Trial Outcomes & Findings for FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF) (NCT NCT05034939)
NCT ID: NCT05034939
Last Updated: 2025-07-03
Results Overview
Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 30 days post- procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
30 Days
Results posted on
2025-07-03
Participant Flow
Participant milestones
| Measure |
FLEX Vessel Prep System Followed With PTA (TEST Arm)
FLEX Vessel Prep System is used to create circumferential, continuous micro-incisions along the length of the stenosis by performing a retrograde pullback through the lesion. Following FLEX, standard balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care.
FLEX Vessel Prep System: The FLEX Vessel Prep System™ is an over-the-wire sheathed catheter with a three-strut treatment element near the distal tip. As the device is pulled back in a retrograde fashion through the target lesion, the Treatment Element "flexes" providing continuous engagement along the lesion to create controlled depth micro-incisions.
|
PTA Only (CONTROL Arm)
Standard Balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care.
Angioplasty: The brand and type of PTA balloon(s) used will be at the discretion of the treating physician and used according to its Instructions for Use (IFU). PTA balloons consist of an over-the-wire catheter with a balloon fixed at the distal tip. Within the lesion the balloon is inflated to a pressure that allows full effacement.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
37
|
|
Overall Study
COMPLETED
|
38
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)
Baseline characteristics by cohort
| Measure |
FLEX Vessel Prep System Followed With PTA (TEST Arm)
n=38 Participants
FLEX Vessel Prep System is used to create circumferential, continuous micro-incisions along the length of the stenosis by performing a retrograde pullback through the lesion. Following FLEX, standard balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care.
FLEX Vessel Prep System: The FLEX Vessel Prep System™ is an over-the-wire sheathed catheter with a three-strut treatment element near the distal tip. As the device is pulled back in a retrograde fashion through the target lesion, the Treatment Element "flexes" providing continuous engagement along the lesion to create controlled depth micro-incisions.
|
PTA Only (CONTROL Arm)
n=37 Participants
Standard Balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care.
Angioplasty: The brand and type of PTA balloon(s) used will be at the discretion of the treating physician and used according to its Instructions for Use (IFU). PTA balloons consist of an over-the-wire catheter with a balloon fixed at the distal tip. Within the lesion the balloon is inflated to a pressure that allows full effacement.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
37 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Weight
|
184 pounds
n=5 Participants
|
171 pounds
n=7 Participants
|
177 pounds
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 DaysDefined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 30 days post- procedure.
Outcome measures
| Measure |
FLEX Vessel Prep System Followed With PTA (TEST Arm)
n=38 Participants
FLEX Vessel Prep System is used to create circumferential, continuous micro-incisions along the length of the stenosis by performing a retrograde pullback through the lesion. Following FLEX, standard balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care.
FLEX Vessel Prep System: The FLEX Vessel Prep System™ is an over-the-wire sheathed catheter with a three-strut treatment element near the distal tip. As the device is pulled back in a retrograde fashion through the target lesion, the Treatment Element "flexes" providing continuous engagement along the lesion to create controlled depth micro-incisions.
|
PTA Only (CONTROL Arm)
n=37 Participants
Standard Balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care.
Angioplasty: The brand and type of PTA balloon(s) used will be at the discretion of the treating physician and used according to its Instructions for Use (IFU). PTA balloons consist of an over-the-wire catheter with a balloon fixed at the distal tip. Within the lesion the balloon is inflated to a pressure that allows full effacement.
|
|---|---|---|
|
Primary Safety Endpoint: Serious Adverse Event Rate
|
0 percentage of patients
|
2.7 percentage of patients
|
Adverse Events
FLEX Vessel Prep System Followed With PTA (TEST Arm)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
PTA Only (CONTROL Arm)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
FLEX Vessel Prep System Followed With PTA (TEST Arm)
n=38 participants at risk
FLEX Vessel Prep System is used to create circumferential, continuous micro-incisions along the length of the stenosis by performing a retrograde pullback through the lesion. Following FLEX, standard balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care.
FLEX Vessel Prep System: The FLEX Vessel Prep System™ is an over-the-wire sheathed catheter with a three-strut treatment element near the distal tip. As the device is pulled back in a retrograde fashion through the target lesion, the Treatment Element "flexes" providing continuous engagement along the lesion to create controlled depth micro-incisions.
|
PTA Only (CONTROL Arm)
n=37 participants at risk
Standard Balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care.
Angioplasty: The brand and type of PTA balloon(s) used will be at the discretion of the treating physician and used according to its Instructions for Use (IFU). PTA balloons consist of an over-the-wire catheter with a balloon fixed at the distal tip. Within the lesion the balloon is inflated to a pressure that allows full effacement.
|
|---|---|---|
|
Vascular disorders
Aneurysm of upper arm
|
0.00%
0/38 • 30 days for primary endpoint
|
2.7%
1/37 • 30 days for primary endpoint
|
Other adverse events
Adverse event data not reported
Additional Information
Vice President, Clinical, Regulatory & Quality
VentureMed Group, Inc.
Phone: 763-296-2021
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place