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 range
18 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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.
. 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.