Trial Outcomes & Findings for Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access (NCT NCT05399680)
NCT ID: NCT05399680
Last Updated: 2025-08-11
Results Overview
Occurrence rate of CEC-adjudicated, major radial access site complications attributed to study device or procedure through time of hospital discharge.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
151 participants
Primary outcome timeframe
From the time of sheath introduction through the radial artery (start time of procedure) through time of discharge (within ~48 hours of end time of procedure) or study exit, whichever comes first
Results posted on
2025-08-11
Participant Flow
A total of 151 enrolled subjects were enrolled between June 29, 2022 and September 22, 2023 at 12 institutions/hospitals across 6 European countries.
Of the 151 total enrolled subjects, 129 subjects belonged to the main cohort while the remaining 22 subjects belonged to a roll-in cohort. The outcomes presented in this record are for EACH of the two cohorts in the Participant Flow, Baseline Characteristics and Adverse Events modules and for the MAIN cohort alone in all other modules (i.e., Outcome Measures).
Participant milestones
| Measure |
Main Cohort
All enrolled subjects were planned to be treated with the SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices.
The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
Roll-in Cohort
A subgroup of 22 subjects, consisting of the first two (2) enrolled subjects at each study site (as applicable), constituted the "roll-in" cohort for the study. Such subjects were pre-specified as "roll-in" subjects prior to their enrollment and met all criteria for enrollment, however, they were also followed up and evaluated up to 30 days post-procedure only for safety and not included in any primary endpoint analyses.
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
22
|
|
Overall Study
COMPLETED
|
128
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Main Cohort
All enrolled subjects were planned to be treated with the SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices.
The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
Roll-in Cohort
A subgroup of 22 subjects, consisting of the first two (2) enrolled subjects at each study site (as applicable), constituted the "roll-in" cohort for the study. Such subjects were pre-specified as "roll-in" subjects prior to their enrollment and met all criteria for enrollment, however, they were also followed up and evaluated up to 30 days post-procedure only for safety and not included in any primary endpoint analyses.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Main Cohort
n=129 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
|
Roll-in Cohort
n=22 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
A subgroup of 22 subjects, consisting of the first two (2) enrolled subjects at each study site (as applicable), constituted the "roll-in" cohort for the study. Such subjects were pre-specified as "roll-in" subjects prior to their enrollment and met all criteria for enrollment, however, they were also followed up and evaluated up to 30 days post-procedure only for safety and not included in any primary endpoint analyses.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.23 Years
STANDARD_DEVIATION 9.44 • n=129 Participants
|
68.45 Years
STANDARD_DEVIATION 8.90 • n=22 Participants
|
68.26 Years
STANDARD_DEVIATION 9.44 • n=151 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=129 Participants
|
3 Participants
n=22 Participants
|
37 Participants
n=151 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=129 Participants
|
19 Participants
n=22 Participants
|
114 Participants
n=151 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Austria
|
43 participants
n=129 Participants
|
8 participants
n=22 Participants
|
51 participants
n=151 Participants
|
|
Region of Enrollment
Italy
|
17 participants
n=129 Participants
|
2 participants
n=22 Participants
|
19 participants
n=151 Participants
|
|
Region of Enrollment
France
|
65 participants
n=129 Participants
|
8 participants
n=22 Participants
|
73 participants
n=151 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=129 Participants
|
2 participants
n=22 Participants
|
6 participants
n=151 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=129 Participants
