Trial Outcomes & Findings for Cook Enforcer Post-Market Study (NCT NCT03552289)
NCT ID: NCT03552289
Last Updated: 2020-10-19
Results Overview
Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
211 participants
Primary outcome timeframe
Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour
Results posted on
2020-10-19
Participant Flow
Unit of analysis: Lesions
Participant milestones
| Measure |
Cook Enforcer Balloon Catheter
The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter: The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
|
Conventional Angioplasty Balloon Catheters
Commercial available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Conventional angioplasty balloon catheters: Commercial available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
|
|---|---|---|
|
Overall Study
STARTED
|
102 120
|
109 130
|
|
Overall Study
COMPLETED
|
101 119
|
106 125
|
|
Overall Study
NOT COMPLETED
|
1 1
|
3 5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cook Enforcer Post-Market Study
Baseline characteristics by cohort
| Measure |
Cook Enforcer Balloon Catheter
n=102 Participants
The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter: The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
|
Conventional Angioplasty Balloon Catheters
n=109 Participants
Commercial available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Conventional angioplasty balloon catheters: Commercial available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
65.5 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
97 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hourPercentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon
Outcome measures
| Measure |
Cook Enforcer Balloon Catheter
n=120 Lesions
The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter: The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
|
Conventional Angioplasty Balloon Catheters
n=130 Lesions
Commercial available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Conventional angioplasty balloon catheters: Commercial available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
|
|---|---|---|
|
Percent of Lesions Requiring Adjunctive Treatment
|
30 Lesions
|
26 Lesions
|
Adverse Events
Cook Enforcer Balloon Catheter
Serious events: 2 serious events
Other events: 24 other events
Deaths: 1 deaths
Conventional Angioplasty Balloon Catheters
Serious events: 1 serious events
Other events: 23 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cook Enforcer Balloon Catheter
n=102 participants at risk
The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter: The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
|
Conventional Angioplasty Balloon Catheters
n=109 participants at risk
Commercial available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Conventional angioplasty balloon catheters: Commercial available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
|
|---|---|---|
|
Injury, poisoning and procedural complications
Right Femur Fracture after fall
|
0.98%
1/102 • Number of events 1 • 90 days
|
0.00%
0/109 • 90 days
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer of lower extremity
|
0.98%
1/102 • Number of events 1 • 90 days
|
0.00%
0/109 • 90 days
|
|
Injury, poisoning and procedural complications
Head injury s/p fall
|
0.98%
1/102 • Number of events 1 • 90 days
|
0.00%
0/109 • 90 days
|
|
Infections and infestations
Septic Shock
|
0.00%
0/102 • 90 days
|
0.92%
1/109 • Number of events 1 • 90 days
|
Other adverse events
| Measure |
Cook Enforcer Balloon Catheter
n=102 participants at risk
The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter: The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
|
Conventional Angioplasty Balloon Catheters
n=109 participants at risk
Commercial available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Conventional angioplasty balloon catheters: Commercial available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
|
|---|---|---|
|
Vascular disorders
Restenosis or occlusion
|
23.5%
24/102 • Number of events 26 • 90 days
|
17.4%
19/109 • Number of events 23 • 90 days
|
|
Vascular disorders
Thrombosis
|
2.0%
2/102 • Number of events 3 • 90 days
|
5.5%
6/109 • Number of events 8 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place