Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIA... | NCT05399680

NCT05399680

Status Module

Sponsor/Collaborators Module

Name	Class
Qserve	INDUSTRY
NAMSA	OTHER

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional	Experimental	Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices	Device: S.M.A.R.T. RADIANZ™ Vascular Stent System Device: BRITE TIP RADIANZ™ Guiding Sheath Device: SABERX RADIANZ™ PTA Balloon Catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S.M.A.R.T. RADIANZ™ Vascular Stent System	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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
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.	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

Secondary Outcomes

Measure	Description	Time Frame
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	From the time of first use/handling of the device to 30 days from date of index procedure or study exit, whichever comes first
Adverse Events Through 30 Days Post-Procedure

Other Outcomes

Measure	Description	Time Frame
Fluoroscopy Time	Fluoroscopy time is the length of time during which X-rays are produced during a fluoroscopy procedure.	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
Time to Achieve Hemostasis

Eligibility Module

Eligibility Criteria

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:

Age ≥ 18 years
For women of child-bearing potential, a negative pregnancy test within seven (7) days prior to the index procedure
Symptomatic leg ischemia or ischemic ulcerations that do NOT exceed digits of the foot (Rutherford/Becker Classification category 2, 3, 4 or 5)
Palpable radial artery with diameter ≥ 2.5 mm, as assessed by duplex ultrasound
Eligibility for standard surgical repair, if necessary
A patient who requires a coronary intervention should have it performed at least seven (7) days prior to treatment of the target lesion
The patient must provide documented informed consent and any other documented authorization, as required, prior to initiation of the study procedure
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:
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.
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

Exclusion Criteria:

Patients will be excluded if ANY of the following exclusion criteria apply:

The patient has had/experienced any prior intervention/treatment to the target vessel within 90 days prior to enrollment (e.g., previously implanted graft in the aorta or target vessel; stroke; cryoplasty, laser or atherectomy; abdominal aortic aneurysm or aneurysm of the iliac, superficial femoral or popliteal artery).
Previously deployed stent at the site of the target lesion
The patient has post-surgical stenosis and anastomotic suture treatments of the target vessel
Requires general anesthesia for percutaneous transluminal angioplasty (PTA) and/or the stenting procedure
Use of mechanical devices on or thrombolysis of the target vessel within 72 hours prior to the index procedure without complete resolution of the thrombus
The patient is receiving any form of dialysis.
The patient is receiving any form of immunosuppressant therapy.
Planned amputation
Established vasospastic disease
Glomerular filtration rate (GFR) < 30 mL/min within 7 days prior to the index procedure
The patient has a history of neutropenia, coagulopathy, and/or thrombocytopenia.
Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days prior to the index procedure
Bleeding diathesis
Known allergies or intolerance to antiplatelet, anticoagulant or thrombolytic medications including but not limited to aspirin, clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®) or heparin that cannot be medically managed.
Known allergy or intolerance to Nitinol (nickel titanium)
Known allergy to contrast agent that cannot be medically managed before treatment with steroids and/or antihistamines.
Known or suspected active infection at the time of the index procedure.
Patient is currently participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or is planning to participate in such a study prior to their completion of this study.
Patient has had a major surgical or interventional procedure unrelated to this study within 30 days prior to enrollment or is anticipated/planned to have such a procedure within 30 days after enrollment.

Exclusion criteria 20 through 25 would be assessed via baseline angiography performed at the time of index procedure:
Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device
Noted perforation of the target vessel
Stent placement required across or within 0.5 cm of the SFA/profunda femoris artery (PFA) bifurcation
Cases of chronic total occlusion/in-stent restenosis/severe calcification in which there is pre-determined inability to treat the target lesion with a single stent, or procedures pre-determined to require stent-in-stent placement to obtain patency
Presence of thrombus prior to crossing the lesion
Successful PTA treatment of a target lesion in the SFA/PPA (defined as < 50% stenosis after PTA treatment)

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Univ Klinikum LKG Graz		Graz			Austria
Klinikum Klagenfurt am Wörtherse

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 21, 2023	Feb 10, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Main Cohort	Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG0000

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.

Intent-to-treat population of the main cohort

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Interventional	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.

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

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.

Posted

Count of Participants

Participants

From the time of first use/handling of the device to 30 days from date of index procedure or study exit, whichever comes first

ID	Title	Description
OG000	Interventional	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.

