Biorest Liposomal Alendronate With Stenting sTudy (BLAST)

Launched by BIOREST LTD. · Aug 20, 2008

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• 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 Exclusion Criteria
• • 1. Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the LAD or Circumflex artery or a branch thereof).
• • 2. Any previous stent placement within 15 mm (proximal or distal) of the target lesion(s).
• • 3. Target vessel exhibiting lesions with greater than 60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion(s) based on visual estimate or on-line QCA.
• • 4. Target lesion(s) exhibiting an intraluminal thrombus (occupying \>50% of the true lumen diameter) at any time.
• • 5. Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
• • 6. The target lesion(s) requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
• • 7. Target lesion(s) with side branches \> 2.0mm in diameter.
• • 8. Target lesion(s) involving a bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch).
• • 9. Target lesion(s) with severe calcification.
• • 10. Target vessel exhibiting excessive tortuosity that may impede stent delivery and deployment at target lesion(s).
• • 11. Target lesion(s) located in a native vessel distal to an anastomosis with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass.