Trial Outcomes & Findings for Sapphire II PRO US Clinical Study (NCT NCT03052530)
NCT ID: NCT03052530
Last Updated: 2018-05-11
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 TIMI flow from baseline related to the study balloon * Final TIMI flow grade of 3 at the conclusion of the PCI procedure
COMPLETED
NA
61 participants
Peri-procedural (at Day 0)
2018-05-11
Participant Flow
Participant milestones
| Measure |
Sapphire II PRO
Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
Sapphire II PRO: To pre-dilate coronary arteries or bypass grafts during the subject's index procedure with Sapphire II PRO 1.0 and 1.25 PTCA dilatation catheters.
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sapphire II PRO US Clinical Study
Baseline characteristics by cohort
| Measure |
Sapphire II PRO
n=61 Participants
Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
|
|---|---|
|
Age, Continuous
|
67.26 Years
STANDARD_DEVIATION 9.35 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
61 Participants
n=99 Participants
|
|
Cardiac History
Previous Percutaneous Coronary Intervention
|
31 Participants
n=99 Participants
|
|
Cardiac History
Previous Coronary Artery Bypass Graft
|
18 Participants
n=99 Participants
|
|
Cardiac History
Previous Myocardial Infarction
|
25 Participants
n=99 Participants
|
|
Cardiac History
Stable Angina
|
31 Participants
n=99 Participants
|
|
Cardiac History
Unstable Angina
|
21 Participants
n=99 Participants
|
|
Cardiac Risk Factors
Current Cigarette Smoking (within 30 days)
|
10 Participants
n=99 Participants
|
|
Cardiac Risk Factors
Medically Treated Diabetes
|
16 Participants
n=99 Participants
|
|
Cardiac Risk Factors
Hypercholesterolemia Requiring Treatment
|
55 Participants
n=99 Participants
|
|
Cardiac Risk Factors
Hypertension Requiring Treatment
|
51 Participants
n=99 Participants
|
|
Lesion Characteristics: Vessel Treated
Bypass Graft
|
4 Lesions
n=99 Participants
|
|
Lesion Characteristics: Vessel Treated
Diagonol Branch-Left Anterior Descending Artery
|
10 Lesions
n=99 Participants
|
|
Lesion Characteristics: Vessel Treated
Left Anterior Descending Artery
|
22 Lesions
n=99 Participants
|
|
Lesion Characteristics: Vessel Treated
Left Circumflex Artery
|
12 Lesions
n=99 Participants
|
|
Lesion Characteristics: Vessel Treated
Marginal Branch of Left Circumflex Artery
|
1 Lesions
n=99 Participants
|
|
Lesion Characteristics: Vessel Treated
Posterior Descending Branch-Right Coronary Artery
|
2 Lesions
n=99 Participants
|
|
Lesion Characteristics: Vessel Treated
Right Coronary Artery
|
16 Lesions
n=99 Participants
|
|
Lesion Characteristics: Lesion Location
Distal
|
11 Lesions
n=99 Participants
|
|
Lesion Characteristics: Lesion Location
Mid
|
27 Lesions
n=99 Participants
|
|
Lesion Characteristics: Lesion Location
Ostial
|
3 Lesions
n=99 Participants
|
|
Lesion Characteristics: Lesion Location
Prox
|
26 Lesions
n=99 Participants
|
|
Lesion Characteristics
Lesion Length
|
18.42 Millimeters
STANDARD_DEVIATION 12.25 • n=99 Participants
|
|
Lesion Characteristics
Minimum Lumen Diameter
|
.52 Millimeters
STANDARD_DEVIATION .35 • n=99 Participants
|
|
Lesion Characteristics
Thrombus
|
1 Lesions
n=99 Participants
|
|
Lesion Characteristics
Tortuosity
|
0 Lesions
n=99 Participants
|
|
Lesion Characteristics
Calcification
|
34 Lesions
n=99 Participants
|
|
Lesion Characteristics
Ulceration
|
4 Lesions
n=99 Participants
|
|
Lesion Characteristics
Aneurysm
|
0 Lesions
n=99 Participants
|
|
Lesion Characteristics
Total Occlusion
|
9 Lesions
n=99 Participants
|
|
Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
0 (no perfusion)
|
9 Lesions
n=99 Participants
|
|
Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
1 (penetration with minimal perfusion)
|
4 Lesions
n=99 Participants
|
|
Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
2 (partial perfusion)
|
4 Lesions
n=99 Participants
|
|
Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
3 (complete perfusion)
|
50 Lesions
n=99 Participants
|
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 TIMI flow from baseline related to the study balloon * Final TIMI flow grade of 3 at the conclusion of the PCI procedure
Outcome measures
| Measure |
Sapphire II PRO
n=61 Participants
Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
|
|---|---|
|
Number of Participants With Device Procedural Success
|
59 Participants
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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) * All death (cardiac and non-cardiac) * Myocardial infarction (MI) * Target Lesion Revascularization (TLR)
Outcome measures
| Measure |
Sapphire II PRO
n=61 Participants
Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
|
|---|---|
|
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
|
1 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 |
Sapphire II PRO
n=61 Participants
Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation 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 |
Sapphire II PRO
n=61 Participants
Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
|
|---|---|
|
Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)
|
0 Participants
|
Adverse Events
Sapphire II PRO
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sapphire II PRO
n=61 participants at risk
Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/61 • Number of events 1 • Per the protocol, 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).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place