Peripheral Arterial Disease
Conditions
Brief summary
The primary objective of this clinical investigation was to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ Nitinol Stent, in the treatment of patients with obstructive iliac or femoropopliteal arterial disease via radial artery access.
Detailed description
RADIANCY was an acute, multi-center, single-arm, non-randomized, prospective, pivotal (pre-market) clinical study, whose primary objective was to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ self-expanding stent in the treatment of patients with obstructive iliac or femoropopliteal arterial disease via transradial artery access. The study enrolled 151 subjects, 22 of which were enrolled as roll-in subjects, at 12 investigational sites across Europe. These subjects were followed up to 30 days post-procedure.
Interventions
DEVICES.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.
DEVICEBRITE 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.
DEVICESABERX RADIANZ™ PTA Balloon Catheter
SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
Sponsors
Qserve
NAMSA
Cordis US Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet ALL of the following inclusion criteria to be enrolled in the study: ALL patients must meet the following criteria prior to enrollment: 1. Age ≥ 18 years 2. For women of child-bearing potential, a negative pregnancy test within seven (7) days prior to the index procedure 3. Symptomatic leg ischemia or ischemic ulcerations that do NOT exceed digits of the foot (Rutherford/Becker Classification category 2, 3, 4 or 5) 4. Palpable radial artery with diameter ≥ 2.5 mm, as assessed by duplex ultrasound 5. Eligibility for standard surgical repair, if necessary 6. A patient who requires a coronary intervention should have it performed at least seven (7) days prior to treatment of the target lesion 7. The patient must provide documented informed consent and any other documented authorization, as required, prior to initiation of the study procedure 8. Per Investigator assessment, the patient is willing and able to be followed up to 30 days post-procedure for evaluation and complete all required assessments per the study protocol. Inclusion criteria 9 and 10 AND 11a through 14a OR 11b through 16b (whichever is applicable) would be assessed via baseline angiography performed at the time of index procedure: 9. The Investigator has assessed that the patient is a suitable candidate (i.e, meets all inclusion criteria and none of the
Exclusion criteria
), for treatment of a lesion in the iliac, superficial femoral and/or proximal popliteal arteries via transradial approach and is eligible for conversion from a transradial to transfemoral approach, if it becomes necessary. 10. The guidewire is across the target lesion(s) and located intraluminally within the distal vessel following a transradial approach Patients whose target lesion is in the iliac artery must meet these additional criteria prior to enrollment: 11a. A single de novo or restenotic lesion ≥ 50% stenosis in the common and/or external iliac artery 12a. Stenotic lesion (one long or multiple serial/tandem lesions) less than or equal to 100 mm, by visual assessment, within or across the common or external iliac arteries. The stenosis must be treatable with no more than two stents (while minimizing stent overlap) 13a. Reference vessel diameter (RVD) ranging from 4.0 to 9.0 mm by visual assessment 14a. Angiographic evidence of a patent profunda or superficial femoral artery in the diseased (target) limb Patients whose target lesion is in the SFA and/or PPA must meet these additional criteria prior to enrollment: 11b. A single de novo or restenotic lesion ≥ 50% stenosis in the SFA and/or PPA 12b. Stenotic lesion (one long or multiple serial/tandem lesions) less than or equal to 150 mm, by visual assessment, within or across the SFA and/or PPA. The stenosis must be treatable with no more than two stents (while minimizing stent overlap) 13b. RVD ranging from 4.0 to 7.0 mm by visual assessment 14b. All lesions are to be located at least three centimeters proximal to the superior edge of the patella 15b. Patent infrapopliteal artery, i.e., single vessel runoff or better with patency (\<50% stenosis) of at least one of three vessels to the ankle or foot 16b. Adequate aortoiliac or common femoral inflow (defined as \< 30% stenosis after PTA or stenting) prior to treatment of the target lesion (defined as \< 30% stenosis after PTA or stenting) prior to treatment of the target lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence Rate of Radial Access Site Complications (Primary Safety Outcome) | 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 | Occurrence rate of CEC-adjudicated, major radial access site complications attributed to study device or procedure through time of hospital discharge. |
