Coronary Artery Stenosis
Conditions
Keywords
Liposomal Alendronate, Percutaneous coronary intervention, Coronary stenting, de novo stenotic lesions, Native coronary arteries, Restenosis, Bare metal stent, Presillion CoCr coronary stent
Brief summary
The main objective of this study is to assess the safety and efficacy of Liposomal Alendronate in the treatment of de novo stenotic lesions in native coronary arteries in a population undergoing PCI with implantation of a bare metal stent. Study hypothesis: Liposomal Alendronate will reduce in-stent restenosis as compared to placebo.
Detailed description
This is a Phase II dose-finding, randomized, multi-center, prospective, double blind clinical study. Subjects undergoing percutaneous coronary intervention (PCI) with the Presillion™ CoCr bare metal stent will be randomized into three groups and administered (in a single dose intravenously (IV) through a peripheral venous catheter) either: low dose Liposomal Alendronate of 0.001 mg, high dose Liposomal Alendronate of 0.01 mg, or placebo (IV saline infusion) on a 1:1:1 basis. All subjects will undergo angiographic follow-up at 6 months and 110 subjects enrolled from pre-specified sites will undergo intravascular ultrasound (IVUS) at baseline and follow-up at 6 months.
Interventions
DRUGLiposomal Alendronate
IV in a single low dose during the index procedure (coronary stent implantation) over 2 hours
IV saline infusion during the index procedure (coronary stent implantation) over 2 hours
Sponsors
Baim Institute for Clinical Research
Cardiovascular Research Foundation, New York
Stanford University
BIOrest Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is eligible for percutaneous coronary intervention . 2. Subject is an acceptable candidate for coronary artery bypass graft surgery. 3. Subject has stable angina pectoris 4. Subject is a candidate for elective stenting of up to 2 lesions.
Exclusion criteria
General 1. Any planned elective surgery or percutaneous intervention within 6 months post-procedure. 2. A previous coronary interventional procedure of any kind within 30 days prior to the procedure. 3. Subject requires a staged procedure of either the target or any non-target vessel within 9 months post-procedure. 4. Any drug eluting stent (DES) deployment within the past 12 months. 5. Any planned drug eluting stent (DES) deployment during the procedure associated with this study or within 3 months following the index procedure. 6. Known hypersensitivity or contraindication to aspirin or clopidogrel or a sensitivity to contrast media, which cannot be adequately pre-medicated 7. Concurrent medical condition with a life expectancy of less than 12 months. 8. Documented left ventricular ejection fraction (LVEF) \< 25% at the most recent evaluation. 9. Evidence of ST elevated myocardial infarction (STEMI) or non-STEMI with troponin (cTn) levels greater than or equal to 3 times the normal limit at any time within 72 hours of the intended trial procedure. 10. History of cerebrovascular accident or transient ischemic attack in the last 6 months. 11. Leukopenia . 12. Neutropenia 13. Thrombocytopenia 14. Serum creatinine level \>2.5 mg/dl within 7 days prior to index procedure. 15. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions. 16. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel and ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy, Alendronate or sensitivity to contrast media, which cannot be adequately pre-medicated. 17. History of severe:Gastrointestinal disease,Immunodeficiency,Bone diseases Angiographic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent late loss: measured at 6 months post-procedure as determined by quantitative coronary angiography (QCA). | 6 months post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Events (MACE) | at 30, 180 and 360 days as well as yearly through 5 years post-procedure |
Countries
Israel
Outcome results
None listed