Trial Outcomes & Findings for A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions (NCT NCT01186198)
NCT ID: NCT01186198
Last Updated: 2023-11-13
Results Overview
Procedure success was defined as meeting all the following after single or multiple attempts: 1. Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion, 2. Successful inflation and deflation with the MINI TREK RX 1.20 mm balloon, 3. No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon, and 4. Achieve a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the lesion.
COMPLETED
71 participants
On Day 0 (From the start to end of the interventional procedure)
2023-11-13
Participant Flow
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.
Participant milestones
| Measure |
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
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|---|---|
|
Overall Study
STARTED
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71
|
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Overall Study
COMPLETED
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71
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions
Baseline characteristics by cohort
| Measure |
MINI TREK RX 1.20 mm Coronary Dilatation Catheter
n=71 Participants
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
|
|---|---|
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Age, Continuous
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64.75 years
STANDARD_DEVIATION 10.95 • n=5 Participants
|
|
Sex: Female, Male
Female
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21 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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50 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
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0 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black or African Heritage
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Native Hawaiian or Pacific Islanders
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0 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
White
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68 Participants
n=5 Participants
|
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Region of Enrollment
United States
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71 Participants
n=5 Participants
|
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Prior coronary intervention
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52 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: On Day 0 (From the start to end of the interventional procedure)Population: The number of participants analyzed includes subjects who were available at that time of analysis
Procedure success was defined as meeting all the following after single or multiple attempts: 1. Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion, 2. Successful inflation and deflation with the MINI TREK RX 1.20 mm balloon, 3. No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon, and 4. Achieve a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the lesion.
Outcome measures
| Measure |
MINI TREK RX 1.20 mm Coronary Dilatation Catheter
n=67 Participants
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
|
|---|---|
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Percentage of Participants With Procedure Success
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98.5 percentage of participants
Interval 91.96 to 99.96
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SECONDARY outcome
Timeframe: On Day 0 (From the start to end of the interventional procedure)Population: The number of participants analyzed includes subjects who were available at that time of analysis
Device Success was defined as meeting all the following after single or multiple attempts: 1. Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion, defined as achieving a final residual percent diameter stenosis of \< 50%, 2. Successful dilatation with the MINI TREK RX 1.20 mm balloon as defined by improvement in Minimal Lumen Diameter (MLD) based on core lab analysis, and 3. No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias that required medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon.
Outcome measures
| Measure |
MINI TREK RX 1.20 mm Coronary Dilatation Catheter
n=78 Target lesions
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
|
|---|---|
|
Rate of Device Success
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96.2 Percentage of target lesions
Interval 89.17 to 99.2
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SECONDARY outcome
Timeframe: On Day 0 (From the start to end of the interventional procedure)Population: The number of participants analyzed includes subjects who were available at that time of analysis
Lesion Success was defined as meeting all the following after single or multiple attempts: 1. Successful dilatation with any device(s), defined as achieving a final residual percent diameter stenosis of \< 50%, 2. No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with any device(s), and 3. Achievement of a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the lesion.
Outcome measures
| Measure |
MINI TREK RX 1.20 mm Coronary Dilatation Catheter
n=83 Target lesions
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
|
|---|---|
|
Rate of Lesion Success
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97.6 Percentage of target lesions
Interval 91.57 to 99.71
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SECONDARY outcome
Timeframe: On Day 0 (From the start to end of the interventional procedure)Population: The number of participants analyzed includes subjects who were available at that time of analysis
The following parameters were assessed by either an angiographic core laboratory or the investigator at the site * Vessel perforation * Flow-limiting vessel dissection * Development of thrombus in the target vessel * Balloon rupture * Clinically significant arrhythmias requiring medical treatment or device intervention
Outcome measures
| Measure |
MINI TREK RX 1.20 mm Coronary Dilatation Catheter
n=83 Target lesions
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
|
|---|---|
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Rate of Individual Procedural Parameters
Vessel Perforation
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0.0 percentage of participants
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|
Rate of Individual Procedural Parameters
Flow-Limiting Vessel Dissection
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0.0 percentage of participants
|
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Rate of Individual Procedural Parameters
Development of Thrombus in the Target Vessel
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0.0 percentage of participants
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Rate of Individual Procedural Parameters
Balloon Rupture
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0.0 percentage of participants
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Rate of Individual Procedural Parameters
Clinically Significant Arrhythmias Requiring Medical Treatment or Device Intervention
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0.0 percentage of participants
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SECONDARY outcome
Timeframe: In-Hospital (1 - 3 Days)Population: The number of participants analyzed includes subjects who were available at that timeof analysis
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
Outcome measures
| Measure |
MINI TREK RX 1.20 mm Coronary Dilatation Catheter
n=71 Participants
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
|
|---|---|
|
Rate of Major Adverse Cardiac Event (MACE)
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6 Participants
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SECONDARY outcome
Timeframe: In-Hospital (1 - 3 Days)Population: The number of participants analyzed includes subjects who were available at that time of analysis
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
Outcome measures
| Measure |
MINI TREK RX 1.20 mm Coronary Dilatation Catheter
n=71 Participants
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
|
|---|---|
|
Rate of Target Lesion Failure (TLF)
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6 Participants
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SECONDARY outcome
Timeframe: In-Hospital (1 - 3 Days)Population: The number of participants analyzed includes subjects who were available at that time of analysis
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
Outcome measures
| Measure |
MINI TREK RX 1.20 mm Coronary Dilatation Catheter
n=64 Participants
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
|
|---|---|
|
Rate of Stent Thrombosis
Acute Stent Thrombosis
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0 percentage of participants
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Rate of Stent Thrombosis
Subacute Stent Thrombosis
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0 percentage of participants
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Rate of Stent Thrombosis
Acute/Subacute Stent Thrombosis
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0 percentage of participants
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Adverse Events
MINI TREK RX 1.20 mm Coronary Dilatation Catheter
Serious adverse events
| Measure |
MINI TREK RX 1.20 mm Coronary Dilatation Catheter
n=71 participants at risk
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
|
|---|---|
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Cardiac disorders
Periprocedural Non-Q-wave Myocardial Infarction (NQMI)
|
8.5%
6/71 • In-hospital Assessment Only
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60