|
1 participants
n=22 Participants
|
1 participants
n=151 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=129 Participants
|
1 participants
n=22 Participants
|
1 participants
n=151 Participants
|
|
Medical History
COPD
|
15 Participants
n=129 Participants
|
4 Participants
n=22 Participants
|
19 Participants
n=151 Participants
|
|
Medical History
Chronic Renal Failure
|
4 Participants
n=129 Participants
|
4 Participants
n=22 Participants
|
8 Participants
n=151 Participants
|
|
Medical History
Diabetes Mellitus
|
39 Participants
n=129 Participants
|
5 Participants
n=22 Participants
|
44 Participants
n=151 Participants
|
|
Medical History
Heart Failure
|
6 Participants
n=129 Participants
|
1 Participants
n=22 Participants
|
7 Participants
n=151 Participants
|
|
Medical History
Hypercholesterolemia
|
93 Participants
n=129 Participants
|
16 Participants
n=22 Participants
|
109 Participants
n=151 Participants
|
|
Medical History
Hypertension
|
98 Participants
n=129 Participants
|
19 Participants
n=22 Participants
|
117 Participants
n=151 Participants
|
|
Medical History
Peripheral Artery Disease
|
96 Participants
n=129 Participants
|
15 Participants
n=22 Participants
|
111 Participants
n=151 Participants
|
|
Medical History
Previous Cerebrovascular Accident
|
7 Participants
n=129 Participants
|
1 Participants
n=22 Participants
|
8 Participants
n=151 Participants
|
|
Medical History
Previous Myocardial Infarction
|
9 Participants
n=129 Participants
|
1 Participants
n=22 Participants
|
10 Participants
n=151 Participants
|
|
Medical History
Smoking
|
91 Participants
n=129 Participants
|
18 Participants
n=22 Participants
|
109 Participants
n=151 Participants
|
|
Medical History
Smoking Unknown
|
3 Participants
n=129 Participants
|
1 Participants
n=22 Participants
|
4 Participants
n=151 Participants
|
|
Physical Examination Condition
Peripheral Artery Disease Symptoms
|
129 Participants
n=129 Participants
|
21 Participants
n=22 Participants
|
150 Participants
n=151 Participants
|
|
Physical Examination Condition
Claudication Symptoms
|
127 Participants
n=129 Participants
|
20 Participants
n=22 Participants
|
147 Participants
n=151 Participants
|
|
Physical Examination Condition
Muscle Plain with Exercise
|
110 Participants
n=129 Participants
|
17 Participants
n=22 Participants
|
127 Participants
n=151 Participants
|
|
Physical Examination Condition
Critical Limb Symptoms
|
12 Participants
n=129 Participants
|
3 Participants
n=22 Participants
|
15 Participants
n=151 Participants
|
|
Physical Examination Condition
Pain at Rest
|
13 Participants
n=129 Participants
|
1 Participants
n=22 Participants
|
14 Participants
n=151 Participants
|
|
Height (cm)
|
170.48 centimeters
STANDARD_DEVIATION 8.30 • n=129 Participants
|
172.5 centimeters
STANDARD_DEVIATION 9.02 • n=22 Participants
|
170.77 centimeters
STANDARD_DEVIATION 8.41 • n=151 Participants
|
|
Weight (kg)
|
77.01 kg
STANDARD_DEVIATION 14.33 • n=129 Participants
|
82.78 kg
STANDARD_DEVIATION 15.42 • n=22 Participants
|
77.85 kg
STANDARD_DEVIATION 14.59 • n=151 Participants
|
|
Rutherford Class
Class 2 - moderate claudication
|
46 Participants
n=129 Participants
|
5 Participants
n=22 Participants
|
51 Participants
n=151 Participants
|
|
Rutherford Class
Class 3 - Severe Claudication
|
71 Participants
n=129 Participants
|
16 Participants
n=22 Participants
|
87 Participants
n=151 Participants
|
|
Rutherford Class
Class 4 - Ischemic Rest Pain
|
6 Participants
n=129 Participants
|
0 Participants
n=22 Participants
|
6 Participants
n=151 Participants
|
|
Rutherford Class
Class 5 - Minor tissue loss-non healing ulcer, focal gangrene with diffuse pedal ischemia
|
6 Participants
n=129 Participants
|
1 Participants
n=22 Participants
|
7 Participants
n=151 Participants
|
|
Pre-Procedure Stenosis Percent
Reported by Sites
|
82.50 Percent
STANDARD_DEVIATION 11.06 • n=129 Participants
|
81.27 Percent
STANDARD_DEVIATION 12.81 • n=22 Participants
|
81.28 Percent
STANDARD_DEVIATION 11.58 • n=151 Participants
|
|
Pre-Procedure Stenosis Percent
Reported by Core Lab
|
57.56 Percent
STANDARD_DEVIATION 25.46 • n=129 Participants
|
58.05 Percent
STANDARD_DEVIATION 29.21 • n=22 Participants
|
57.63 Percent
STANDARD_DEVIATION 25.94 • n=151 Participants
|
|
Target Lesion Location - Core Lab Reported
Common iliac artery
|
52 Participants