| Technical Success of Using the S.M.A.R.T. RADIANZ™ Vascular Stent System (Primary Efficacy Outcome) | 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 time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death, Index Limb Amputation and TLR Through 30 Days Post-Procedure | 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 first | Peri-procedural (within 30 days post-index procedure) rate of death, index limb amputation and target lesion revascularization |
| Procedural Complications Through 30 Days Post-Procedure | 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 first | Peri-procedural (within 30 days post-index procedure) rate of procedural complications |
| Device Deficiencies Through 30 Days Post-Procedure | From the time of first use/handling of the device to 30 days from date of index procedure or study exit, whichever comes first | For each of the three (3) devices, peri-procedural (within 30 days post-index procedure) rate of device deficiencies |
| Procedural Success of Using the SABERX RADIANZ™ PTA Balloon Catheter | 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 time | 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. |
| Technical Success of Using the BRITE TIP RADIANZ™ Guiding Sheath | 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. | 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. |
| Adverse Events Through 30 Days Post-Procedure | 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 first | Peri-procedural (within 30 days post-index procedure) rate of adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Method to Achieve Closure of the Transradial Artery Access Site | 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 time | Method to achieve closure of the transradial artery access site |
| Procedural Time | 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 time | 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. |
| Fluoroscopy Time | 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 time | Fluoroscopy time is the length of time during which X-rays are produced during a fluoroscopy procedure. |
| Time to Achieve Hemostasis | 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 time | 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. |
| Time to Ambulation | 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 first | Time to ambulation, defined as the time from when vascular closure was achieved to when the subject could stand up and walk any distance |
| Time to Hospital Discharge | 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 first | Time to hospital discharge |
| Quality of Life Assessed Via the SF-36 Questionnaires - General Health | 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) | Mean scores are reported on a scale entitled mean score and range from 0 (minimum) to 100 (maximum); higher scores represent a better outcome. |
| Quality of Life Assessed Via the EuroQOL-5 Dimensions (EQ-5D) Questionnaire - Overall Health | 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) | 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. |
| Time to Hospital Discharge Eligibility | 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 first | Time to hospital discharge eligibility (when physician examines and if all is well, gives discharge orders) |
Countries
Austria, Belgium, France, Italy, Spain, Switzerland
Participant flow
Recruitment details
A total of 151 enrolled subjects were enrolled between June 29, 2022 and September 22, 2023 at 12 institutions/hospitals across 6 European countries.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Main Cohort Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices | 129 |
| Roll-in Cohort 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. | 22 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Roll-in Cohort | Total | Main Cohort |
|---|---|---|---|
| Age, Continuous | 68.45 Years STANDARD_DEVIATION 8.9 | 68.26 Years STANDARD_DEVIATION 9.44 | 68.23 Years STANDARD_DEVIATION 9.44 |
| Calcification Category - Core Lab Reported No calcification | 6 Participants | 54 Participants | 48 Participants |
| Calcification Category - Core Lab Reported Non-Severe | 2 Participants | 28 Participants | 26 Participants |
| Calcification Category - Core Lab Reported Not Stated | 0 Participants | 5 Participants | 5 Participants |
