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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Device | Enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Procedure Success | Procedure success was defined as meeting all the following after single or multiple attempts:
| On Day 0 (From the start to end of the interventional procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Device Success | Device Success was defined as meeting all the following after single or multiple attempts:
|
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Inclusion Criteria:
General Inclusion Criteria
Angiographic Inclusion Criteria
All angiographic inclusion criteria are based on visual estimation.
Exclusion Criteria:
General Exclusion Criteria
Angiographic Exclusion Criteria
All angiographic exclusion criteria are based on visual estimation.
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Subjects will be enrolled at 4 sites in the United States (US). At each site, at least two different qualified physicians will perform the index procedures. Approximately 30% of the enrolled subjects will be females.
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| Name | Affiliation | Role |
|---|---|---|
| David E Kandzari, MD | Piedmont Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Green Hospital | La Jolla | California | 92037 | United States | ||
| Peninsula Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23369084 | Derived | Kandzari DE, Teirstein PS, Kereiakes DJ, Cannon LA, Hearne SE, Kuo HC, Ying SW, Cheong WF, Popma JJ. Procedural effectiveness of a novel 1.20 mm diameter angioplasty catheter: clinical and angiographic outcomes. J Interv Cardiol. 2013 Apr;26(2):131-6. doi: 10.1111/j.1540-8183.2013.12021.x. Epub 2013 Jan 31. |
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A total of 71 subjects were enrolled at 4 clinical sites in the US between August 12, 2010 and December 30, 2010. All subjects were followed in-hospital up to discharge.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. MINI TREK RX 1.20 mm Coronary Dilatation Catheter: Enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| On Day 0 (From the start to end of the interventional procedure) |
| Rate of Lesion Success | Lesion Success was defined as meeting all the following after single or multiple attempts:
| On Day 0 (From the start to end of the interventional procedure) |
| Rate of Individual Procedural Parameters | The following parameters were assessed by either an angiographic core laboratory or the investigator at the site
| On Day 0 (From the start to end of the interventional procedure) |
| Rate of Major Adverse Cardiac Event (MACE) | 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 | In-Hospital (1 - 3 Days) |
| Rate of Target Lesion Failure (TLF) | 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 | In-Hospital (1 - 3 Days) |
| Rate of Stent Thrombosis | 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) |
| Salisbury |
| Maryland |
| 21804 |
| United States |
| Northern Michigan Hospital | Petoskey | Michigan | 49770 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| COMPLETED |
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| NOT COMPLETED |
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71 patients were enrolled; however, subjects can be counted in more than one race category therefore the total in the table by race is greater than 71 patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. MINI TREK RX 1.20 mm Coronary Dilatation Catheter: Enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Prior coronary intervention | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Procedure Success | Procedure success was defined as meeting all the following after single or multiple attempts:
| The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | percentage of participants | On Day 0 (From the start to end of the interventional procedure) |
|
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| Secondary | Rate of Device Success | Device Success was defined as meeting all the following after single or multiple attempts:
| The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | Percentage of target lesions | On Day 0 (From the start to end of the interventional procedure) | Target lesions | Target lesions |
|
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| Secondary | Rate of Lesion Success | Lesion Success was defined as meeting all the following after single or multiple attempts:
| The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | 95% Confidence Interval | Percentage of target lesions | On Day 0 (From the start to end of the interventional procedure) | Target lesions | Target lesions |
|
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| Secondary | Rate of Individual Procedural Parameters | The following parameters were assessed by either an angiographic core laboratory or the investigator at the site
| The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | percentage of participants | On Day 0 (From the start to end of the interventional procedure) | Target lesions | Target lesions |
|
| |||||||||||||||||||||||||
| Secondary | Rate of Major Adverse Cardiac Event (MACE) | 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 | The number of participants analyzed includes subjects who were available at that timeof analysis | Posted | Count of Participants | Participants | In-Hospital (1 - 3 Days) |
|
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| Secondary | Rate of Target Lesion Failure (TLF) | 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 | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | In-Hospital (1 - 3 Days) |
|
| |||||||||||||||||||||||||||
| Secondary | Rate of Stent Thrombosis | 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 | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | percentage of participants | In-Hospital (1 - 3 Days) |
|
In-hospital Assessment Only
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. MINI TREK RX 1.20 mm Coronary Dilatation Catheter: Enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions | 0 | 71 | 6 | 71 | 0 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Periprocedural Non-Q-wave Myocardial Infarction (NQMI) | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Coe | Abbott Medical Devices | 224 668 5360 | Jessie.coe@abbott.com |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
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| Asian |
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| Black or African Heritage |
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| Native Hawaiian or Pacific Islanders |
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| White |
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| Participants |
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| Target lesions |
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| Target lesions |
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| Target lesions |
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| Units | Counts |
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| Participants |
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