ACTRN12607000578404
Not yet recruiting
Phase 1
A prospective, randomized, multicenter study to evaluate the safety, efficacy and performance of the CardioMind Coronary Stent Systems for treatment of stenotic lesions in small diameter native coronary arteries.
CardioMind0 sites230 target enrollmentNovember 9, 2007
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Coronary artery disease
- Sponsor
- CardioMind
- Enrollment
- 230
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Suitable candidate for percutaneous coronary intervention (PCI) in a symptomatic native coronary vessel with a reference diameter of 2\.0 – 2\.75 mm and lesion length \< 20 mm. Treatment of one non\-target lesion in a separate epicardial vessel is allowed.
Exclusion Criteria
- •Need for treatment of a second lesion in the target vessel 30 days before or after the index procedure, excessive calcification or tortuosity, presence of thrombus or Thrombolysis in Myocardial Infarction (TIMI) flow \< 2, concomitant health conditions (renal insufficiency, recent stroke, myocardial infarction (MI) or gastrointestinal (GI) bleeding), pregnant, unable to comply with antiplatelet therapy, ostial lesions, low coronary reserve.
Outcomes
Primary Outcomes
Not specified
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