- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01186198
A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions (CROSS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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La Jolla, California, United States, 92037
- Scripps Green Hospital
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Maryland
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Salisbury, Maryland, United States, 21804
- Peninsula Regional Medical Center
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Michigan
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Petoskey, Michigan, United States, 49770
- Northern Michigan Hospital
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Ohio
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Cincinnati, Ohio, United States, 45219
- The Christ Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
General 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.
Angiographic Inclusion Criteria
All angiographic inclusion criteria are based on visual estimation.
- De novo or restenotic lesions in native coronary arteries or bypass grafts.
- 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.
- 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.
- 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).
- Lesions may be located in highly tortuous vessels.
Exclusion Criteria:
General 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.
- Subject has a serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
- Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
- Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Subject has had active peptic ulcer or a significant gastrointestinal or urinary bleed within the past six months.
- Elective surgery is planned during hospitalization for the index procedure that will require discontinuing dual anti-platelet therapy.
- Subject has other medical illness (e.g., cancer) that may confound the data interpretation or is associated with a limited life expectancy.
- Subject is currently participating in an investigational study when such participation could confound the treatment or outcomes of this study.
- 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.
- 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.
- Target lesion is located in an unprotected left main artery.
- Coronary artery spasm in the absence of significant stenosis.
- Target vessel contains thrombus as indicated in the initial angiographic images.
- 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.).
- 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.
- Additional clinically significant lesion(s) in any coronary arteries or bypass grafts for which PCI may be required during hospitalization for the index procedure.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
MINI TREK RX 1.20 mm Coronary Dilatation Catheter
Patients requiring initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis will be included.
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Enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Procedure Success
Time Frame: On Day 0 (From the start to end of the interventional procedure)
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Procedure success was defined as meeting all the following after single or multiple attempts:
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On Day 0 (From the start to end of the interventional procedure)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Device Success
Time Frame: On Day 0 (From the start to end of the interventional procedure)
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Device Success was defined as meeting all the following after single or multiple attempts:
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On Day 0 (From the start to end of the interventional procedure)
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Rate of Lesion Success
Time Frame: On Day 0 (From the start to end of the interventional procedure)
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Lesion Success was defined as meeting all the following after single or multiple attempts:
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On Day 0 (From the start to end of the interventional procedure)
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Rate of Individual Procedural Parameters
Time Frame: On Day 0 (From the start to end of the interventional procedure)
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The following parameters were assessed by either an angiographic core laboratory or the investigator at the site
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On Day 0 (From the start to end of the interventional procedure)
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Rate of Major Adverse Cardiac Event (MACE)
Time Frame: In-Hospital (1 - 3 Days)
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In-hospital MACE was defined as the composite of all deaths, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR) by coronary artery bypass graft surgery (CABG) or PCI during the hospitalization for the index procedure
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In-Hospital (1 - 3 Days)
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Rate of Target Lesion Failure (TLF)
Time Frame: In-Hospital (1 - 3 Days)
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In-hospital TLF was defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR by CABG or PCI during the hospitalization for the index procedure
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In-Hospital (1 - 3 Days)
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Rate of Stent Thrombosis
Time Frame: In-Hospital (1 - 3 Days)
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Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Angiographic confirmation involves presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent and presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest; New ischemic ECG changes that suggest acute ischemia; Typical rise and fall in cardiac biomarkers; Non-occlusive; Occlusive thrombus Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy is a pathological confirmation. Probable stent thrombosis is considered to have occur after intracoronary stenting in case of any unexplained death within the first 30 days or any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause |
In-Hospital (1 - 3 Days)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David E Kandzari, MD, Piedmont Heart Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-802
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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