n=129 Participants
|
8 Participants
n=22 Participants
|
60 Participants
n=151 Participants
|
|
Target Lesion Location - Core Lab Reported
Common iliac artery, External iliac artery
|
8 Participants
n=129 Participants
|
6 Participants
n=22 Participants
|
14 Participants
n=151 Participants
|
|
Target Lesion Location - Core Lab Reported
Common iliac artery, Superficial femoral artery
|
0 Participants
n=129 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
|
Target Lesion Location - Core Lab Reported
External iliac artery
|
32 Participants
n=129 Participants
|
3 Participants
n=22 Participants
|
35 Participants
n=151 Participants
|
|
Target Lesion Location - Core Lab Reported
External iliac artery, Superficial femoral artery
|
0 Participants
n=129 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
|
Target Lesion Location - Core Lab Reported
Proximal popliteal artery
|
0 Participants
n=129 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=151 Participants
|
|
Target Lesion Location - Core Lab Reported
Superficial femoral artery
|
36 Participants
n=129 Participants
|
3 Participants
n=22 Participants
|
39 Participants
n=151 Participants
|
|
Target Lesion Location - Core Lab Reported
Not Stated
|
1 Participants
n=129 Participants
|
1 Participants
n=22 Participants
|
2 Participants
n=151 Participants
|
|
Lesion Length Characteristic - Core Lab Reported
|
47.58 mm
STANDARD_DEVIATION 44.32 • n=129 Participants
|
54.32 mm
STANDARD_DEVIATION 47.68 • n=22 Participants
|
48.72 mm
STANDARD_DEVIATION 44.78 • n=151 Participants
|
|
Calcification Category - Core Lab Reported
Severe
|
50 Participants
n=129 Participants
|
14 Participants
n=22 Participants
|
64 Participants
n=151 Participants
|
|
Calcification Category - Core Lab Reported
Non-Severe
|
26 Participants
n=129 Participants
|
2 Participants
n=22 Participants
|
28 Participants
n=151 Participants
|
|
Calcification Category - Core Lab Reported
No calcification
|
48 Participants
n=129 Participants
|
6 Participants
n=22 Participants
|
54 Participants
n=151 Participants
|
|
Calcification Category - Core Lab Reported
Not Stated
|
5 Participants
n=129 Participants
|
0 Participants
n=22 Participants
|
5 Participants
n=151 Participants
|
|
Radial Artery Diameter by Ultrasound - Site Reported (mm)
|
3.10 mm
STANDARD_DEVIATION 0.65 • n=127 Participants • Missing data
|
2.94 mm
STANDARD_DEVIATION 0.45 • n=22 Participants • Missing data
|
3.07 mm
STANDARD_DEVIATION 0.63 • n=149 Participants • Missing data
|
PRIMARY outcome
Timeframe: From the time of sheath introduction through the radial artery (start time of procedure) through time of discharge (within ~48 hours of end time of procedure) or study exit, whichever comes firstPopulation: Intent-to-treat population of the main cohort
Occurrence rate of CEC-adjudicated, major radial access site complications attributed to study device or procedure through time of hospital discharge.
Outcome measures
| Measure |
Interventional
n=129 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Occurrence Rate of Radial Access Site Complications (Primary Safety Outcome)
|
0 Participants
|
PRIMARY outcome
Timeframe: From the time of insertion to the time of withdrawal of the SMART RADIANZ Vascular Stent System through the radial access artery, within the same day or 24 hours from the procedure start timePopulation: Intent-to-treat population of the main cohort
Technical success at the conclusion of the index procedure, defined as successful insertion of the S.M.A.R.T. RADIANZ™ Vascular Stent System into the peripheral vasculature through the radial artery, successful deployment of the study device (S.M.A.R.T.™ stent) at the intended location, and successful withdrawal of the delivery system without conversion from radial to femoral artery access.
Outcome measures
| Measure |
Interventional
n=123 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Technical Success of Using the S.M.A.R.T. RADIANZ™ Vascular Stent System (Primary Efficacy Outcome)
|
122 Participants
|
SECONDARY outcome
Timeframe: From the time of first use/handling of the device to 30 days from date of index procedure or study exit, whichever comes firstPopulation: Intent to Treat population of the main cohort. Use of the SMART RADIANZ and SABERX RADIANZ devices was not attempted in all 129 main cohort subjects.