| Calcification Category - Core Lab Reported Severe | 14 Participants | 64 Participants | 50 Participants |
| Height (cm) | 172.5 centimeters STANDARD_DEVIATION 9.02 | 170.77 centimeters STANDARD_DEVIATION 8.41 | 170.48 centimeters STANDARD_DEVIATION 8.3 |
| Lesion Length Characteristic - Core Lab Reported | 54.32 mm STANDARD_DEVIATION 47.68 | 48.72 mm STANDARD_DEVIATION 44.78 | 47.58 mm STANDARD_DEVIATION 44.32 |
| Medical History Chronic Renal Failure | 4 Participants | 8 Participants | 4 Participants |
| Medical History COPD | 4 Participants | 19 Participants | 15 Participants |
| Medical History Diabetes Mellitus | 5 Participants | 44 Participants | 39 Participants |
| Medical History Heart Failure | 1 Participants | 7 Participants | 6 Participants |
| Medical History Hypercholesterolemia | 16 Participants | 109 Participants | 93 Participants |
| Medical History Hypertension | 19 Participants | 117 Participants | 98 Participants |
| Medical History Peripheral Artery Disease | 15 Participants | 111 Participants | 96 Participants |
| Medical History Previous Cerebrovascular Accident | 1 Participants | 8 Participants | 7 Participants |
| Medical History Previous Myocardial Infarction | 1 Participants | 10 Participants | 9 Participants |
| Medical History Smoking | 18 Participants | 109 Participants | 91 Participants |
| Medical History Smoking Unknown | 1 Participants | 4 Participants | 3 Participants |
| Physical Examination Condition Claudication Symptoms | 20 Participants | 147 Participants | 127 Participants |
| Physical Examination Condition Critical Limb Symptoms | 3 Participants | 15 Participants | 12 Participants |
| Physical Examination Condition Muscle Plain with Exercise | 17 Participants | 127 Participants | 110 Participants |
| Physical Examination Condition Pain at Rest | 1 Participants | 14 Participants | 13 Participants |
| Physical Examination Condition Peripheral Artery Disease Symptoms | 21 Participants | 150 Participants | 129 Participants |
| Pre-Procedure Stenosis Percent Reported by Core Lab | 58.05 Percent STANDARD_DEVIATION 29.21 | 57.63 Percent STANDARD_DEVIATION 25.94 | 57.56 Percent STANDARD_DEVIATION 25.46 |
| Pre-Procedure Stenosis Percent Reported by Sites | 81.27 Percent STANDARD_DEVIATION 12.81 | 81.28 Percent STANDARD_DEVIATION 11.58 | 82.50 Percent STANDARD_DEVIATION 11.06 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Radial Artery Diameter by Ultrasound - Site Reported (mm) | 2.94 mm STANDARD_DEVIATION 0.45 | 3.07 mm STANDARD_DEVIATION 0.63 | 3.10 mm STANDARD_DEVIATION 0.65 |
| Region of Enrollment Austria | 8 participants | 51 participants | 43 participants |
| Region of Enrollment Belgium | 1 participants | 1 participants | 0 participants |
| Region of Enrollment France | 8 participants | 73 participants | 65 participants |
| Region of Enrollment Italy | 2 participants | 19 participants | 17 participants |
| Region of Enrollment Spain | 2 participants | 6 participants | 4 participants |
| Region of Enrollment Switzerland | 1 participants | 1 participants | 0 participants |
| Rutherford Class Class 2 - moderate claudication | 5 Participants | 51 Participants | 46 Participants |
| Rutherford Class Class 3 - Severe Claudication | 16 Participants | 87 Participants | 71 Participants |
| Rutherford Class Class 4 - Ischemic Rest Pain | 0 Participants | 6 Participants | 6 Participants |
| Rutherford Class Class 5 - Minor tissue loss-non healing ulcer, focal gangrene with diffuse pedal ischemia | 1 Participants | 7 Participants | 6 Participants |
| Sex: Female, Male Female | 3 Participants | 37 Participants | 34 Participants |
| Sex: Female, Male Male | 19 Participants | 114 Participants | 95 Participants |
| Target Lesion Location - Core Lab Reported Common iliac artery | 8 Participants | 60 Participants | 52 Participants |
| Target Lesion Location - Core Lab Reported Common iliac artery, External iliac artery | 6 Participants | 14 Participants | 8 Participants |
| Target Lesion Location - Core Lab Reported Common iliac artery, Superficial femoral artery | 0 Participants | 0 Participants | 0 Participants |
| Target Lesion Location - Core Lab Reported External iliac artery | 3 Participants | 35 Participants | 32 Participants |
| Target Lesion Location - Core Lab Reported External iliac artery, Superficial femoral artery | 0 Participants | 0 Participants | 0 Participants |
| Target Lesion Location - Core Lab Reported Not Stated | 1 Participants | 2 Participants | 1 Participants |
| Target Lesion Location - Core Lab Reported Proximal popliteal artery | 1 Participants | 1 Participants | 0 Participants |
| Target Lesion Location - Core Lab Reported Superficial femoral artery | 3 Participants | 39 Participants | 36 Participants |
| Weight (kg) | 82.78 kg STANDARD_DEVIATION 15.42 | 77.85 kg STANDARD_DEVIATION 14.59 | 77.01 kg STANDARD_DEVIATION 14.33 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 129 | 1 / 22 |
| other Total, other adverse events | 10 / 129 | 0 / 22 |
| serious Total, serious adverse events | 5 / 129 | 6 / 22 |
Outcome results
Primary
Occurrence Rate of Radial Access Site Complications (Primary Safety Outcome)
Occurrence rate of CEC-adjudicated, major radial access site complications attributed to study device or procedure through time of hospital discharge.
Time frame: 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
Population: Intent-to-treat population of the main cohort
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional | Occurrence Rate of Radial Access Site Complications (Primary Safety Outcome) | 0 Participants |
Primary
Technical Success of Using the S.M.A.R.T. RADIANZ™ Vascular Stent System (Primary Efficacy Outcome)
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.
Time frame: 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 time
Population: Intent-to-treat population of the main cohort
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional | Technical Success of Using the S.M.A.R.T. RADIANZ™ Vascular Stent System (Primary Efficacy Outcome) | 122 Participants |
Secondary
Adverse Events Through 30 Days Post-Procedure
Peri-procedural (within 30 days post-index procedure) rate of adverse events
Time frame: 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 first
Population: Intent to Treat population of the main cohort
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional | Adverse Events Through 30 Days Post-Procedure | 24 Participants |
Secondary
Death, Index Limb Amputation and TLR Through 30 Days Post-Procedure
Peri-procedural (within 30 days post-index procedure) rate of death, index limb amputation and target lesion revascularization
Time frame: 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 first
Population: Intent to Treat population of the main cohort
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional | Death, Index Limb Amputation and TLR Through 30 Days Post-Procedure | Death | 0 Participants |
| Interventional | Death, Index Limb Amputation and TLR Through 30 Days Post-Procedure | Index Limb Amputation | 1 Participants |
| Interventional | Death, Index Limb Amputation and TLR Through 30 Days Post-Procedure | Target Lesion Revascularization | 0 Participants |
Secondary
Device Deficiencies Through 30 Days Post-Procedure
For each of the three (3) devices, peri-procedural (within 30 days post-index procedure) rate of device deficiencies
Time frame: From the time of first use/handling of the device to 30 days from date of index procedure or study exit, whichever comes first
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional | Device Deficiencies Through 30 Days Post-Procedure | BRITE TIP RADIANZ | 1 Participants |
| Interventional | Device Deficiencies Through 30 Days Post-Procedure | SMART RADIANZ | 1 Participants |
| Interventional | Device Deficiencies Through 30 Days Post-Procedure | SABERX RADIANZ | 0 Participants |
Secondary
Procedural Complications Through 30 Days Post-Procedure
Peri-procedural (within 30 days post-index procedure) rate of procedural complications
Time frame: 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 first
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional | Procedural Complications Through 30 Days Post-Procedure | Balloon Inflation | 113 Participants |
| Interventional | Procedural Complications Through 30 Days Post-Procedure | No Conversion from Radial Artery | 128 Participants |
| Interventional | Procedural Complications Through 30 Days Post-Procedure | BRITE TIP RADIANZ Insertion | 129 Participants |
| Interventional | Procedural Complications Through 30 Days Post-Procedure | Guidewire Across Target Lesion | 129 Participants |
| Interventional | Procedural Complications Through 30 Days Post-Procedure | SABERX RADIANZ Insertion | 128 Participants |
| Interventional | Procedural Complications Through 30 Days Post-Procedure | S.M.A.R.T. RADIANZ Insertion | 123 Participants |
| Interventional | Procedural Complications Through 30 Days Post-Procedure | Stent Deployed | 117 Participants |
Secondary
Procedural Success of Using the SABERX RADIANZ™ PTA Balloon Catheter
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.
