Status:
TERMINATED
A Phase 1b Study Evaluating RESTEN-MP in Subjects With Focal de Novo Stenosis
Lead Sponsor:
Sarepta Therapeutics, Inc.
Conditions:
Coronary Artery Disease
Coronary Stent Restenosis
Eligibility:
All Genders
19-80 years
Phase:
PHASE1
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 following a revascularization procedure, begins at the time of percutaneous coronary intervention (PCI). Restenosis has long been seen a major impediment of effective long-te...
Eligibility Criteria
Inclusion
- ≥ 19 and ≤ 80 years of age.
- The Subject must be properly consented following FDA regulations and guidelines.
- Male and Female volunteers with reproductive or childbearing potential must agree to practice adequate birth control methods to protect themselves and partners from conception .
- Subjects will be scheduled for percutaneous coronary intervention (PCI) due to first time implantation of a Taxus Express stent as a result of stenosis.
- Subject is an acceptable candidate for coronary artery bypass surgery.
- The Subject has no more than two lesions within the coronary arterial system requiring stent placement where the diameter of the affected artery or arteries is
- ≥ 2.5 mm and ≤ 4.9 mm based on angiography.
- The target lesion (and the secondary lesion, if applicable) is ≤ 20 mm in length via angiography.
- The Subject has had successful placement of a Taxus Express intracoronary stent(s).
- Subject agrees and is able to return for the scheduled study visits.
Exclusion
- One or more treatable lesions within the coronary arterial system requiring planned or staged intervention prior to the Month One visit.
- Multi-vessel coronary artery disease involving more than 2 vessels within the coronary arterial system requiring stent placement.
- Clinically significant findings for any body system that the Principal Investigator determines will exclude a Subject from safely participating in the study.
- A pregnant or nursing female.
- Positive history for HIV, HBV or HCV.
- In-stent restenosis in the target vessel.
- A target lesion located in an unprotected left main coronary artery or aorto-ostial location or in a bypass graft.
- Left ventricular ejection fraction \< 30%.
- Angiographic evidence of the target vessel segment angulated ≥ 45º.
- Angiographic evidence of thrombus or severe calcification in the target lesion.
- History of bleeding disorders or coagulopathy.
- NYHA Class III congestive heart failure (CHF).
- Serum creatinine \> 1.5 mg/dL.
- Clinically active cancer or any medical condition that may lead to study non-compliance or early study termination, confound the results, or is associated with limited life expectancy, i.e., less than 1 year.
- History of a stroke or trans-ischemic attack (TIA) within 6 months of angioplasty.
- Unstable ventricular arrhythmias.
- 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 ≥ 2X the upper laboratory normal with the presence of a CK-MB elevated above the upper limit of normal) or acute myocardial infarction in progress at time of treatment.
- Known hypersensitivity to aspirin, clopidogrel, or heparin or a contraindication to receive the contrast agent administered during angiographic procedures.
- Unwilling to accept blood transfusions.
- Participant in an investigational device or drug study 30 days prior to randomization in this study.
- A stent other than the Taxus Express is placed.
- Unsuccessful intracoronary stent placement.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00244647
Start Date
August 1 2003
Last Update
April 10 2008
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.