For each of the three (3) devices, peri-procedural (within 30 days post-index procedure) rate of device deficiencies
Outcome measures
| Measure |
Interventional
n=129 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Device Deficiencies Through 30 Days Post-Procedure
BRITE TIP RADIANZ
|
1 Participants
|
|
Device Deficiencies Through 30 Days Post-Procedure
SMART RADIANZ
|
1 Participants
|
|
Device Deficiencies Through 30 Days Post-Procedure
SABERX RADIANZ
|
0 Participants
|
SECONDARY outcome
Timeframe: From the time of introduction of the sheath through the radial access artery to 30 days from date of index procedure or study exit, whichever comes firstPopulation: Intent to Treat population of the main cohort
Peri-procedural (within 30 days post-index procedure) rate of adverse events
Outcome measures
| Measure |
Interventional
n=129 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Adverse Events Through 30 Days Post-Procedure
|
24 Participants
|
SECONDARY outcome
Timeframe: From the time of introduction of the sheath through the radial access artery to 30 days from date of index procedure or study exit, whichever comes firstPopulation: Intent to Treat population of the main cohort
Peri-procedural (within 30 days post-index procedure) rate of death, index limb amputation and target lesion revascularization
Outcome measures
| Measure |
Interventional
n=129 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Death, Index Limb Amputation and TLR Through 30 Days Post-Procedure
Death
|
0 Participants
|
|
Death, Index Limb Amputation and TLR Through 30 Days Post-Procedure
Index Limb Amputation
|
1 Participants
|
|
Death, Index Limb Amputation and TLR Through 30 Days Post-Procedure
Target Lesion Revascularization
|
0 Participants
|
SECONDARY outcome
Timeframe: From the time of introduction of the sheath through the radial access artery to 30 days from date of index procedure or study exit, whichever comes firstPopulation: Intent to Treat population of the main cohort. The number analyzed is less than 129 in some of the rows below due to the fact that SMART RADIANZ and SABERX RADIANZ devices were not attempted to be used in all 129 main cohort subjects and due to missing data.
Peri-procedural (within 30 days post-index procedure) rate of procedural complications
Outcome measures
| Measure |
Interventional
n=129 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Procedural Complications Through 30 Days Post-Procedure
No Conversion from Radial Artery
|
128 Participants
|
|
Procedural Complications Through 30 Days Post-Procedure
BRITE TIP RADIANZ Insertion
|
129 Participants
|
|
Procedural Complications Through 30 Days Post-Procedure
Guidewire Across Target Lesion
|
129 Participants
|
|
Procedural Complications Through 30 Days Post-Procedure
SABERX RADIANZ Insertion
|
128 Participants
|
|
Procedural Complications Through 30 Days Post-Procedure
Balloon Inflation
|
113 Participants
|
|
Procedural Complications Through 30 Days Post-Procedure
S.M.A.R.T. RADIANZ Insertion
|
123 Participants
|
|
Procedural Complications Through 30 Days Post-Procedure
Stent Deployed
|
117 Participants
|
SECONDARY outcome
Timeframe: From the time of insertion through the time of withdrawal of the BRITE TIP RADIANZ™ Guiding Sheath through the radial access artery, assessed within the same day or 24 hours from the start time of the index procedure.Population: Intent to Treat population of the main cohort
Technical success associated with use of the BRITE TIP RADIANZ™ Guiding Sheath, defined as successful insertion of the device into the peripheral vasculature through the radial artery (allowing for introduction of interventional and/or diagnostic devices) and successful withdrawal of the device.
Outcome measures
| Measure |
Interventional
n=129 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Technical Success of Using the BRITE TIP RADIANZ™ Guiding Sheath
|
129 Participants
|
SECONDARY outcome
Timeframe: From the time of insertion to the time of withdrawal of the SABERX RADIANZ™ PTA Balloon Catheter through the radial access artery AND assessment of the final residual diameter stenosis, within the same day or 24 hours from the procedure start timePopulation: There were 95 subjects with a complete set of available data to allow for endpoint analysis on the SABERX RADIANZ device.
Procedural success associated with use of the SABERX RADIANZ™ PTA Balloon Catheter for pre-dilation and/or post-deployment stent dilatation (whenever applicable), defined as successful insertion of the device into the peripheral vasculature through the radial artery, successful inflation and deflation of the balloon, successful withdrawal of the device, and achievement of a final residual diameter stenosis of \< 30% at the conclusion of the index procedure.
Outcome measures
| Measure |
Interventional
n=95 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Procedural Success of Using the SABERX RADIANZ™ PTA Balloon Catheter
|
79 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the start time to the end time of the period during which x-rays are produced, within the same day or 24 hours from the procedure start timePopulation: Intent to Treat population of the main cohort
Fluoroscopy time is the length of time during which X-rays are produced during a fluoroscopy procedure.
