Trial Outcomes & Findings for Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter (NCT NCT01635881)
NCT ID: NCT01635881
Last Updated: 2013-11-06
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
Peri-procedural
Results posted on
2013-11-06
Participant Flow
Recruitment of subjects for EMERGE study started on July 09, 2012 and completed on December 14, 2012. Subjects were recruited at 3 investigational centers.
Participant milestones
| Measure |
Emerge
Single arm with investigational Emerge™ 1.20 mm percutaneous transluminal coronary angioplasty (PTCA) Dilatation Catheter
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter
Baseline characteristics by cohort
| Measure |
Emerge
n=60 Participants
Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Age Continuous
|
60.9 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
|
Cardiac History
Previous Percutaneous Coronary Intervention
|
37 Participants
n=5 Participants
|
|
Cardiac History
Previous Coronary Artery Bypass Graft
|
11 Participants
n=5 Participants
|
|
Cardiac History
Previous Myocardial Infarction
|
14 Participants
n=5 Participants
|
|
Cardiac History
Congestive Heart Failure
|
2 Participants
n=5 Participants
|
|
Cardiac History
Stable Angina
|
24 Participants
n=5 Participants
|
|
Cardiac History
Unstable Angina
|
25 Participants
n=5 Participants
|
|
Cardiac History
Silent Ischemia
|
7 Participants
n=5 Participants
|
|
Cardiac Risk Factors
Smoking, Ever
|
36 Participants
n=5 Participants
|
|
Cardiac Risk Factors
Medically Treated Diabetes
|
21 Participants
n=5 Participants
|
|
Cardiac Risk Factors
Hyperlipidemia Requiring Medication
|
51 Participants
n=5 Participants
|
|
Cardiac Risk Factors
Hypertension Requiring Medication
|
56 Participants
n=5 Participants
|
|
Cardiac Risk Factors
Family History of Coronary Artery Disease
|
37 Participants
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Left Anterior Descending Artery
|
26 Lesions
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Circumflex Artery
|
14 Lesions
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Right Coronary Artery
|
21 Lesions
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Left Main Coronary Artery
|
1 Lesions
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Graft
|
2 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Ostial
|
11 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Proximal
|
16 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Mid
|
32 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Distal
|
8 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Length
Less than 18 mm
|
51 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Length
From 18 and less than 26 mm
|
11 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Length
Greater or equal to 26 mm
|
5 Lesions
n=5 Participants
|
|
Lesion Characteristics
Thrombus
|
0 Lesions
n=5 Participants
|
|
Lesion Characteristics
Tortuosity, Any
|
9 Lesions
n=5 Participants
|
|
Lesion Characteristics
Calcification, Any
|
30 Lesions
n=5 Participants
|
|
Lesion Characteristics
Ulcerated
|
0 Lesions
n=5 Participants
|
|
Lesion Characteristics
Aneurysm
|
3 Lesions
n=5 Participants
|
|
Lesion Characteristics
Intimal Flap
|
0 Lesions
n=5 Participants
|
|
Lesion Characteristics
Total Occlusion
|
7 Lesions
n=5 Participants
|
|
Lesion Characteristics
Eccentric Lesion
|
40 Lesions
n=5 Participants
|
|
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
0 (no perfusion)
|
5 Lesions
n=5 Participants
|
|
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
1 (penetration with minimal perfusion)
|
2 Lesions
n=5 Participants
|
|
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
2 (partial perfusion)
|
1 Lesions
n=5 Participants
|
|
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
3 (complete perfusion)
|
59 Lesions
n=5 Participants
|
|
Lesion Characteristics
Reference Vessel Diameter
|
2.6 Millimeters
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Lesion Characteristics
Minimum Lumen Diameter
|
0.7 Millimeters
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Lesion Characteristics
Lesion Length
|
15.5 Millimeters
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Lesion Characteristic: Percent Diameter Stenosis
|
73.0 Percent Diameter Stenosis
STANDARD_DEVIATION 12.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Peri-proceduralPopulation: Analysis population consists of intent-to-treat subject population.
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
Outcome measures
| Measure |
Emerge
n=60 Participants
Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
|
|---|---|
|
Device Procedural Success
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
SECONDARY outcome
Timeframe: 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.
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)
Outcome measures
| Measure |
Emerge
n=60 Participants
Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
|
|---|---|
|
In-hospital Major Adverse Cardiac Events (MACE)
|
6.7 percentage of participants
Interval 1.8 to 16.2
|
Adverse Events
Emerge
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Emerge
n=60 participants at risk
Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/60 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at hospital discharge.
|
|
Gastrointestinal disorders
Haematochrezia
|
1.7%
1/60 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at hospital discharge.
|
|
Gastrointestinal disorders
Melaena
|
3.3%
2/60 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at hospital discharge.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.7%
1/60 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at hospital discharge.
|
Other adverse events
| Measure |
Emerge
n=60 participants at risk
Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
5.0%
3/60 • Number of events 3 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at hospital discharge.
|
|
Investigations
Blood creatinine abnormal
|
1.7%
1/60 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at hospital discharge.
|
|
Investigations
Cardiac enzymes increased
|
1.7%
1/60 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at hospital discharge.
|
|
Investigations
Urine analysis abnormal
|
1.7%
1/60 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at hospital discharge.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.7%
1/60 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at hospital discharge.
|
|
Nervous system disorders
Paraesthesia
|
1.7%
1/60 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at hospital discharge.
|
|
Nervous system disorders
Syncope
|
1.7%
1/60 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at hospital discharge.
|
Additional Information
Andrey Nersesov, Clinical Trial Manager
Boston Scientific
Phone: 1-508-683-4988
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and Investigator shall have the right to publish the results, provided that before publishing, Institution and Investigator shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER