Trial Outcomes & Findings for Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice) (NCT NCT01600482)
NCT ID: NCT01600482
Last Updated: 2017-08-23
Results Overview
rate of major complications with in 30 +/- 7 days following the PCI procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
241 participants
Primary outcome timeframe
With in the first 30 days +/- 7 days following the procedure
Results posted on
2017-08-23
Participant Flow
As per agreement with FDA, following the 207 patient 6F Celt ACD study, an additional 34 patients were recruited across 3 clinical investigation sites whereby a 7F Celt ACD device was used to close an arterial puncture made with a 7F sheath in fully anti-coagulated patients. 7F device approval is pending with FDA.
Participant milestones
| Measure |
CELT ACD Device
The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath.
|
Manual Compression
Manual Compression
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
59
|
|
Overall Study
COMPLETED
|
148
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CELT ACD Device
n=148 Participants
The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath.
|
Manual Compression
n=59 Participants
Manual Compression
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.75 Years
STANDARD_DEVIATION 10.8 • n=148 Participants
|
67.44 Years
STANDARD_DEVIATION 11.7 • n=59 Participants
|
66.95 Years
STANDARD_DEVIATION 11.00 • n=207 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=148 Participants
|
12 Participants
n=59 Participants
|
48 Participants
n=207 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=148 Participants
|
47 Participants
n=59 Participants
|
159 Participants
n=207 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
37 participants
n=148 Participants
|
20 participants
n=59 Participants
|
57 participants
n=207 Participants
|
|
Region of Enrollment
Ireland
|
69 participants
n=148 Participants
|
21 participants
n=59 Participants
|
90 participants
n=207 Participants
|
|
Region of Enrollment
Germany
|
42 participants
n=148 Participants
|
18 participants
n=59 Participants
|
60 participants
n=207 Participants
|
|
Weight
|
85.38 Kgs
STANDARD_DEVIATION 16.22 • n=148 Participants
|
82.78 Kgs
STANDARD_DEVIATION 40.83 • n=59 Participants
|
84.65 Kgs
STANDARD_DEVIATION 15.80 • n=207 Participants
|
|
Height
|
172.90 cm
STANDARD_DEVIATION 9.56 • n=148 Participants
|
171.70 cm
STANDARD_DEVIATION 7.82 • n=59 Participants
|
172.50 cm
STANDARD_DEVIATION 9.12 • n=207 Participants
|
|
BMI
|
27.75 kg/m^2
STANDARD_DEVIATION 4.47 • n=148 Participants
|
28.18 kg/m^2
STANDARD_DEVIATION 4.41 • n=59 Participants
|
27.87 kg/m^2
STANDARD_DEVIATION 4.45 • n=207 Participants
|
|
Right Femoral Artery Site
|
142 Participants
n=148 Participants
|
57 Participants
n=59 Participants
|
199 Participants
n=207 Participants
|
PRIMARY outcome
Timeframe: With in the first 30 days +/- 7 days following the procedurerate of major complications with in 30 +/- 7 days following the PCI procedure.
Outcome measures
| Measure |
CELT ACD Device
n=148 Participants
The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath.
|
Manual Compression
n=59 Participants
Manual Compression
|
|---|---|---|
|
The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure.
|
1 major complications
|
2 major complications
|
PRIMARY outcome
Timeframe: With in the first 30 days +/- 7 days following the procedurePopulation: 7 subjects in manual compression group where TTH was not recorded.
Time to hemostasis
Outcome measures
| Measure |
CELT ACD Device
n=148 Participants
The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath.
|
Manual Compression
n=52 Participants
Manual Compression
|
|---|---|---|
|
The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH)
|
0.99 minutes
Standard Deviation 4.15
|
17.54 minutes
Standard Deviation 54.55
|
SECONDARY outcome
Timeframe: With in the first 30 days +/- 7 days following the procedurecombined rate of minor complications with in 30 +/- 7 days following procedure.
Outcome measures
| Measure |
CELT ACD Device
n=148 Participants
The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath.
|
Manual Compression
n=59 Participants
Manual Compression
|
|---|---|---|
|
The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure.
|
7 minor complications
|
5 minor complications
|
SECONDARY outcome
Timeframe: With in the first 30 days +/- 7 days following the procedurePopulation: 62 patients did not have TTA recorded.
Time to Ambulation (TTA) is defined as the time elapsed between sheath removal and time when the patient stands and walk 6m (20ft) without re-bleeding.
Outcome measures
| Measure |
CELT ACD Device
n=101 Participants
The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath.
|
Manual Compression
n=44 Participants
Manual Compression
|
|---|---|---|
|
Time to Ambulation
|
360.0 minutes
Standard Deviation 418.4
|
406.4 minutes
Standard Deviation 216.2
|
SECONDARY outcome
Timeframe: 30 days +/- 7 daysPopulation: 107 did not have time to dischargeability data collected.
Time to discharge-ability
Outcome measures
| Measure |
CELT ACD Device
n=71 Participants
The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath.
|
Manual Compression
n=29 Participants
Manual Compression
|
|---|---|---|
|
Time to Discharge-ability
|
662.51 Minutes
Standard Deviation 511.70
|
511.76 Minutes
Standard Deviation 350.2
|
SECONDARY outcome
Timeframe: 30 days +/- 7 daysPopulation: 7 patients were excluded in Manual Compression group as there was no TTH data recorded.
Procedure Success 30 days +/- 7 days
Outcome measures
| Measure |
CELT ACD Device
n=148 Participants
The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath.
|
Manual Compression
n=52 Participants
Manual Compression
|
|---|---|---|
|
Procedure Success
|
147 Number of patients
|
51 Number of patients
|
SECONDARY outcome
Timeframe: 30 days +/- 7 daysPopulation: 7 patients in the MP group did not have TTH recorded.
Device Success (DS) is defined as the successful deployment of the Celt ACD device with the attainment of haemostasis and only assessed in the Celt ACD arm of the study.
Outcome measures
| Measure |
CELT ACD Device
n=148 Participants
The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath.
|
Manual Compression
Manual Compression
|
|---|---|---|
|
Device Success
|
147 Number of patients
|
—
|
Adverse Events
CELT ACD Device
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Manual Compression
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CELT ACD Device
n=148 participants at risk
The CELT ACD device is a vascular closure device.
CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath.
|
Manual Compression
n=59 participants at risk
Manual Compression
|
|---|---|---|
|
Surgical and medical procedures
Device migration
|
0.68%
1/148 • Number of events 1 • 30 days +/- 7 days
|
0.00%
0/59 • 30 days +/- 7 days
|
|
Surgical and medical procedures
Syncope
|
0.00%
0/148 • 30 days +/- 7 days
|
1.7%
1/59 • Number of events 1 • 30 days +/- 7 days
|
|
Vascular disorders
Brain Stem Ischemia
|
0.00%
0/148 • 30 days +/- 7 days
|
1.7%
1/59 • Number of events 1 • 30 days +/- 7 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place