Status:
COMPLETED
Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary Arteries
Lead Sponsor:
Sarepta Therapeutics, Inc.
Collaborating Sponsors:
Baim Institute for Clinical Research
Conditions:
Coronary Artery Disease
Coronary Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The process of re-narrowing of a coronary artery following a revascularization procedure such as angioplasty, begins at the time of the procedure. Restenosis has long been considered a major problem f...
Detailed Description
The process of restenosis, the re-narrowing of a coronary artery lumen following a revascularization procedure, begins at the time of percutaneous coronary intervention (PCI). Restenosis has long been...
Eligibility Criteria
Inclusion
- ≥ 18 years of age.
- An acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), coronary artery stenting, and emergent coronary artery bypass graft (CABG).
- Clinical evidence of ischemic heart disease or a positive functional study.
- The target lesion/vessel must meet the following criteria:
- 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.
- The target vessel must be a native coronary artery with a stenosis of ≥ 50% and \< 100%.
- The target lesion must be ≥ 10 mm and ≤ 30 mm in length.
- The target vessel reference diameter must be ≥ 2.5 mm and ≤ 4.0 mm.
- Female subjects of childbearing potential must have a documented negative serum pregnancy test within seven days before the procedure.
- The subject or the subject's legally authorized representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
- The subject is capable of providing informed consent and has provided written consent prior to study entry.
Exclusion
- Documented left ventricular ejection fraction \< 30%.
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, stainless steel, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- Evidence of an acute myocardial infarction within 72 hours of the intended treatment \[defined as: Q wave or non-Q wave infarction having creatine kinase (CK) enzymes ≥ 2 times the upper laboratory normal (with the presence of a CK-MB elevated above the Institution's upper limit of normal)\] or acute myocardial infarction in progress at time of treatment.
- Previous coronary interventional procedure of any kind within the 30 days prior to the stent-placement procedure.
- Planned interventional treatment of either the target or any non-target vessel within 30 days post-stent placement procedure is required.
- Target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, or rotational atherectomy).
- Previous stenting anywhere in the target vessel.
- Target vessel has evidence of thrombus or is excessively tortuous (2 bends \> 90° to reach the target lesion).
- Target lesion has any one of the following characteristics:
- Lesion location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX), or right coronary artery (RCA);
- Involves a side branch \> 2.0 mm in diameter;
- Is at or distal to a 45º bend in the vessel; or
- Is moderately to severely calcified.
- History of a stroke or transient ischemic attack within the prior 6 months.
- Active peptic ulcer or has had upper gastrointestinal (GI) bleeding within the prior 6 months.
- History of a bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Concurrent medical condition with a life expectancy of less than 12 months.
- Any previous or planned treatment with other anti-restenosis therapies including, but not limited to, brachytherapy in the target vessel within 30 days of the stent placement procedure. \[Note: Staged treatment of a non-target vessel is appropriate 30 days after enrollment.\]
- Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. \[Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.\]
- Unable to provide informed consent.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00248066
Start Date
September 1 2005
Last Update
February 8 2007
Active Locations (3)
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1
Coburg Hospital - Cardiology Clinic
Coburg, Germany
2
Cardiology Clinic, University Hospital of Essen
Essen, Germany
3
University Hospital of Heidelberg, Cardiology Clinic
Heidelberg, Germany