A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions

A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions

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.

Inclusion Criteria:

General Inclusion Criteria

1. Subject must be at least 18 years of age.
2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure.
3. Subject must have stenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention.
4. 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).
5. Subject must be an acceptable candidate for CABG.
6. Subject must agree to undergo all protocol-required follow-up procedures.
7. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure.

Angiographic Inclusion Criteria

All angiographic inclusion criteria are based on visual estimation.

1. De novo or restenotic lesions in native coronary arteries or bypass grafts.
2. A maximum of two lesions, including at least one target lesion, in up to two major epicardial distribution trees. Tandem lesions, defined as multiple, focal lesions that can be covered by one stent, will be considered as a single lesion.
3. If one target lesion and one non-target lesion are to be treated, the target and non-target lesions must be located in different major epicardial distribution trees.
4. The target lesion must have a diameter stenosis of ≥ 70% by visual estimation or online quantitative coronary angiography (QCA), which may include chronic total occlusion (CTO).
5. Lesions may be located in highly tortuous vessels.

Exclusion Criteria:

General Exclusion Criteria

1. Subject has had a known diagnosis of an acute myocardial infarction (AMI) within 72 hours preceding the intended index procedure.
2. 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.
3. Subject has hemodynamic instability or any hemodynamically unstable cardiac arrhythmias.
4. 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).
5. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
6. Subject will require Low Molecular Weight Heparin (LMWH) within 8 hours before or at any time after the index procedure.
7. 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.
8. Subject has a platelet count < 100,000 cells/mm^3 or > 700,000 cells/mm^3.
9. Subject has a serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
10. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
11. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
12. Subject has had active peptic ulcer or a significant gastrointestinal or urinary bleed within the past six months.
13. Elective surgery is planned during hospitalization for the index procedure that will require discontinuing dual anti-platelet therapy.
14. Subject has other medical illness (e.g., cancer) that may confound the data interpretation or is associated with a limited life expectancy.
15. Subject is currently participating in an investigational study when such participation could confound the treatment or outcomes of this study.
16. Subject is pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Angiographic Exclusion Criteria

All angiographic exclusion criteria are based on visual estimation.

1. More than two lesions require treatment. Tandem lesions, defined as multiple, focal lesions that can be covered by one stent, will be considered as a single lesion.
2. Target lesion is located in an unprotected left main artery.
3. Coronary artery spasm in the absence of significant stenosis.
4. Target vessel contains thrombus as indicated in the initial angiographic images.
5. During the index procedure, any lesion requires additional treatment with any adjunctive or ablative device (i.e., rotational or directional atherectomy, cutting balloon, laser, thrombectomy, etc.).
6. Target lesion involving a bifurcation with a side branch ≥ 2.5 mm in diameter, with an ostial lesion > 40% stenosed, or with a side branch requiring protection guide wire or pre-dilatation.
7. Additional clinically significant lesion(s) in any coronary arteries or bypass grafts for which PCI may be required during hospitalization for the index procedure.