Coronary Artery Disease
Conditions
Brief summary
To evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA dilatation catheter when used as a pre-dilatation device in the stenotic portion of coronary arteries or bypass grafts.
Interventions
DEVICEEmerge™ 1.20 mm PTCA Dilatation Catheter
The Emerge 1.20 mm device is the next-generation Boston Scientific PTCA dilatation catheter. It is a sterile, single-use, intravascular medical device used to improve lumen diameter. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: 1. Subject is ≥ 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures. 3. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure. 4. Subjects must have a single or double vessel coronary artery disease and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia. Angiographic Inclusion Criteria: 1. Subject must have de novo or restenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention. An embolic protection device must be used in all Saphenous venous grafts (SVG) interventions performed during the index procedure. 2. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries. 3. Target and non-target lesions must be located in different coronary arteries or bypass grafts. 4. Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may include chronic total occlusions (CTO) 5. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success.
Exclusion criteria
1. Subject with a known hypersensitivity or contraindication to Aspirin, Heparin, Bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated. 2. Subject with known diagnosis of an acute myocardial infarction (AMI) within 72 hours prior to index procedure. 3. Subject with known pregnancy or is nursing. Women of childbearing potential should have a documented negative pregnancy test within 7 days before index procedure. 4. Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure. 5. A serum creatinine level \> 2.0 mg/dl within seven days prior to index procedure. 6. Cerebrovascular accident (CVA) within the past 6 months. 7. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months. 8. Subject has a known left ventricular ejection fraction (LVEF) \<30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary). Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Procedural Success | Peri-procedural | Device procedural success consisting of the following: 1. Successful delivery, inflation, deflation and withdrawal of the study balloon. 2. No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon. 3. Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital Major Adverse Cardiac Events (MACE) | Participants will be followed for the duration of hospital stay (an expected average of 24 hours) | In-hospital MACE: 1. All death (cardiac and non-cardiac) 2. Myocardial infarction (MI) 3. Target Vessel Revascularization (TVR) 4. In-hospital Stent Thrombosis (ST) within the target vessel 5. Clinically significant arrhythmias (requiring intervention) |
Countries
United States
Participant flow
Recruitment details
Recruitment of subjects for EMERGE study started on July 09, 2012 and completed on December 14, 2012. Subjects were recruited at 3 investigational centers.
Participants by arm
| Arm | Count |
|---|---|
| Emerge Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Emerge |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Age Continuous | 60.9 years STANDARD_DEVIATION 10.5 |
| Cardiac History Congestive Heart Failure | 2 Participants |
| Cardiac History Previous Coronary Artery Bypass Graft | 11 Participants |
| Cardiac History Previous Myocardial Infarction | 14 Participants |
| Cardiac History Previous Percutaneous Coronary Intervention | 37 Participants |
| Cardiac History Silent Ischemia | 7 Participants |
| Cardiac History Stable Angina | 24 Participants |
| Cardiac History Unstable Angina | 25 Participants |
| Cardiac Risk Factors Family History of Coronary Artery Disease | 37 Participants |
| Cardiac Risk Factors Hyperlipidemia Requiring Medication | 51 Participants |
| Cardiac Risk Factors Hypertension Requiring Medication | 56 Participants |
| Cardiac Risk Factors Medically Treated Diabetes | 21 Participants |
| Cardiac Risk Factors Smoking, Ever | 36 Participants |
| Lesion Characteristic: Lesion Length From 18 and less than 26 mm | 11 Lesions |
| Lesion Characteristic: Lesion Length Greater or equal to 26 mm | 5 Lesions |
| Lesion Characteristic: Lesion Length Less than 18 mm | 51 Lesions |
| Lesion Characteristic: Lesion Location Distal | 8 Lesions |
| Lesion Characteristic: Lesion Location Mid | 32 Lesions |
| Lesion Characteristic: Lesion Location Ostial | 11 Lesions |
| Lesion Characteristic: Lesion Location Proximal | 16 Lesions |
| Lesion Characteristic: Percent Diameter Stenosis | 73.0 Percent Diameter Stenosis STANDARD_DEVIATION 12.6 |
| Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 0 (no perfusion) | 5 Lesions |
| Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 1 (penetration with minimal perfusion) | 2 Lesions |
| Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 2 (partial perfusion) | 1 Lesions |
| Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 3 (complete perfusion) | 59 Lesions |
| Lesion Characteristics Aneurysm | 3 Lesions |
| Lesion Characteristics Calcification, Any | 30 Lesions |
| Lesion Characteristics Eccentric Lesion | 40 Lesions |
| Lesion Characteristics Intimal Flap | 0 Lesions |
| Lesion Characteristics Lesion Length | 15.5 Millimeters STANDARD_DEVIATION 14.7 |
| Lesion Characteristics Minimum Lumen Diameter | 0.7 Millimeters STANDARD_DEVIATION 0.4 |
| Lesion Characteristics Reference Vessel Diameter | 2.6 Millimeters STANDARD_DEVIATION 0.5 |
| Lesion Characteristics Thrombus | 0 Lesions |
| Lesion Characteristics Tortuosity, Any | 9 Lesions |
| Lesion Characteristics Total Occlusion | 7 Lesions |
| Lesion Characteristics Ulcerated | 0 Lesions |
| Lesion Characteristic: Target Lesion Vessel Circumflex Artery | 14 Lesions |
| Lesion Characteristic: Target Lesion Vessel Graft | 2 Lesions |
| Lesion Characteristic: Target Lesion Vessel Left Anterior Descending Artery | 26 Lesions |
| Lesion Characteristic: Target Lesion Vessel Left Main Coronary Artery | 1 Lesions |
| Lesion Characteristic: Target Lesion Vessel Right Coronary Artery | 21 Lesions |
| Race/Ethnicity, Customized American Indian or Alaska native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black, or African American | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized White | 57 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 60 |
| serious Total, serious adverse events | 2 / 60 |
Outcome results
Primary
Device Procedural Success
Device procedural success consisting of the following: 1. Successful delivery, inflation, deflation and withdrawal of the study balloon. 2. No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon. 3. Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention procedure
Time frame: Peri-procedural
Population: Analysis population consists of intent-to-treat subject population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Emerge | Device Procedural Success | 98.3 percentage of participants |
Secondary
In-hospital Major Adverse Cardiac Events (MACE)
In-hospital MACE: 1. All death (cardiac and non-cardiac) 2. Myocardial infarction (MI) 3. Target Vessel Revascularization (TVR) 4. In-hospital Stent Thrombosis (ST) within the target vessel 5. Clinically significant arrhythmias (requiring intervention)
Time frame: Participants will be followed for the duration of hospital stay (an expected average of 24 hours)
Population: Analysis population consists of intent-to-treat subject population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Emerge | In-hospital Major Adverse Cardiac Events (MACE) | 6.7 percentage of participants |