A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions (NCT01186198) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions
United States71 participantsStarted 2010-08-12
Plain-language summary
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject must be at least 18 years of age.
✓. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure.
✓. Subject must have stenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention.
✓. Subject must have single or multiple vessel coronary artery disease with clinical evidence of myocardial ischemia (e.g., stable or unstable angina or silent ischemia documented by a positive functional study).
✓. Subject must be an acceptable candidate for CABG.
✓. Subject must agree to undergo all protocol-required follow-up procedures.
✓. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure.
✓. De novo or restenotic lesions in native coronary arteries or bypass grafts.
Exclusion criteria
✕. Subject has had a known diagnosis of an acute myocardial infarction (AMI) within 72 hours preceding the intended index procedure.
✕. The subject is currently experiencing clinical symptoms consistent with a new onset of AMI, such as prolonged chest pain with ischemic ECG changes unresponsive to nitrates.
✕. Subject has hemodynamic instability or any hemodynamically unstable cardiac arrhythmias.
What they're measuring
1
Percentage of Participants With Procedure Success
Timeframe: On Day 0 (From the start to end of the interventional procedure)
✕. Subject has a known left ventricular ejection fraction (LVEF) \< 30% at the most recent evaluation (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
✕. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
✕. Subject will require Low Molecular Weight Heparin (LMWH) within 8 hours before or at any time after the index procedure.
✕. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-medicated.
✕. Subject has a platelet count \< 100,000 cells/mm\^3 or \> 700,000 cells/mm\^3.