Units	Counts
Participants

Secondary

Adverse Events Through 30 Days Post-Procedure

Peri-procedural (within 30 days post-index procedure) rate of adverse events

Intent to Treat population of the main cohort

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Interventional	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.

Units	Counts
Participants	OG000

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

Intent to Treat population of the main cohort

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Interventional	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.

Units	Counts
Participants

Secondary

Procedural Complications Through 30 Days Post-Procedure

Peri-procedural (within 30 days post-index procedure) rate of procedural complications

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Interventional	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.

Units	Counts

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.

Intent to Treat population of the main cohort

Posted

Count of Participants

Participants

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.

ID	Title	Description
OG000	Interventional	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.

Units

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.

There were 95 subjects with a complete set of available data to allow for endpoint analysis on the SABERX RADIANZ device.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Interventional	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.

Other Pre-specified

Fluoroscopy Time

Fluoroscopy time is the length of time during which X-rays are produced during a fluoroscopy procedure.

Intent to Treat population of the main cohort

Posted

Mean

Standard Deviation

minutes

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

ID	Title	Description
OG000	Interventional	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.

Units	Counts
Participants	OG000

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.

Intent to Treat population of the main cohort

Posted

Mean

Standard Deviation

minutes

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

ID	Title	Description
OG000	Interventional	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.

Units	Counts
Participants

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

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.

Posted

Mean

Standard Deviation

minutes

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

ID	Title	Description
OG000	Interventional	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.

Units	Counts
Participants

Other Pre-specified

Time to Hospital Discharge

Time to hospital discharge

Intent to Treat population of the main cohort. Outlier values noted for two subjects in the main cohort were removed.

Posted

Mean

Standard Deviation

hours

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

ID	Title	Description
OG000	Interventional	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.

Units	Counts
Participants	OG000

Other Pre-specified

Method to Achieve Closure of the Transradial Artery Access Site

Method to achieve closure of the transradial artery access site

Intent to Treat population of the main cohort

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Interventional	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.

Units	Counts
Participants

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.

Intent to Treat population of the main cohort

Posted

Mean

Standard Deviation

score on a scale

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)

ID	Title	Description
OG000	Interventional	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.

Units	Counts
Participants

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.

Intent to Treat population of the main cohort

Posted

Mean

Standard Deviation

score on a scale

ID	Title	Description
OG000	Interventional	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.

Other Pre-specified

Time to Hospital Discharge Eligibility

Time to hospital discharge eligibility (when physician examines and if all is well, gives discharge orders)

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.

Posted

Mean

Standard Deviation

hours

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

ID	Title	Description
OG000	Interventional	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.

Units	Counts
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.

Intent to Treat population of the main cohort

Posted

Mean

Standard Deviation

minutes

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

ID	Title	Description
OG000	Interventional	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.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Main Cohort	The main cohort consisted of 129 of the 151 total enrolled subjects in the study.	0	129	5	129	10	129
EG001	Roll-in Cohort	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.	1	22	6	22	0	22

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Rectal hemorrhage	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected129 at risk EG0010 events0 affected22 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected129 at risk EG0010 events0 affected22 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected129 at risk EG0010 events0 affected22 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected129 at risk EG0010 events0 affected22 at risk
Ischaemia	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected129 at risk EG0010 events0 affected22 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0012 events2 affected22 at risk
Iliac artery perforation	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected22 at risk
Ulcer	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected22 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected22 at risk
Haemoglobin decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected22 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Vascular access site haematoma	General disorders	MedDRA	Systematic Assessment		EG00010 events10 affected129 at risk EG0010 events0 affected22 at risk

The cohort investigated excluded patients with various, pre-existing conditions and comorbidities, and so experienced clinicians should carefully consider in whom they prescribe intervention with the S.M.A.R.T. RADIANZ™ Vascular Stent System. Future studies could be undertaken to better ascertain the PAD patient cohorts that most likely stand to benefit from specifically from radial access and the S.M.A.R.T. RADIANZ™ Vascular Stent System compared to other contemporary treatment approaches.

Certain Agreements

First MCP Posted Date

ID	Term
D058729	Peripheral Arterial Disease

Units	Counts
Participants	OG000123

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016491	Peripheral Vascular Diseases