Outcome measures
| Measure |
Interventional
n=129 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Fluoroscopy Time
|
9 minutes
Standard Deviation 4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the time of removal of the BRITE TIP RADIANZ Guiding Sheath to when hemostasis was first observed, within the same day or 24 hours from the procedure start timePopulation: Intent to Treat population of the main cohort
Time to achieve hemostasis defined as the time elapsed from removal of the BRITE TIP RADIANZTM Guiding Sheath to the time that hemostasis was first observed.
Outcome measures
| Measure |
Interventional
n=129 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Time to Achieve Hemostasis
|
47 minutes
Standard Deviation 20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the time of vascular closure to the time of ambulation, within the same day or 24 hours from the procedure start time, or study exit, whichever comes firstPopulation: Intent to Treat population of the main cohort. The Overall Number of Participants Analyzed is less than the total for the main cohort due to the unavailability of data.
Time to ambulation, defined as the time from when vascular closure was achieved to when the subject could stand up and walk any distance
Outcome measures
| Measure |
Interventional
n=40 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Time to Ambulation
|
207 minutes
Standard Deviation 153
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the time of vascular closure to the time of hospital discharge (~ up to 1 week from date of index procedure) or study exit, whichever comes firstPopulation: Intent to Treat population of the main cohort. Outlier values noted for two subjects in the main cohort were removed.
Time to hospital discharge
Outcome measures
| Measure |
Interventional
n=127 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Time to Hospital Discharge
|
15.6 hours
Standard Deviation 9.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the time of removing the BRITE TIP RADIANZ Guiding Sheath to the time of either removing the vascular closure device or ending manual compression, within the same day or 24 hours from the procedure start timePopulation: Intent to Treat population of the main cohort
Method to achieve closure of the transradial artery access site
Outcome measures
| Measure |
Interventional
n=129 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Method to Achieve Closure of the Transradial Artery Access Site
Manual Compression
|
2 Participants
|
|
Method to Achieve Closure of the Transradial Artery Access Site
Radial Compression Band
|
127 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening is up to 7 days prior to the index procedure date; discharge is between end of index procedure and 7 days post-discharge; the 30-day follow-up visit is between 23 and 37 days post-procedure, or until time of study exit (whichever comes first)Population: Intent to Treat population of the main cohort
Mean scores are reported on a scale entitled "mean score" and range from 0 (minimum) to 100 (maximum); higher scores represent a better outcome.
Outcome measures
| Measure |
Interventional
n=129 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Quality of Life Assessed Via the SF-36 Questionnaires - General Health
30 Day Follow-Up
|
60.71 score on a scale
Standard Deviation 16.43
|
|
Quality of Life Assessed Via the SF-36 Questionnaires - General Health
Screening
|
47.56 score on a scale
Standard Deviation 17.67
|
|
Quality of Life Assessed Via the SF-36 Questionnaires - General Health
Discharge
|
52.44 score on a scale
Standard Deviation 15.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening is up to 7 days prior to the index procedure date; discharge is between end of index procedure and 7 days post-discharge; the 30-day follow-up visit is between 23 and 37 days post-procedure, or until time of study exit (whichever comes first)Population: Intent to Treat population of the main cohort
The EQ-5D questionnaire is an instrument designed to assess quality of life along five (5) dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each participant, a value-based scoring system is used to convert the combination of their responses to the five individual subscales into a single index value (or a code), which is then converted into a single score based on how people in the participant's country rate different combinations of problems. The EQ-5D score for Overall Health is reported as a mean and standard deviation at screening, discharge and 30 days in this module and ranges from 0 (minimum) to 100 (maximum) with higher scores representing better outcomes.
Outcome measures
| Measure |
Interventional
n=129 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Quality of Life Assessed Via the EuroQOL-5 Dimensions (EQ-5D) Questionnaire - Overall Health
Screening
|
63.20 score on a scale
Standard Deviation 16.24
|
|
Quality of Life Assessed Via the EuroQOL-5 Dimensions (EQ-5D) Questionnaire - Overall Health
Discharge
|
70.66 score on a scale
Standard Deviation 14.08
|
|
Quality of Life Assessed Via the EuroQOL-5 Dimensions (EQ-5D) Questionnaire - Overall Health
30 Day
|
78.01 score on a scale
Standard Deviation 13.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the time of vascular closure to the time of hospital discharge eligibility (~ up to 1 week from date of index procedure) or study exit, whichever comes firstPopulation: Intent to Treat population of the main cohort. The Overall Number of Participants Analyzed is less than the total number of participants in the main cohort due to the unavailability of data.
