Status:
COMPLETED
Biorest Liposomal Alendronate With Stenting sTudy (BLAST)
Lead Sponsor:
BIOrest Ltd.
Collaborating Sponsors:
Baim Institute for Clinical Research
Cardiovascular Research Foundation, New York
Conditions:
Coronary Artery Stenosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 w...
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 s...
Eligibility Criteria
Inclusion
- Subject is eligible for percutaneous coronary intervention .
- Subject is an acceptable candidate for coronary artery bypass graft surgery.
- Subject has stable angina pectoris
- Subject is a candidate for elective stenting of up to 2 lesions.
Exclusion
- General
- Any planned elective surgery or percutaneous intervention within 6 months post-procedure.
- A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
- Subject requires a staged procedure of either the target or any non-target vessel within 9 months post-procedure.
- Any drug eluting stent (DES) deployment within the past 12 months.
- Any planned drug eluting stent (DES) deployment during the procedure associated with this study or within 3 months following the index procedure.
- Known hypersensitivity or contraindication to aspirin or clopidogrel or a sensitivity to contrast media, which cannot be adequately pre-medicated
- Concurrent medical condition with a life expectancy of less than 12 months.
- Documented left ventricular ejection fraction (LVEF) \< 25% at the most recent evaluation.
- 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.
- History of cerebrovascular accident or transient ischemic attack in the last 6 months.
- Leukopenia .
- Neutropenia
- Thrombocytopenia
- Serum creatinine level \>2.5 mg/dl within 7 days prior to index procedure.
- History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
- 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.
- History of severe:Gastrointestinal disease,Immunodeficiency,Bone diseases
- Angiographic Exclusion Criteria
- 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).
- Any previous stent placement within 15 mm (proximal or distal) of the target lesion(s).
- 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.
- Target lesion(s) exhibiting an intraluminal thrombus (occupying \>50% of the true lumen diameter) at any time.
- Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
- 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.).
- Target lesion(s) with side branches \> 2.0mm in diameter.
- Target lesion(s) involving a bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch).
- Target lesion(s) with severe calcification.
- Target vessel exhibiting excessive tortuosity that may impede stent delivery and deployment at target lesion(s).
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT00739466
Start Date
September 1 2008
End Date
December 1 2015
Last Update
January 20 2016
Active Locations (12)
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1
Hillel Yaffe Medical Center
Hadera, Israel, 38100
2
Bnei Zion Medical Center
Haifa, Israel, 31048
3
Rambam Health Care Campus
Haifa, Israel, 31096
4
Lady Davis Carmel Medical Center
Haifa, Israel, 34362