Time frame: 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 time
Population: There were 95 subjects with a complete set of available data to allow for endpoint analysis on the SABERX RADIANZ device.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional | Procedural Success of Using the SABERX RADIANZ™ PTA Balloon Catheter | 79 Participants |
Secondary
Technical Success of Using the BRITE TIP RADIANZ™ Guiding Sheath
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional | Technical Success of Using the BRITE TIP RADIANZ™ Guiding Sheath | 129 Participants |
Other Pre-specified
Fluoroscopy Time
Fluoroscopy time is the length of time during which X-rays are produced during a fluoroscopy procedure.
Time frame: 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 time
Population: Intent to Treat population of the main cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional | Fluoroscopy Time | 9 minutes | Standard Deviation 4 |
Other Pre-specified
Method to Achieve Closure of the Transradial Artery Access Site
Method to achieve closure of the transradial artery access site
Time frame: 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 time
Population: Intent to Treat population of the main cohort
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional | Method to Achieve Closure of the Transradial Artery Access Site | Manual Compression | 2 Participants |
| Interventional | Method to Achieve Closure of the Transradial Artery Access Site | Radial Compression Band | 127 Participants |
Other Pre-specified
Procedural Time
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.
Time frame: 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 time
Population: Intent to Treat population of the main cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional | Procedural Time | 47 minutes | Standard Deviation 20 |
Other Pre-specified
Quality of Life Assessed Via the EuroQOL-5 Dimensions (EQ-5D) Questionnaire - Overall Health
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional | 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 |
| Interventional | 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 |
| Interventional | 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
Quality of Life Assessed Via the SF-36 Questionnaires - General Health
Mean scores are reported on a scale entitled mean score and range from 0 (minimum) to 100 (maximum); higher scores represent a better outcome.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional | Quality of Life Assessed Via the SF-36 Questionnaires - General Health | Screening | 47.56 score on a scale | Standard Deviation 17.67 |
| Interventional | Quality of Life Assessed Via the SF-36 Questionnaires - General Health | Discharge | 52.44 score on a scale | Standard Deviation 15.1 |
| Interventional | 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 |
Other Pre-specified
Time to Achieve Hemostasis
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.
Time frame: 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 time
Population: Intent to Treat population of the main cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional | Time to Achieve Hemostasis | 47 minutes | Standard Deviation 20 |
Other Pre-specified
Time to Ambulation
Time to ambulation, defined as the time from when vascular closure was achieved to when the subject could stand up and walk any distance
Time frame: 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 first
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional | Time to Ambulation | 207 minutes | Standard Deviation 153 |
Other Pre-specified
Time to Hospital Discharge
Time to hospital discharge
Time frame: 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 first
Population: Intent to Treat population of the main cohort. Outlier values noted for two subjects in the main cohort were removed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional | Time to Hospital Discharge | 15.6 hours | Standard Deviation 9.5 |
Other Pre-specified
Time to Hospital Discharge Eligibility
Time to hospital discharge eligibility (when physician examines and if all is well, gives discharge orders)
Time frame: 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 first
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interventional | Time to Hospital Discharge Eligibility | 14.3 hours | Standard Deviation 10.1 |