30, and Month 6, 9 and 12 post-stent placement. - Target Vessel Failure (TVF) rate, defined as a composite of target vessel revascularization, recurrent MI (Q or non-Q wave), or cardiac death that could not be clearly attributed to a vessel other than the target vessel at Month 9 post-stent placement. - Angiographic binary restenosis (= 50% diameter stenosis), In-stent minimum lumen diameter (MLD), In-segment MLD, Proximal and distal late loss at month 6 post-stent placement -In-stent and in-segment percent (%) diameter stenosis at Month 6 post-stent placement.;Primary end point(s): The In-stent late loss at Month 6 as measured by quantitative coronary angiography (QCA), defined as the difference between minimal lumen diameter (MLD)immediately after stent placement and the MLD at 6 months after stent placement based on QCA | — |
Countries
Germany
Outcome results
None listed