Trial Outcomes & Findings for Scoreflex NC - Scoring PTCA Catheter (NCT NCT03763747)
NCT ID: NCT03763747
Last Updated: 2021-08-11
Results Overview
Device procedural success consisting of the following: * Successful delivery, inflation, deflation, and withdrawal of the study balloon * No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the Scoreflex NC study balloon * Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Peri-procedural (at Day 0)
Results posted on
2021-08-11
Participant Flow
Participant milestones
| Measure |
Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
200
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Scoreflex NC - Scoring PTCA Catheter
Baseline characteristics by cohort
| Measure |
Scoreflex NC Scoring PTCA Catheter
n=221 Lesions
Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
|
|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
154 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
178 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian/Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian/Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
200 Participants
n=5 Participants
|
|
Cardiac History
Prior Percutaneous Coronary Intervention
|
106 Participants
n=5 Participants
|
|
Cardiac History
Prior Coronary Artery Bypass Graft
|
26 Participants
n=5 Participants
|
|
Cardiac History
Prior Myocardial Infarction
|
61 Participants
n=5 Participants
|
|
Current Cardiac Status
Asymptomatic
|
18 Participants
n=5 Participants
|
|
Current Cardiac Status
Silent Ischemia
|
8 Participants
n=5 Participants
|
|
Current Cardiac Status
Stable Angina
|
116 Participants
n=5 Participants
|
|
Current Cardiac Status
Unstable Angina
|
57 Participants
n=5 Participants
|
|
Current Cardiac Status
ST-Elevation Myocardial Infarction (STEMI)
|
1 Participants
n=5 Participants
|
|
Cardiac Risk Factors
Cigarette Smoking (within 30 days)
|
37 Participants
n=5 Participants
|
|
Cardiac Risk Factors
Diabetes Mellitus
|
88 Participants
n=5 Participants
|
|
Cardiac Risk Factors
Diabetes Mellitus (Insulin requiring)
|
20 Participants
n=5 Participants
|
|
Cardiac Risk Factors
Hypercholesterolemia Requiring Treatment
|
181 Participants
n=5 Participants
|
|
Cardiac Risk Factors
Hypertension Requiring Treatment
|
182 Participants
n=5 Participants
|
|
Angiographic Characteristics: Vessel Location (Core Lab assessed)
Left Anterior Descending Artery (LAD)
|
97 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Vessel Location (Core Lab assessed)
Left Circumflex Artery (LCX)
|
55 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Vessel Location (Core Lab assessed)
Right Coronary Artery (RCA)
|
68 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Vessel Location (Core Lab assessed)
Not Identified
|
1 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Lesion Location (Core Lab assessed)
Ostial
|
7 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Lesion Location (Core Lab assessed)
Proximal
|
98 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Lesion Location (Core Lab assessed)
Middle
|
93 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Lesion Location (Core Lab assessed)
Distal
|
23 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Lesion Characteristics (Core Lab assessed)
Lesion Length
|
18.37 Millimeters
STANDARD_DEVIATION 12.93 • n=30 Lesions
|
|
Angiographic Characteristics: Lesion Characteristics (Core Lab assessed)
Minimal Luminal Diameter
|
0.8 Millimeters
STANDARD_DEVIATION 0.40 • n=30 Lesions
|
|
Angiographic Characteristics: Lesion Characteristics (Core Lab assessed)
Moderate/Severe Calcification
|
81 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Lesion Characteristics (Core Lab assessed)
Moderate/Severe Tortuosity
|
7 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Lesion Characteristics (Core Lab assessed)
Total Occlusion
|
11 Lesions
n=30 Lesions
|
|
Baseline Thrombolysis in Myocardial Infarction (TIMI) Flow (Core Lab assessed)
0 (no perfusion)
|
6 Lesions
n=30 Lesions
|
|
Baseline Thrombolysis in Myocardial Infarction (TIMI) Flow (Core Lab assessed)
1 (penetration with minimal perfusion)
|
5 Lesions
n=30 Lesions
|
|
Baseline Thrombolysis in Myocardial Infarction (TIMI) Flow (Core Lab assessed)
2 (partial perfusion)
|
6 Lesions
n=30 Lesions
|
|
Baseline Thrombolysis in Myocardial Infarction (TIMI) Flow (Core Lab assessed)
3 (complete perfusion)
|
204 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed)
0,0,0
|
2 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed)
0,0,1
|
3 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed)
0,1,0
|
38 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed)
1,0,0
|
16 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed)
0,1,1
|
8 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed)
1,0,1
|
3 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed)
1,1,0
|
8 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed)
1,1,1
|
6 Lesions
n=30 Lesions
|
|
Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed)
Non-bifurcation lesions
|
137 Lesions
n=30 Lesions
|
PRIMARY outcome
Timeframe: Peri-procedural (at Day 0)Population: Analysis population consists of intent-to-treat subject population.