Time to hospital discharge eligibility (when physician examines and if all is well, gives discharge orders)
Outcome measures
| Measure |
Interventional
n=39 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Time to Hospital Discharge Eligibility
|
14.3 hours
Standard Deviation 10.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the time of introduction of the sheath through the radial access artery to the time of vascular closure, within the same day or 24 hours from the procedure start timePopulation: Intent to Treat population of the main cohort
Procedural Time is defined as the time elapsed from when the sheath was introduced through the radial access artery to the time of vascular closure.
Outcome measures
| Measure |
Interventional
n=129 Participants
Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
S.M.A.R.T. RADIANZ™ Vascular Stent System: The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding Sheath: BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon Catheter: SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
|
|---|---|
|
Procedural Time
|
47 minutes
Standard Deviation 20
|
Adverse Events
Main Cohort
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Roll-in Cohort
Serious events: 6 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Main Cohort
n=129 participants at risk
The main cohort consisted of 129 of the 151 total enrolled subjects in the study.
|
Roll-in Cohort
n=22 participants at risk
The roll-in cohort was a subgroup of 22 of the 151 total enrolled subjects. The roll-in cohort consisted of the first two (2) enrolled subjects at each study site (as applicable). Such subjects were pre-specified as "roll-in" subjects prior to their enrollment and met all criteria for enrollment, however, they were also followed up and evaluated up to 30 days post-procedure only for safety and not included in any primary endpoint analyses.
|
|---|---|---|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.78%
1/129 • Number of events 1 • Peri-procedural (within 30 days post-index procedure)
|
0.00%
0/22 • Peri-procedural (within 30 days post-index procedure)
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.78%
1/129 • Number of events 1 • Peri-procedural (within 30 days post-index procedure)
|
0.00%
0/22 • Peri-procedural (within 30 days post-index procedure)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.78%
1/129 • Number of events 1 • Peri-procedural (within 30 days post-index procedure)
|
0.00%
0/22 • Peri-procedural (within 30 days post-index procedure)
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.78%
1/129 • Number of events 1 • Peri-procedural (within 30 days post-index procedure)
|
0.00%
0/22 • Peri-procedural (within 30 days post-index procedure)
|
|
Vascular disorders
Ischaemia
|
0.78%
1/129 • Number of events 1 • Peri-procedural (within 30 days post-index procedure)
|
0.00%
0/22 • Peri-procedural (within 30 days post-index procedure)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/129 • Peri-procedural (within 30 days post-index procedure)
|
9.1%
2/22 • Number of events 2 • Peri-procedural (within 30 days post-index procedure)
|
|
Cardiac disorders
Iliac artery perforation
|
0.00%
0/129 • Peri-procedural (within 30 days post-index procedure)
|
4.5%
1/22 • Number of events 1 • Peri-procedural (within 30 days post-index procedure)
|
|
General disorders
Ulcer
|
0.00%
0/129 • Peri-procedural (within 30 days post-index procedure)
|
4.5%
1/22 • Number of events 1 • Peri-procedural (within 30 days post-index procedure)
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/129 • Peri-procedural (within 30 days post-index procedure)
|
4.5%
1/22 • Number of events 1 • Peri-procedural (within 30 days post-index procedure)
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/129 • Peri-procedural (within 30 days post-index procedure)
|
4.5%
1/22 • Number of events 1 • Peri-procedural (within 30 days post-index procedure)
|
Other adverse events
| Measure |
Main Cohort
n=129 participants at risk
The main cohort consisted of 129 of the 151 total enrolled subjects in the study.
|
Roll-in Cohort
n=22 participants at risk
The roll-in cohort was a subgroup of 22 of the 151 total enrolled subjects. The roll-in cohort consisted of the first two (2) enrolled subjects at each study site (as applicable). Such subjects were pre-specified as "roll-in" subjects prior to their enrollment and met all criteria for enrollment, however, they were also followed up and evaluated up to 30 days post-procedure only for safety and not included in any primary endpoint analyses.
|
|---|---|---|
|
General disorders
Vascular access site haematoma
|
7.8%
10/129 • Number of events 10 • Peri-procedural (within 30 days post-index procedure)
|
0.00%
0/22 • Peri-procedural (within 30 days post-index procedure)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication, provided that those comments do not jeopardize the scientific integrity of the publication.
- Publication restrictions are in place
Restriction type: OTHER