A Phase IIA Study to Evaluate the Safety and Preliminary Efficacy of Resten-MP when used in Conjunction with a Bare Metal Stent in de novo Native Coronary Artery Lesions - APPRAISA

Conditions: Coronary Artery Stenosis

Registration Number: EUCTR2005-000713-35-DE

Lead Sponsor: AVI BioPharma Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 50

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 < 100%.
c) The target lesion must be greater or equal to 10 mm and less than or equal to 30 mm in length
d) The target vessel reference diameter must be greater or equal to 2.5 mm and less than or equal to 4.0 mm.
5. Female subjects of childbearing potential must have a documented negative serum pregnancy test within 7 days before the procedure.
6. The subject or the subject's legal 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 or the respective clinical site.
7. The subject and the treating physician agree that the subject will return for all required post-procedural follow-up visits.
8. The subject is capable of providing informed consent and has provided written consent prior to study entry.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 < 30%
2. The subject has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, stainless steel, or sensitivity to contrast media, which cannot be adequately pre-medicated.
3. The subject has evidence of an acute myocardial infarction within 72 hours of the intended treatment [defined as: Q wave or non Q wave infarction having CK enzymes greater or equal to 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 the time of treatment.
4. The subject has had a previous coronary interventional procedure of any kind within the 30 days prior to stent placement procedure
5. The subject requires planned interventional treatment of either the target or any non-target vessel within 30 days post-stent placement procedure.
6. The 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.
7. The subject has had previous stenting anywhere in the target vessel.
8. The target vessel has evidence of thrombus or is excessively tortuous (2 bends > 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.