Device procedural success consisting of the following: * Successful delivery, inflation, deflation, and withdrawal of the study balloon * No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the Scoreflex NC study balloon * Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure
Outcome measures
| Measure |
Scoreflex NC Scoring PTCA Catheter
n=200 Participants
Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
|
|---|---|
|
Number of Participants With Device Procedural Success
|
187 Participants
|
SECONDARY outcome
Timeframe: Peri-procedural (at Day 0)Population: Analysis population consists of intent-to-treat subject population.
Angiographic Procedural Success defined as Final diameter stenosis ≤ 50% in at least one of the Scoreflex NC attempted lesions following completion of the interventional procedure, including adjunctive stenting
Outcome measures
| Measure |
Scoreflex NC Scoring PTCA Catheter
n=200 Participants
Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
|
|---|---|
|
Number of Participants With Angiographic Procedural Success
|
197 Participants
|
SECONDARY outcome
Timeframe: Endpoints will be measured through hospital discharge (expected to be within 24 hours)Population: Analysis population consists of intent-to-treat subject population.
In-hospital Major Adverse Cardiac Events (MACE), a composite of: * All death (cardiac and non-cardiac) * Myocardial infarction (MI) * Target Lesion Revascularization (TLR), clinically indicated
Outcome measures
| Measure |
Scoreflex NC Scoring PTCA Catheter
n=200 Participants
Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
|
|---|---|
|
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
|
9 Participants
|
SECONDARY outcome
Timeframe: Endpoint will be measured through hospital discharge (expected to be within 24 hours)Population: Analysis population consists of intent-to-treat subject population.
In-hospital stent thrombosis (ST) within the Target Vessel
Outcome measures
| Measure |
Scoreflex NC Scoring PTCA Catheter
n=200 Participants
Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
|
|---|---|
|
Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel
|
0 Participants
|
SECONDARY outcome
Timeframe: Endpoint will be measured through hospital discharge (expected to be within 24 hours)Population: Analysis population consists of intent-to-treat subject population.
Clinically Significant Arrhythmias (Requiring Intervention)
Outcome measures
| Measure |
Scoreflex NC Scoring PTCA Catheter
n=200 Participants
Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
|
|---|---|
|
Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)
|
1 Participants
|
SECONDARY outcome
Timeframe: Peri-proceduralPopulation: Analysis population consists of intent-to-treat subject population. Site reported data represented on the use of 239 Scoreflex NC Scoring PTCA catheter study devices.
Occurrence of Scoreflex NC Study Balloon rupture
Outcome measures
| Measure |
Scoreflex NC Scoring PTCA Catheter
n=239 Scoreflex NC Scoring PTCA catheters
Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
|
|---|---|
|
Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture
|
2 Scoreflex NC Scoring PTCA catheters
|
SECONDARY outcome
Timeframe: Peri-proceduralPopulation: Analysis population consists of intent-to-treat subject population. Please note that the data for Number of Participants that had Improvement in Minimum Lumen Diameter was not analyzable in 23 patients by the Angiographic Core Lab.
Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA). Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline.
Outcome measures
| Measure |
Scoreflex NC Scoring PTCA Catheter
n=177 Participants
Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
|
|---|---|
|
Number of Participants That Had Improvement in Minimum Lumen Diameter (MLD) Following Use of Scoreflex NC Catheter (Measured by Quantitative Coronary Angiography (QCA))
|
161 Participants
|
Adverse Events
Scoreflex NC Scoring PTCA Catheter
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Scoreflex NC Scoring PTCA Catheter
n=200 participants at risk
Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
|
|---|---|
|
Cardiac disorders
Target Lesion Revascularization Clinically Indicated TLR)
|
0.50%
1/200 • Number of events 1 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
|
|
Cardiac disorders
Myocardial Infarction (Non Q-wave)
|
0.50%
1/200 • Number of events 1 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
|
Other adverse events
| Measure |
Scoreflex NC Scoring PTCA Catheter
n=200 participants at risk
Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
|
|---|---|
|
Cardiac disorders
Myocardial Infarction (Non Q-wave)
|
3.5%
7/200 • Number of events 7 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
|
|
Cardiac disorders
Clinically Significant Arrhythmias (Requiring Intervention)
|
0.50%
1/200 • Number of events 1 • Adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
|
Additional Information
Stephen M. Rowland, PhD - Vice-President, Research and Development
OrbusNeich
Phone: 954-730-0711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place