Trial Outcomes & Findings for Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial (NCT NCT04632641)
NCT ID: NCT04632641
Last Updated: 2024-10-03
Results Overview
The elapsed time between "device" removal and first observed and confirmed venous hemostasis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
107 participants
Primary outcome timeframe
Day 1
Results posted on
2024-10-03
Participant Flow
Participant milestones
| Measure |
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.
|
Figure 8 Suture - LARGE-BORE PROCEDURES
Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.
Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
54
|
|
Overall Study
COMPLETED
|
47
|
53
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial
Baseline characteristics by cohort
| Measure |
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
n=47 Participants
Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.
|
Figure 8 Suture - LARGE-BORE PROCEDURES
n=53 Participants
Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.
Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.5 Years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
69.6 Years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
69.6 Years
STANDARD_DEVIATION 11.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Body Mass Index
|
31.8 Kg/m2
STANDARD_DEVIATION 7.1 • n=99 Participants
|
30.3 Kg/m2
STANDARD_DEVIATION 6.6 • n=107 Participants
|
31.0 Kg/m2
STANDARD_DEVIATION 6.9 • n=206 Participants
|
|
Diabetes Mellitus
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Hypertension
|
27 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Chronic kidney disease/hemodialysis
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
End stage liver disease
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Prior stroke or trans ischemic attack
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1The elapsed time between "device" removal and first observed and confirmed venous hemostasis
Outcome measures
| Measure |
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
n=47 Participants
Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.
|
Figure 8 Suture - LARGE-BORE PROCEDURES
n=53 Participants
Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.
Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
|
|---|---|---|
|
Time to Achieve Hemostasis
|
7 Minutes
Interval 2.0 to 10.0
|
11 Minutes
Interval 10.0 to 15.0
|
PRIMARY outcome
Timeframe: Day 1The elapsed time between removal of the final Perclose ProGlide SMC device (treatment arm) or removal of the final sheath (control arm), and the ability of subjects to stand and ambulate 20 feet without evidence of venous re-bleeding from the femoral access sites.
Outcome measures
| Measure |
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
n=46 Participants
Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.
|
Figure 8 Suture - LARGE-BORE PROCEDURES
n=52 Participants
Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.
Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
|
|---|---|---|
|
Time to Ambulate
|
322 Minutes
Interval 246.0 to 452.0
|
403 Minutes
Interval 353.0 to 633.0
|
SECONDARY outcome
Timeframe: up to 5 days post procedureThe elapsed time between removal of the final sheath, and the ability of subjects to be discharged. Total length of hospital stay.
Outcome measures
| Measure |
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
n=47 Participants
Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.
|
Figure 8 Suture - LARGE-BORE PROCEDURES
n=53 Participants
Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.
Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
|
|---|---|---|
|
Time to Discharge (TTD)/Length of Stay (LOS)
|
1257 Minutes
Interval 1081.0 to 1544.0
|
1338 Minutes
Interval 1171.0 to 1435.0
|
SECONDARY outcome
Timeframe: up to 30 days post procedureBleeding associated with ≥2 g/dl drop in hemoglobin level requiring transfusion, bleeding that occurs at a critical site, or bleeding contributing to death.
Outcome measures
| Measure |
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
n=47 Participants
Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.
|
Figure 8 Suture - LARGE-BORE PROCEDURES
n=53 Participants
Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.
Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
|
|---|---|---|
|
Post Procedure Major Bleeding
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 30 days post procedureAny bleeding that does not meet the criteria for major bleeding
Outcome measures
| Measure |
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
n=47 Participants
Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.
|
Figure 8 Suture - LARGE-BORE PROCEDURES
n=53 Participants
Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.
Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
|
|---|---|---|
|
Minor Bleeding
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: up to 30 days post procedureAccess site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV (arteriovenous) fistula
Outcome measures
| Measure |
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
n=47 Participants
Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.
|
Figure 8 Suture - LARGE-BORE PROCEDURES
n=53 Participants
Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.
Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
|
|---|---|---|
|
Access Site Complications
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 30 days post procedureMortality due to vascular complications
Outcome measures
| Measure |
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
n=47 Participants
Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.
|
Figure 8 Suture - LARGE-BORE PROCEDURES
n=53 Participants
Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.
Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
|
|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
Adverse Events
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Figure 8 Suture - LARGE-BORE PROCEDURES
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
n=47 participants at risk
Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.
|
Figure 8 Suture - LARGE-BORE PROCEDURES
n=53 participants at risk
Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.
Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
|
|---|---|---|
|
Gastrointestinal disorders
GI bleed
|
6.4%
3/47 • Within 30 days of procedure date
|
0.00%
0/53 • Within 30 days of procedure date
|
|
Cardiac disorders
Severe mitral valve regurgitation
|
2.1%
1/47 • Within 30 days of procedure date
|
0.00%
0/53 • Within 30 days of procedure date
|
|
Vascular disorders
Stroke
|
2.1%
1/47 • Within 30 days of procedure date
|
1.9%
1/53 • Within 30 days of procedure date
|
|
Surgical and medical procedures
Bleeding and Hematoma
|
0.00%
0/47 • Within 30 days of procedure date
|
1.9%
1/53 • Within 30 days of procedure date
|
|
Blood and lymphatic system disorders
Acute anemia
|
0.00%
0/47 • Within 30 days of procedure date
|
1.9%
1/53 • Within 30 days of procedure date
|
|
Injury, poisoning and procedural complications
Oozing
|
0.00%
0/47 • Within 30 days of procedure date
|
1.9%
1/53 • Within 30 days of procedure date
|
|
Injury, poisoning and procedural complications
Bleeding
|
0.00%
0/47 • Within 30 days of procedure date
|
1.9%
1/53 • Within 30 days of procedure date
|
Other adverse events
| Measure |
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
n=47 participants at risk
Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.
|
Figure 8 Suture - LARGE-BORE PROCEDURES
n=53 participants at risk
Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.
Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hematoma
|
0.00%
0/47 • Within 30 days of procedure date
|
3.8%
2/53 • Within 30 days of procedure date
|
|
Injury, poisoning and procedural complications
Bilateral groin bruising/ecchymosis
|
0.00%
0/47 • Within 30 days of procedure date
|
1.9%
1/53 • Within 30 days of procedure date
|
|
Injury, poisoning and procedural complications
Oozing
|
4.3%
2/47 • Within 30 days of procedure date
|
0.00%
0/53 • Within 30 days of procedure date
|
|
Injury, poisoning and procedural complications
Bleeding
|
4.3%
2/47 • Within 30 days of procedure date
|
1.9%
1/53 • Within 30 days of procedure date
|
|
Renal and urinary disorders
Hematuria
|
4.3%
2/47 • Within 30 days of procedure date
|
0.00%
0/53 • Within 30 days of procedure date
|
|
Injury, poisoning and procedural complications
Wrist/forearm pain/swelling and bruising
|
0.00%
0/47 • Within 30 days of procedure date
|
1.9%
1/53 • Within 30 days of procedure date
|
|
Cardiac disorders
Atypical chest pain
|
2.1%
1/47 • Within 30 days of procedure date
|
0.00%
0/53 • Within 30 days of procedure date
|
|
Infections and infestations
Chest pain
|
2.1%
1/47 • Within 30 days of procedure date
|
0.00%
0/53 • Within 30 days of procedure date
|
|
General disorders
Severe headache and hypertension
|
2.1%
1/47 • Within 30 days of procedure date
|
0.00%
0/53 • Within 30 days of procedure date
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place